Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2025-12-25 @ 7:04 PM
Study NCT ID:
NCT00316004
Status:
TERMINATED
Last Update Posted:
2011-05-19
First Post:
2006-04-17
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Hypertonic Resuscitation Following Severe Traumatic Brain Injury (TBI)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D001930', 'term': 'Brain Injuries'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012462', 'term': 'Saline Solution, Hypertonic'}, {'id': 'D003911', 'term': 'Dextrans'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D006982', 'term': 'Hypertonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D005936', 'term': 'Glucans'}, {'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sjmay@uw.edu', 'phone': '206-685-1302', 'title': 'Susanne May, PhD', 'organization': 'Clinical Trial Center, University of Washington, Seattle, WA'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The trial was stopped early for futility at a planned data and safety monitoring board review. The futility boundary was crossed for each of the 2 group comparisons (hypertonic saline/dextran vs normal saline and hypertonic saline vs normal saline).'}}, 'adverseEventsModule': {'timeFrame': 'The time frame was from May 2006 through May 2009, which was 3 years', 'description': "Serial blood sodium levels were drawn to monitor the effects of the hypertonic saline solutions; Serial head CT's (computed tomography) were done to monitor for increased intracranial hemorrhage; and incidents of seizures in the first 24 hours.", 'eventGroups': [{'id': 'EG000', 'title': '7.5% Hypertonic Saline/6% Dextran (HSD)', 'description': '250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.', 'otherNumAtRisk': 359, 'otherNumAffected': 0, 'seriousNumAtRisk': 359, 'seriousNumAffected': 69}, {'id': 'EG001', 'title': '7.5% Hypertonic Saline (HS)', 'description': '250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.', 'otherNumAtRisk': 341, 'otherNumAffected': 0, 'seriousNumAtRisk': 341, 'seriousNumAffected': 72}, {'id': 'EG002', 'title': '0.9% Normal Saline (NS)', 'description': '250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.', 'otherNumAtRisk': 582, 'otherNumAffected': 0, 'seriousNumAtRisk': 582, 'seriousNumAffected': 141}], 'seriousEvents': [{'term': 'Hypernatremia (sodium>160 mEq/L) requiring intervention', 'notes': 'Hypernatremia (sodium\\>160 mEq/L) requiring intervention to decrease serum sodium level to prevent additional complications.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 349, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 334, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 573, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased intracranial hemorrhage on serial head CT', 'notes': 'Increased intracranial hemorrhage on serial head CT was observed.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 349, 'numEvents': 57, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 325, 'numEvents': 60, 'numAffected': 60}, {'groupId': 'EG002', 'numAtRisk': 560, 'numEvents': 122, 'numAffected': 122}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Seizures in the first 24 hours', 'notes': 'Incidents of seizures observed in the first 24 hours', 'stats': [{'groupId': 'EG000', 'numAtRisk': 359, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 341, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 582, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Glasgow Outcome Scale-Extended (GOSE)≤4 at 6 Months: Completer Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}, {'value': '492', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '7.5% Hypertonic Saline/6% Dextran (HSD)', 'description': '250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.'}, {'id': 'OG001', 'title': '7.5% Hypertonic Saline (HS)', 'description': '250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.'}, {'id': 'OG002', 'title': '0.9% Normal Saline (NS)', 'description': '250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.'}], 'classes': [{'categories': [{'measurements': [{'value': '181', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}, {'value': '276', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.55', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.', 'groupDescription': 'The null hypothesis is that there are no differences in the percent prevalence of poor outcome between the three groups.', 'statisticalMethod': 'test for differences in proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6 months after injury', 'description': 'Glasgow outcome score extended (GOSE) contains eight categories: 1. Dead, 2. Vegetative State (VS), 3. Lower Severe Disability (Lower SD), 4. Upper Severe Disability (Upper SD), 5. Lower Moderate Disability (Lower MD), 6. Upper Moderate Disability (Upper MD), 7. Lower Good Recovery (Lower GR) and 8. Upper Good Recovery (Upper GR). A measured neurological outcome of GOSE≤4 is a poor outcome of severe disability, vegetative state, or death. Completer analysis includes only those patients with GOSE completed at 6 months after injury.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary analysis was designed as modified intent-to-treat, with all patients who had fluid connected to intravenous (IV) tubing included regardless of how much fluid was administered. Per the a priori trial design, patients for whom the fluid bag was opened but not connected to the IV were not considered enrolled in the trial.'}, {'type': 'SECONDARY', 'title': 'Subgroup of Participants With Head Abbreviated Injury Scores (AIS) Greater Than or Equal to 4 (Head AIS≥4) Assessed to Have Glasgow Outcome Scale-Extended (GOSE)≤4 at 6 Months: Imputed Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}, {'value': '331', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '7.5% Hypertonic Saline/6% Dextran (HSD)', 'description': '250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.'}, {'id': 'OG001', 'title': '7.5% Hypertonic Saline (HS)', 'description': '250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.'}, {'id': 'OG002', 'title': '0.9% Normal Saline (NS)', 'description': '250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.'}], 'classes': [{'categories': [{'measurements': [{'value': '146.1', 'groupId': 'OG000'}, {'value': '128.0', 'groupId': 'OG001'}, {'value': '219.0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.59', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.', 'groupDescription': 'The null hypothesis is that there are no differences in the percent prevalence of poor outcome between the three treatment groups among patients with head AIS≥4.', 'statisticalMethod': 'test for differences in proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted for multiple imputations', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6 months after injury', 'description': 'The Abbreviated Injury Scale (AIS) ranks injuries on a scale of 1 to 6, with 1 being minor, 2 moderate, 3 serious, 4 severe, 5 critical and 6 an unsurvivable injury. A priori secondary analyses included the subgroup of participants in each intervention group with a head AIS≥4, which is a diagnostic indicator of severe to lethal head injury. Of this subset of participants with AIS≥4, a second subset of participants with a GOSE≤4 at the 6 month follow up was analyzed. GOSE≤4 represents Upper Severe Disability or worse outcomes. 15% of subjects required imputation analysis for 6-month GOSE.', 'unitOfMeasure': 'Participants (with imputed values)', 'reportingStatus': 'POSTED', 'populationDescription': 'To adjust for 15% of subjects with absent 6-month GOSE data, an analysis using 20 hot deck imputations for the 6-month GOSE was done using data from patients who were discharged alive based on 1-month post discharge GOSE data or discharge GOSE (if 1-month post discharge data were not available), length of hospital stay, and treatment group.'}, {'type': 'PRIMARY', 'title': 'Glasgow Outcome Scale-Extended (GOSE)≤4 at 6 Months: Imputed Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '582', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '7.5% Hypertonic Saline/6% Dextran (HSD)', 'description': '250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.'}, {'id': 'OG001', 'title': '7.5% Hypertonic Saline (HS)', 'description': '250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.'}, {'id': 'OG002', 'title': '0.9% Normal Saline (NS)', 'description': '250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.'}], 'classes': [{'categories': [{'measurements': [{'value': '192.9', 'groupId': 'OG000'}, {'value': '185.4', 'groupId': 'OG001'}, {'value': '299.8', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.67', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.', 'groupDescription': 'The null hypothesis is that there are no differences in the percent prevalence of poor outcome between the three groups.', 'statisticalMethod': 'test for differences in proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted for multiple imputations.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6 months after injury', 'description': 'Glasgow outcome score extended (GOSE) contains 8 categories: 1. Dead, 2. Vegetative State, 3. Lower Severe Disability, 4. Upper Severe Disability, 5. Lower Moderate Disability, 6. Upper Moderate Disability, 7. Lower Good Recovery and 8. Upper Good Recovery. To adjust for 15% of subjects with absent 6-month GOSE data, an analysis using 20 hot deck imputations for the 6-month GOSE was done using data from patients who were discharged alive based on 1-month post discharge GOSE data or discharge GOSE (if 1-month post discharge data were not available), length of hospital stay, and treatment group.', 'unitOfMeasure': 'Participants (with imputed values)', 'reportingStatus': 'POSTED', 'populationDescription': 'To adjust for 15% of subjects with absent 6-month GOSE data, an analysis using 20 hot deck imputations for the 6-month GOSE was done using data from patients who were discharged alive based on 1-month post discharge GOSE data or discharge GOSE (if 1-month post discharge data were not available), length of hospital stay, and treatment group.'}, {'type': 'SECONDARY', 'title': 'Subgroup of Participants With Head Abbreviated Injury Scores (AIS) Greater Than or Equal to 2 (Head AIS≥2) Assessed to Have Glasgow Outcome Scale-Extended (GOSE)≤4 at 6 Months: Imputed Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}, {'value': '458', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '7.5% Hypertonic Saline/6% Dextran (HSD)', 'description': '250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.'}, {'id': 'OG001', 'title': '7.5% Hypertonic Saline (HS)', 'description': '250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.'}, {'id': 'OG002', 'title': '0.9% Normal Saline (NS)', 'description': '250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.'}], 'classes': [{'categories': [{'measurements': [{'value': '166.7', 'groupId': 'OG000'}, {'value': '150.6', 'groupId': 'OG001'}, {'value': '253.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.57', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.', 'groupDescription': 'The null hypothesis is that there are no differences in the percent prevalence of poor outcome between the three treatment groups among patients with head AIS≥2.', 'statisticalMethod': 'test for differences in proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted for multiple imputations', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6 months after injury', 'description': 'The Abbreviated Injury Scale (AIS) ranks injuries on a scale of 1 to 6, with 1 being minor, 2 moderate, 3 serious, 4 severe, 5 critical and 6 an unsurvivable injury. A priori secondary analyses included the subgroup of participants in each intervention group with a head AIS≥2, which is a diagnostic indicator of moderate to lethal head injury. Of this subset of participants with AIS≥2, a second subset of participants with a GOSE≤4 at the 6 month follow up was analyzed. GOSE≤4 represents Upper Severe Disability or worse outcomes. 15% of subjects required imputation analysis for 6-month GOSE.', 'unitOfMeasure': 'Participants (with imputed values)', 'reportingStatus': 'POSTED', 'populationDescription': 'To adjust for 15% of subjects with absent 6-month GOSE data, an analysis using 20 hot deck imputations for the 6-month GOSE was done using data from patients who were discharged alive based on 1-month post discharge GOSE data or discharge GOSE (if 1-month post discharge data were not available), length of hospital stay, and treatment group.'}, {'type': 'SECONDARY', 'title': 'Disability Rating Score (DRS) Categories of Disability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '582', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '7.5% Hypertonic Saline/6% Dextran (HSD)', 'description': '250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.'}, {'id': 'OG001', 'title': '7.5% Hypertonic Saline (HS)', 'description': '250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.'}, {'id': 'OG002', 'title': '0.9% Normal Saline (NS)', 'description': '250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.'}], 'classes': [{'title': '0-1 (none/mild disability)', 'categories': [{'measurements': [{'value': '124.8', 'groupId': 'OG000'}, {'value': '128.0', 'groupId': 'OG001'}, {'value': '232.0', 'groupId': 'OG002'}]}]}, {'title': '2-6 (Partial/Moderate Disability)', 'categories': [{'measurements': [{'value': '98.3', 'groupId': 'OG000'}, {'value': '89.4', 'groupId': 'OG001'}, {'value': '143.2', 'groupId': 'OG002'}]}]}, {'title': '7-21 (moderately severe/severe/extremely severe)', 'categories': [{'measurements': [{'value': '33.0', 'groupId': 'OG000'}, {'value': '26.6', 'groupId': 'OG001'}, {'value': '43.3', 'groupId': 'OG002'}]}]}, {'title': '22-30 (vegetative/extreme vegetative/dead)', 'categories': [{'measurements': [{'value': '102.9', 'groupId': 'OG000'}, {'value': '97.0', 'groupId': 'OG001'}, {'value': '163.4', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '.84', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.', 'groupDescription': 'The null hypothesis is that there are no differences in the percent of patients at any level of disability between the three groups.', 'statisticalMethod': 'test for proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted for multiple imputations', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6 months after injury', 'description': "The DRS is an additional measure of neurological outcome that categorizes the patient's level of disability on a scale of 0 to 29, with 0 indicating no disability to 29 indicating extreme vegetative state. To adjust for 15% of subjects with absent 6-month DRS data, an analysis using 20 hot deck imputations for the 6-month DRS was done using data from patients who were discharged alive based on 1-month post discharge DRS data or discharge DRS (if 1-month post discharge data were not available), length of hospital stay, and treatment group.", 'unitOfMeasure': 'Participants (with imputed values)', 'reportingStatus': 'POSTED', 'populationDescription': 'To adjust for 15% of subjects with absent 6-month DRS data, an analysis using 20 hot deck imputations for the 6-month DRS was done using data from patients who were discharged alive based on 1-month post discharge DRS data or discharge DRS (if 1-month post discharge data were not available), length of hospital stay, and treatment group.'}, {'type': 'SECONDARY', 'title': '28 Day Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '357', 'groupId': 'OG000'}, {'value': '340', 'groupId': 'OG001'}, {'value': '575', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '7.5% Hypertonic Saline/6% Dextran (HSD)', 'description': '250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.'}, {'id': 'OG001', 'title': '7.5% Hypertonic Saline (HS)', 'description': '250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.'}, {'id': 'OG002', 'title': '0.9% Normal Saline (NS)', 'description': '250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.'}], 'classes': [{'categories': [{'measurements': [{'value': '268', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '432', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.88', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.', 'groupDescription': 'The null hypothesis is that there are no differences in the percent of patients who were alive on the 28th day after injury between the three groups.', 'statisticalMethod': 'test for differences in proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The numbers differ from the JAMA manuscript because of typos and version control issues that were discovered after publication.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '28 days after injury', 'description': 'The patient who is admitted to the hospital after injury and is alive on the 28th day after injury. For 28-day survival, patients with missing 28-day vital status who were known to be discharged alive prior to 28 days were assumed to be alive at day 28.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'An analysis of this secondary outcome was done for all participants assigned to each of the three groups who did not refuse or were lost to follow-up prior to discharge.'}, {'type': 'SECONDARY', 'title': 'Survival at Hospital Discharge up to 6 Months From Date of Injury', 'denoms': [{'units': 'Participants', 'counts': [{'value': '354', 'groupId': 'OG000'}, {'value': '337', 'groupId': 'OG001'}, {'value': '575', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '7.5% Hypertonic Saline/6% Dextran (HSD)', 'description': '250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.'}, {'id': 'OG001', 'title': '7.5% Hypertonic Saline (HS)', 'description': '250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.'}, {'id': 'OG002', 'title': '0.9% Normal Saline (NS)', 'description': '250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.'}], 'classes': [{'categories': [{'measurements': [{'value': '263', 'groupId': 'OG000'}, {'value': '255', 'groupId': 'OG001'}, {'value': '427', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.88', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.', 'groupDescription': 'The null hypothesis is that there are no differences in the percent of patients who were alive on the day discharged from the hospital after injury between the three groups.', 'statisticalMethod': 'test for differences in proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The numbers differ from the JAMA manuscript because of typos and version control issues that were discovered after publication.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Date of hospital discharge up to 6 months from date of injury', 'description': 'The patient who is admitted to the hospital alive after injury and is alive when discharged from the hospital up to 6 months from the date of injury.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'An analysis of this secondary outcome was done for all participants assigned to each of the three groups who had relevant data.'}, {'type': 'SECONDARY', 'title': 'Acute Respiratory Distress Syndrome (ARDS)-Free Survival to Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '356', 'groupId': 'OG000'}, {'value': '337', 'groupId': 'OG001'}, {'value': '572', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '7.5% Hypertonic Saline/6% Dextran (HSD)', 'description': '250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.'}, {'id': 'OG001', 'title': '7.5% Hypertonic Saline (HS)', 'description': '250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.'}, {'id': 'OG002', 'title': '0.9% Normal Saline (NS)', 'description': '250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.'}], 'classes': [{'categories': [{'measurements': [{'value': '247', 'groupId': 'OG000'}, {'value': '239', 'groupId': 'OG001'}, {'value': '401', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.91', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.', 'groupDescription': 'The null hypothesis is that there are no differences in the percent of patients who were alive and free of ARDS from the day of injury to the 28th day after injury between the three groups.', 'statisticalMethod': 'test for differences in proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The numbers differ from the JAMA manuscript because of typos and version control issues that were discovered after publication.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From day of injury to 28 days after injury', 'description': 'The patient is alive and free of ARDS from the date of injury through to the 28th day following injury. The diagnosis of ARDS is based on standard criteria: a) hypoxia with a ratio of arterial oxygen pressure to percent oxygen delivered of less than 200; b) bilateral infiltrates on chest X-ray; and c) clinical evidence of increased left atrial pressure or pulmonary artery wedge pressure of greater than 18 mmHg.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed in each group is the actual number analyzed, which does not include participants with one of the following: 1. prehospital death; 2. transfer to another hospital without IRB approval; or 3. patient, family member, or legally authorized representative refused consent and was withdrawn from the study.'}, {'type': 'SECONDARY', 'title': 'Worst Multiple Organ Dysfunction Score (MODS) Through Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '348', 'groupId': 'OG000'}, {'value': '329', 'groupId': 'OG001'}, {'value': '558', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '7.5% Hypertonic Saline/6% Dextran (HSD)', 'description': '250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.'}, {'id': 'OG001', 'title': '7.5% Hypertonic Saline (HS)', 'description': '250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.'}, {'id': 'OG002', 'title': '0.9% Normal Saline (NS)', 'description': '250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'spread': '9.3', 'groupId': 'OG000'}, {'value': '8.6', 'spread': '9.3', 'groupId': 'OG001'}, {'value': '8.6', 'spread': '9.5', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.81', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The p-value was not adjusted for multiple comparisons. Test compares averages across all three treatment groups.', 'groupDescription': 'The null hypothesis is that there are no differences in average Worst Multiple Organ Dysfunction Scores (MODS) through day 28 between the three groups.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The numbers differ from the JAMA manuscript because of typos and version control issues that were discovered after publication.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'From day of injury to 28 days after injury', 'description': 'Multiple Organ Dysfunction Score is described as: Six organ systems were chosen: 1) respiratory; 2) renal; 3) hepatic; 4) cardiovascular; 5) hematologic; and 6) neurologica. A score of 0-4 was allotted for each organ according to function (0 being normal function through 4 for most severe dysfunction) with a maximum score of 24. The worst score based on available data (missing values were assumed normal) was taken for calculation of the aggregate score. Deaths are assigned the worst score (24).', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed in each group is the actual number analyzed, which does not include participants with one of the following: 1. prehospital death; 2. transfer to another hospital without IRB approval; or 3. patient, family member, or legally authorized representative refused consent and was withdrawn from the study.'}, {'type': 'SECONDARY', 'title': 'Ventilator-free Days Through Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '355', 'groupId': 'OG000'}, {'value': '337', 'groupId': 'OG001'}, {'value': '572', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '7.5% Hypertonic Saline/6% Dextran (HSD)', 'description': '250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.'}, {'id': 'OG001', 'title': '7.5% Hypertonic Saline (HS)', 'description': '250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.'}, {'id': 'OG002', 'title': '0.9% Normal Saline (NS)', 'description': '250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.0', 'spread': '11.6', 'groupId': 'OG000'}, {'value': '17.6', 'spread': '11.5', 'groupId': 'OG001'}, {'value': '17.4', 'spread': '11.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.77', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The p-value was not adjusted for multiple comparisons. Test compares averages across all three treatment groups.', 'groupDescription': 'The null hypothesis is that there are no differences in the average number of Ventilator-free days through day 28 between the three groups.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The numbers differ from the JAMA manuscript because of typos and version control issues that were discovered after publication.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'From day of injury to 28 days after injury', 'description': 'The number of days beginning with the day of 911 call counted as "Day 0" through day 28 that the patient did not require mechanical ventilation. Deaths are assigned the worst score (0).', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed in each group is the actual number analyzed, which does not include participants with one of the following: 1. prehospital death; 2. transfer to another hospital without IRB approval; or 3. patient, family member, or legally authorized representative refused consent and was withdrawn from the study.'}, {'type': 'SECONDARY', 'title': 'Days Alive Out of the Intensive Care Unit (ICU) Through Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '355', 'groupId': 'OG000'}, {'value': '337', 'groupId': 'OG001'}, {'value': '572', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '7.5% Hypertonic Saline/6% Dextran (HSD)', 'description': '250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.'}, {'id': 'OG001', 'title': '7.5% Hypertonic Saline (HS)', 'description': '250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.'}, {'id': 'OG002', 'title': '0.9% Normal Saline (NS)', 'description': '250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.2', 'spread': '11.5', 'groupId': 'OG000'}, {'value': '15.8', 'spread': '11.4', 'groupId': 'OG001'}, {'value': '15.6', 'spread': '11.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.76', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The p-value was not adjusted for multiple comparisons. Test compares averages across all three treatment groups.', 'groupDescription': 'The null hypothesis is that there are no differences in the average number of days alive out of the ICU through day 28 between the three groups.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The numbers differ from the JAMA manuscript because of typos and version control issues that were discovered after publication.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'From day of injury to 28 days after injury', 'description': 'The number of days the patient is alive and not being cared for in the intensive care unit', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed in each group is the actual number analyzed, which does not include participants with one of the following: 1. prehospital death; 2. transfer to another hospital without IRB approval; or 3. patient, family member, or legally authorized representative refused consent and was withdrawn from the study.'}, {'type': 'SECONDARY', 'title': 'Days Alive Out of the Hospital Through Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '354', 'groupId': 'OG000'}, {'value': '337', 'groupId': 'OG001'}, {'value': '575', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '7.5% Hypertonic Saline/6% Dextran (HSD)', 'description': '250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.'}, {'id': 'OG001', 'title': '7.5% Hypertonic Saline (HS)', 'description': '250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.'}, {'id': 'OG002', 'title': '0.9% Normal Saline (NS)', 'description': '250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.8', 'spread': '10.9', 'groupId': 'OG000'}, {'value': '10', 'spread': '11.0', 'groupId': 'OG001'}, {'value': '10.7', 'spread': '11.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.43', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The p-value was not adjusted for multiple comparisons. Test compares averages across all three treatment groups.', 'groupDescription': 'The null hypothesis is that there are no differences in the average number of days alive out of the hospital through day 28 between the three groups.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The numbers differ from the JAMA manuscript because of typos and version control issues that were discovered after publication.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'From day of injury to 28 days after injury', 'description': 'The number of days the patient is alive and no longer an inpatient in the hospital through day 28', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed in each group is the actual number analyzed, which does not include participants with one of the following: 1. prehospital death; 2. transfer to another hospital without IRB approval; or 3. patient, family member, or legally authorized representative refused consent and was withdrawn from the study.'}, {'type': 'SECONDARY', 'title': 'Presence of Nosocomial Infections', 'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'OG000'}, {'value': '313', 'groupId': 'OG001'}, {'value': '530', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '7.5% Hypertonic Saline/6% Dextran (HSD)', 'description': '250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.'}, {'id': 'OG001', 'title': '7.5% Hypertonic Saline (HS)', 'description': '250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.'}, {'id': 'OG002', 'title': '0.9% Normal Saline (NS)', 'description': '250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.'}], 'classes': [{'title': 'Nosocomial Infections ≥ 1', 'categories': [{'measurements': [{'value': '102', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}, {'value': '136', 'groupId': 'OG002'}]}]}, {'title': 'Pneumonia', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}]}]}, {'title': 'Bloodstream Infection', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}]}, {'title': 'Urinary Tract Infection', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}]}, {'title': 'Wound Infection', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.06', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.', 'groupDescription': 'The null hypothesis is that there are no differences in the percent of patients with any nosocomial infections through hospital stay between the three groups.', 'statisticalMethod': 'test for differences in proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.3', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.', 'groupDescription': 'The null hypothesis is that there are no differences in the percent of patients with pneumonia through hospital stay between the three groups.', 'statisticalMethod': 'test for differences in proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.04', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.', 'groupDescription': 'The null hypothesis is that there are no differences in the percent of patients with bloodstream infections through hospital stay between the three groups.', 'statisticalMethod': 'test for differences in proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.06', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.', 'groupDescription': 'The null hypothesis is that there are no differences in the percent of patients with urinary tract infections through hospital stay between the three groups.', 'statisticalMethod': 'test for differences in proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.88', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.', 'groupDescription': 'The null hypothesis is that there are no differences in the percent of patients with wound infections through hospital stay between the three groups.', 'statisticalMethod': 'test for differences in proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From day of injury to 28 days after injury', 'description': 'Includes one or more nosocomial infections diagnosed during the hospital stay but not present on admission to the hospital from the following list: pneumonia, bloodstream infection, urinary tract infection, and/or wound infection', 'unitOfMeasure': 'Diagnoses', 'reportingStatus': 'POSTED', 'populationDescription': 'An analysis of this secondary outcome was done for all participants assigned to each of the three groups who had relevant data. Percentages were based on population at risk.\n\nRow 1 nosocomial infections; Row 2 pneumonia; Row 3 bloodstream infections; Row 4 urinary tract infections; and Row 5 wound infections'}, {'type': 'SECONDARY', 'title': 'Total Fluids in First 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '357', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '581', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '7.5% Hypertonic Saline/6% Dextran (HSD)', 'description': '250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.'}, {'id': 'OG001', 'title': '7.5% Hypertonic Saline (HS)', 'description': '250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.'}, {'id': 'OG002', 'title': '0.9% Normal Saline (NS)', 'description': '250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.7', 'spread': '5.5', 'groupId': 'OG000'}, {'value': '6.7', 'spread': '5.5', 'groupId': 'OG001'}, {'value': '6.9', 'spread': '5.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.68', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The p-value was not adjusted for multiple comparisons. Test compares averages across all three treatment groups.', 'groupDescription': 'The null hypothesis is that there are no differences in the average amount of total fluids given within the first 24 hours between the three groups.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'First 24 hours from the time dispatch received 911 call', 'description': 'The average (mean) total amount of intravenous (IV) fluids given in the pre-hospital setting and the hospital setting in the first 24 hours following the time of the 911 call', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'An analysis of this secondary outcome was done for all participants assigned to each of the three groups who had relevant data.'}, {'type': 'SECONDARY', 'title': 'Packed Red Blood Cells (PRBC) First 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '356', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '580', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '7.5% Hypertonic Saline/6% Dextran (HSD)', 'description': '250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.'}, {'id': 'OG001', 'title': '7.5% Hypertonic Saline (HS)', 'description': '250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.'}, {'id': 'OG002', 'title': '0.9% Normal Saline (NS)', 'description': '250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'spread': '3.6', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '3.4', 'groupId': 'OG001'}, {'value': '1.5', 'spread': '4.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.43', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The p-value was not adjusted for multiple comparisons. Test compares averages across all three treatment groups.', 'groupDescription': 'The null hypothesis is that there are no differences in the average number of PRBC units given within the first 24 hours between the three groups.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'First 24 hours from the time dispatch received 911 call', 'description': 'The average (mean) number of units of packed red blood cells (PRBC) transfused in the first 24 hours following the time of the 911 call in each group.', 'unitOfMeasure': 'Unit of PRBC', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'An analysis of this secondary outcome was done for all participants assigned to each of the three groups who had relevant data.'}, {'type': 'SECONDARY', 'title': 'Discharge Disposition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '352', 'groupId': 'OG000'}, {'value': '336', 'groupId': 'OG001'}, {'value': '574', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '7.5% Hypertonic Saline/6% Dextran (HSD)', 'description': '250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.'}, {'id': 'OG001', 'title': '7.5% Hypertonic Saline (HS)', 'description': '250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.'}, {'id': 'OG002', 'title': '0.9% Normal Saline (NS)', 'description': '250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.'}], 'classes': [{'title': 'Death', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}]}]}, {'title': 'Home', 'categories': [{'measurements': [{'value': '138', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}, {'value': '253', 'groupId': 'OG002'}]}]}, {'title': 'Inpatient Rehabilitation', 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}]}, {'title': 'Skilled Nursing Facility', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}]}, {'title': 'Nursing Home or Inpatient Psychiatric Facility', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.88', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.', 'groupDescription': 'The null hypothesis is that there are no differences in the percent of patients who died during hospitalization between the three groups.', 'statisticalMethod': 'test for proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.26', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.', 'groupDescription': 'The null hypothesis is that there are no differences in the percent of patients who were discharged alive from the hospital to home between the three groups.', 'statisticalMethod': 'test for differences in proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.16', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.', 'groupDescription': 'The null hypothesis is that there are no differences in the percent of patients who were discharged alive from the hospital to inpatient rehabilitation facilities between the three groups.', 'statisticalMethod': 'test for differences in proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.17', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.', 'groupDescription': 'The null hypothesis is that there are no differences in the percent of patients who were discharged alive from the hospital to skilled nursing facilities between the three groups.', 'statisticalMethod': 'test for differences in proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Duration of hospital stay', 'description': 'Disposition of patient at the time of discharge from the acute care hospital', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed in each group is the actual number analyzed, which does not include participants with one of the following: 1. prehospital death; 2. transfer to another hospital without IRB approval; or 3. patient, family member, or legally authorized representative refused consent and was withdrawn from the study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '7.5% Hypertonic Saline/6% Dextran (HSD)', 'description': '250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.'}, {'id': 'FG001', 'title': '7.5% Hypertonic Saline (HS)', 'description': '250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.'}, {'id': 'FG002', 'title': '0.9% Normal Saline (NS)', 'description': '250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '373'}, {'groupId': 'FG001', 'numSubjects': '355'}, {'groupId': 'FG002', 'numSubjects': '603'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '359'}, {'groupId': 'FG001', 'numSubjects': '341'}, {'groupId': 'FG002', 'numSubjects': '582'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '21'}]}], 'dropWithdraws': [{'type': 'Subject was not given study fluid.', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '21'}]}]}], 'recruitmentDetails': 'Subjects were enrolled by Emergency Medicine Services (EMS) personnel in the prehospital setting based on pre-defined inclusion/exclusion criteria. The first subject was enrolled in May 2006. The last subject was enrolled in May 2009.', 'preAssignmentDetails': '1331 subjects were randomized. 1282 were included in primary imputation analysis. 49 were randomized with study fluid package opened but no study fluid was given. Reasons given were: Did not meet inclusion criteria; Met an exclusion criterion; No intravenous access; Fluid bag sterility broken; EMS responder unsure of inclusion/exclusion criteria.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '373', 'groupId': 'BG000'}, {'value': '355', 'groupId': 'BG001'}, {'value': '603', 'groupId': 'BG002'}, {'value': '1331', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': '7.5% Hypertonic Saline/6% Dextran (HSD)', 'description': '250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.'}, {'id': 'BG001', 'title': '7.5% Hypertonic Saline (HS)', 'description': '250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.'}, {'id': 'BG002', 'title': '0.9% Normal Saline (NS)', 'description': '250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Categorical', 'classes': [{'title': '<=18 years', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '95', 'groupId': 'BG003'}]}]}, {'title': 'Between 18 and 65 years', 'categories': [{'measurements': [{'value': '296', 'groupId': 'BG000'}, {'value': '305', 'groupId': 'BG001'}, {'value': '484', 'groupId': 'BG002'}, {'value': '1085', 'groupId': 'BG003'}]}]}, {'title': '>=65 years', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}, {'value': '144', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'The HSD group included 3 subjects with no age data available. The HS group included 2 subjects with no age data available. The NS group included 2 subjects with no age data available.', 'unitOfMeasure': 'participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.5', 'spread': '18.6', 'groupId': 'BG000'}, {'value': '38.6', 'spread': '17.3', 'groupId': 'BG001'}, {'value': '39.5', 'spread': '19.2', 'groupId': 'BG002'}, {'value': '39.0', 'spread': '18.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The HSD group included 3 subjects with no age data available. The HS group included 2 subjects with no age data available. The NS group included 2 subjects with no age data available.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '163', 'groupId': 'BG002'}, {'value': '317', 'groupId': 'BG003'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '284', 'groupId': 'BG000'}, {'value': '286', 'groupId': 'BG001'}, {'value': '438', 'groupId': 'BG002'}, {'value': '1008', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'The HSD group included 3 subjects with no gender data available. The HS group included 1 subject with no gender data available. The NS group included 2 subjects with no gender data available.', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '291', 'groupId': 'BG000'}, {'value': '259', 'groupId': 'BG001'}, {'value': '441', 'groupId': 'BG002'}, {'value': '991', 'groupId': 'BG003'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '162', 'groupId': 'BG002'}, {'value': '340', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1331}}, 'statusModule': {'whyStopped': 'Futility', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-05-16', 'studyFirstSubmitDate': '2006-04-17', 'resultsFirstSubmitDate': '2011-02-11', 'studyFirstSubmitQcDate': '2006-04-17', 'lastUpdatePostDateStruct': {'date': '2011-05-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-04-08', 'studyFirstPostDateStruct': {'date': '2006-04-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-05-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glasgow Outcome Scale-Extended (GOSE)≤4 at 6 Months: Completer Analysis', 'timeFrame': '6 months after injury', 'description': 'Glasgow outcome score extended (GOSE) contains eight categories: 1. Dead, 2. Vegetative State (VS), 3. Lower Severe Disability (Lower SD), 4. Upper Severe Disability (Upper SD), 5. Lower Moderate Disability (Lower MD), 6. Upper Moderate Disability (Upper MD), 7. Lower Good Recovery (Lower GR) and 8. Upper Good Recovery (Upper GR). A measured neurological outcome of GOSE≤4 is a poor outcome of severe disability, vegetative state, or death. Completer analysis includes only those patients with GOSE completed at 6 months after injury.'}, {'measure': 'Glasgow Outcome Scale-Extended (GOSE)≤4 at 6 Months: Imputed Analysis', 'timeFrame': '6 months after injury', 'description': 'Glasgow outcome score extended (GOSE) contains 8 categories: 1. Dead, 2. Vegetative State, 3. Lower Severe Disability, 4. Upper Severe Disability, 5. Lower Moderate Disability, 6. Upper Moderate Disability, 7. Lower Good Recovery and 8. Upper Good Recovery. To adjust for 15% of subjects with absent 6-month GOSE data, an analysis using 20 hot deck imputations for the 6-month GOSE was done using data from patients who were discharged alive based on 1-month post discharge GOSE data or discharge GOSE (if 1-month post discharge data were not available), length of hospital stay, and treatment group.'}], 'secondaryOutcomes': [{'measure': 'Subgroup of Participants With Head Abbreviated Injury Scores (AIS) Greater Than or Equal to 4 (Head AIS≥4) Assessed to Have Glasgow Outcome Scale-Extended (GOSE)≤4 at 6 Months: Imputed Analysis', 'timeFrame': '6 months after injury', 'description': 'The Abbreviated Injury Scale (AIS) ranks injuries on a scale of 1 to 6, with 1 being minor, 2 moderate, 3 serious, 4 severe, 5 critical and 6 an unsurvivable injury. A priori secondary analyses included the subgroup of participants in each intervention group with a head AIS≥4, which is a diagnostic indicator of severe to lethal head injury. Of this subset of participants with AIS≥4, a second subset of participants with a GOSE≤4 at the 6 month follow up was analyzed. GOSE≤4 represents Upper Severe Disability or worse outcomes. 15% of subjects required imputation analysis for 6-month GOSE.'}, {'measure': 'Subgroup of Participants With Head Abbreviated Injury Scores (AIS) Greater Than or Equal to 2 (Head AIS≥2) Assessed to Have Glasgow Outcome Scale-Extended (GOSE)≤4 at 6 Months: Imputed Analysis', 'timeFrame': '6 months after injury', 'description': 'The Abbreviated Injury Scale (AIS) ranks injuries on a scale of 1 to 6, with 1 being minor, 2 moderate, 3 serious, 4 severe, 5 critical and 6 an unsurvivable injury. A priori secondary analyses included the subgroup of participants in each intervention group with a head AIS≥2, which is a diagnostic indicator of moderate to lethal head injury. Of this subset of participants with AIS≥2, a second subset of participants with a GOSE≤4 at the 6 month follow up was analyzed. GOSE≤4 represents Upper Severe Disability or worse outcomes. 15% of subjects required imputation analysis for 6-month GOSE.'}, {'measure': 'Disability Rating Score (DRS) Categories of Disability', 'timeFrame': '6 months after injury', 'description': "The DRS is an additional measure of neurological outcome that categorizes the patient's level of disability on a scale of 0 to 29, with 0 indicating no disability to 29 indicating extreme vegetative state. To adjust for 15% of subjects with absent 6-month DRS data, an analysis using 20 hot deck imputations for the 6-month DRS was done using data from patients who were discharged alive based on 1-month post discharge DRS data or discharge DRS (if 1-month post discharge data were not available), length of hospital stay, and treatment group."}, {'measure': '28 Day Survival', 'timeFrame': '28 days after injury', 'description': 'The patient who is admitted to the hospital after injury and is alive on the 28th day after injury. For 28-day survival, patients with missing 28-day vital status who were known to be discharged alive prior to 28 days were assumed to be alive at day 28.'}, {'measure': 'Survival at Hospital Discharge up to 6 Months From Date of Injury', 'timeFrame': 'Date of hospital discharge up to 6 months from date of injury', 'description': 'The patient who is admitted to the hospital alive after injury and is alive when discharged from the hospital up to 6 months from the date of injury.'}, {'measure': 'Acute Respiratory Distress Syndrome (ARDS)-Free Survival to Day 28', 'timeFrame': 'From day of injury to 28 days after injury', 'description': 'The patient is alive and free of ARDS from the date of injury through to the 28th day following injury. The diagnosis of ARDS is based on standard criteria: a) hypoxia with a ratio of arterial oxygen pressure to percent oxygen delivered of less than 200; b) bilateral infiltrates on chest X-ray; and c) clinical evidence of increased left atrial pressure or pulmonary artery wedge pressure of greater than 18 mmHg.'}, {'measure': 'Worst Multiple Organ Dysfunction Score (MODS) Through Day 28', 'timeFrame': 'From day of injury to 28 days after injury', 'description': 'Multiple Organ Dysfunction Score is described as: Six organ systems were chosen: 1) respiratory; 2) renal; 3) hepatic; 4) cardiovascular; 5) hematologic; and 6) neurologica. A score of 0-4 was allotted for each organ according to function (0 being normal function through 4 for most severe dysfunction) with a maximum score of 24. The worst score based on available data (missing values were assumed normal) was taken for calculation of the aggregate score. Deaths are assigned the worst score (24).'}, {'measure': 'Ventilator-free Days Through Day 28', 'timeFrame': 'From day of injury to 28 days after injury', 'description': 'The number of days beginning with the day of 911 call counted as "Day 0" through day 28 that the patient did not require mechanical ventilation. Deaths are assigned the worst score (0).'}, {'measure': 'Days Alive Out of the Intensive Care Unit (ICU) Through Day 28', 'timeFrame': 'From day of injury to 28 days after injury', 'description': 'The number of days the patient is alive and not being cared for in the intensive care unit'}, {'measure': 'Days Alive Out of the Hospital Through Day 28', 'timeFrame': 'From day of injury to 28 days after injury', 'description': 'The number of days the patient is alive and no longer an inpatient in the hospital through day 28'}, {'measure': 'Presence of Nosocomial Infections', 'timeFrame': 'From day of injury to 28 days after injury', 'description': 'Includes one or more nosocomial infections diagnosed during the hospital stay but not present on admission to the hospital from the following list: pneumonia, bloodstream infection, urinary tract infection, and/or wound infection'}, {'measure': 'Total Fluids in First 24 Hours', 'timeFrame': 'First 24 hours from the time dispatch received 911 call', 'description': 'The average (mean) total amount of intravenous (IV) fluids given in the pre-hospital setting and the hospital setting in the first 24 hours following the time of the 911 call'}, {'measure': 'Packed Red Blood Cells (PRBC) First 24 Hours', 'timeFrame': 'First 24 hours from the time dispatch received 911 call', 'description': 'The average (mean) number of units of packed red blood cells (PRBC) transfused in the first 24 hours following the time of the 911 call in each group.'}, {'measure': 'Discharge Disposition', 'timeFrame': 'Duration of hospital stay', 'description': 'Disposition of patient at the time of discharge from the acute care hospital'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Traumatic', 'Brain injury'], 'conditions': ['Brain Injuries, Traumatic']}, 'referencesModule': {'references': [{'pmid': '20924011', 'type': 'RESULT', 'citation': 'Bulger EM, May S, Brasel KJ, Schreiber M, Kerby JD, Tisherman SA, Newgard C, Slutsky A, Coimbra R, Emerson S, Minei JP, Bardarson B, Kudenchuk P, Baker A, Christenson J, Idris A, Davis D, Fabian TC, Aufderheide TP, Callaway C, Williams C, Banek J, Vaillancourt C, van Heest R, Sopko G, Hata JS, Hoyt DB; ROC Investigators. Out-of-hospital hypertonic resuscitation following severe traumatic brain injury: a randomized controlled trial. JAMA. 2010 Oct 6;304(13):1455-64. doi: 10.1001/jama.2010.1405.'}, {'pmid': '25072443', 'type': 'DERIVED', 'citation': 'Tisherman SA, Schmicker RH, Brasel KJ, Bulger EM, Kerby JD, Minei JP, Powell JL, Reiff DA, Rizoli SB, Schreiber MA. Detailed description of all deaths in both the shock and traumatic brain injury hypertonic saline trials of the Resuscitation Outcomes Consortium. Ann Surg. 2015 Mar;261(3):586-90. doi: 10.1097/SLA.0000000000000837.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if hypertonic saline with and without dextran can improve neurologic outcomes in victims of severe traumatic brain injury (TBI).\n\nInjury and lost blood from trauma can cause your body to go into shock (low blood pressure related to blood loss). This decreased blood flow can lead to organ damage. In order to restore the blood pressure and blood flow, the medics give fluids into the patients\' veins as soon as possible. This is called "resuscitation". The fluid most commonly used is "isotonic" or one that is the same salt concentration as the blood. The investigators are trying to determine if infusing a "hypertonic" fluid or one more concentrated than the blood can increase the blood pressure and restore blood flow more efficiently. The hypertonic fluids they are using are called hypertonic saline with dextran (HSD) and hypertonic saline (no dextran). Hypertonic saline is a salt solution that is slightly more concentrated than blood. Dextran is a sugar solution.', 'detailedDescription': 'To determine if prehospital administration of 7.5% Hypertonic Saline in 6% Dextran-70 (HSD) OR 7.5% Hypertonic Saline (HS) compared to current standard therapy with NS as an initial resuscitation fluid affects neurological outcome following severe traumatic brain injury.\n\nTrauma is the leading cause of death among North Americans between the ages of 1 and 44 years. The majority of these deaths result from hypovolemic shock or severe brain injury. Patients in hypovolemic shock develop a state of systemic tissue ischemia then a subsequent reperfusion injury at the time of fluid resuscitation. Conventional resuscitation involves the IV administration of a large volume of isotonic or slightly hypotonic (lactated ringers, LR) solutions beginning in the pre-hospital setting. Although not conclusive, prior studies have suggested that alternative resuscitation with hypertonic saline (7.5%) solutions may reduce morbidity or mortality in these patients. Furthermore, hypertonic fluids may have specific advantages in the brain-injured patient, as they may aid in the rapid restoration of cerebral perfusion and prevent extravascular fluid sequestration, thereby limiting secondary brain injury. In addition, recent studies have demonstrated that hypertonicity significantly alters the activation of inflammatory cells, an effect that may reduce subsequent organ injury from ischemia-reperfusion and decrease nosocomial infection.\n\nThis study is a randomized, double-blind, three-arm placebo controlled trial designed to evaluate the clinical outcome of trauma patients with severe TBI as manifested by a pre-hospital GCS of 8 or less. Patients will be randomized to a single 250cc IV dose of 7.5% saline in 6% Dextran-70 (HSD), 7.5% saline (HS) or normal saline as the initial fluid for pre-hospital resuscitation. No additional interventions will occur once the patient is admitted to the hospital. In hospital data collection will last up to 28 days. Patients will have neurologic outcome measurements at discharge, 1 month post discharge, and 6 months post injury. Enrollment will be restricted to age ≥ 15 years or ≥ 50 kg if age is unknown.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Blunt trauma\n* Pre-hospital Glasgow Coma Scale equal to or less than 8(GCS≤8)\\*\n* Age 15 years or older or 50 kg or more\n\n * Patients who met the inclusion criteria above and did not meet the exclusion criteria below but who had systolic blood pressure (SBP) ≤70 or SBP\\>70 and SBP≤90 and heart rate (HR)≥108 were included in the Hypertonic Resuscitation following Traumatic Injury study that focused on shock patients who may or may not have a traumatic brain injury (TBI). In other words, patients with both TBI and shock would not be included in this study of TBI patients without shock at the time of enrollment.\n\nExclusion Criteria:\n\n* Known or suspected pregnancy\n* Age younger than 15 years or less than 50 kg if age unknown\n* Ongoing pre-hospital cardiopulmonary resuscitation (CPR)\n* Administration of more than 2L crystalloid or any colloid or blood products\n* Severe hypothermia (T less than 28C)\n* Drowning or asphyxia due to hanging\n* Burns TBSA more than 20%\n* Isolated penetrating injury to the head\n* Inability to obtain pre-hospital intravenous access\n* Time of call received at dispatch to study intervention more than four hours\n* Known prisoners'}, 'identificationModule': {'nctId': 'NCT00316004', 'briefTitle': 'Hypertonic Resuscitation Following Severe Traumatic Brain Injury (TBI)', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Phase 3 Study of Hypertonic Resuscitation Following Severe Traumatic Brain Injury (TBI)', 'orgStudyIdInfo': {'id': '28226-A - IND 12505'}, 'secondaryIdInfos': [{'id': '5U01HL077863-05', 'link': 'https://reporter.nih.gov/quickSearch/5U01HL077863-05', 'type': 'NIH'}, {'id': 'IND #12505 TBI cohort', 'type': 'OTHER', 'domain': 'FDA'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '7.5% hypertonic saline/6% dextran (HSD)', 'description': '250 ml intravenous bolus administration of 7.5% saline/6% dextran 70', 'interventionNames': ['Drug: 7.5% Hypertonic Saline in 6% Dextran-70 (HSD)']}, {'type': 'EXPERIMENTAL', 'label': '7.5% hypertonic saline (HS)', 'description': '250 ml intravenous bolus administration of 7.5% hypertonic saline', 'interventionNames': ['Drug: 7.5% Hypertonic Saline (HS)']}, {'type': 'PLACEBO_COMPARATOR', 'label': '0.9% normal saline (NS)', 'description': '250 ml intravenous bolus administration of 0.9% saline', 'interventionNames': ['Drug: 0.9% Normal Saline (NS)']}], 'interventions': [{'name': '7.5% Hypertonic Saline in 6% Dextran-70 (HSD)', 'type': 'DRUG', 'otherNames': ['RescueFlo'], 'description': '250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 administered as a one-time bolus fluid for initial resuscitation to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.', 'armGroupLabels': ['7.5% hypertonic saline/6% dextran (HSD)']}, {'name': '7.5% Hypertonic Saline (HS)', 'type': 'DRUG', 'description': '250 ml intravenous bolus administration of 7.5% hypertonic saline administered as a one-time bolus fluid for initial resuscitation to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.', 'armGroupLabels': ['7.5% hypertonic saline (HS)']}, {'name': '0.9% Normal Saline (NS)', 'type': 'DRUG', 'description': '250 ml intravenous bolus administration of 0.9% saline administered as a one-time bolus fluid for initial resuscitation to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.', 'armGroupLabels': ['0.9% normal saline (NS)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35249', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Alabama Resuscitation Center, University of Alabama', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'Orange County/UC Irvine', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'UCSD-San Diego Resuscitation Research Center', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'Iowa Resuscitation Network, University of Iowa Carver College of Medicine', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Portland Resuscitation Outcomes Consortium, Oregon Health & Sciences University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'The Pittsburgh Resuscitation Network, University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '38103', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'The Regional Medical Center at Memphis', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Dallas Center for Resuscitation Research, University of Texas Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Seattle-King County Center for Resuscitation Research, University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Milwaukee Resuscitation Network, Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': 'K1Y4E9', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University of Ottawa/University of British Columbia Collaborative RCC, Ottawa Health Research Institute', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'M5B1W8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto Regional Resuscitation Research Out-of-Hospital Network, University of Toronto', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Myron L Weisfeldt, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Resuscitation Outcomes Consortium'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}, {'name': 'National Institute of Neurological Disorders and Stroke (NINDS)', 'class': 'NIH'}, {'name': 'U.S. Army Medical Research and Development Command', 'class': 'FED'}, {'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}, {'name': 'Canadian Department of National Defense', 'class': 'OTHER_GOV'}, {'name': 'Heart and Stroke Foundation of Canada', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Gerald Van Belle, PhD/Principal Investigator', 'oldOrganization': 'Resuscitation Outcomes Consortium Data Coordinating Center'}}}}