Ignite Creation Date:
2025-12-24 @ 5:54 PM
Ignite Modification Date:
2025-12-30 @ 12:57 AM
Study NCT ID:
NCT04667468
Status:
COMPLETED
Last Update Posted:
2024-12-18
First Post:
2020-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Cold Stored Platelet in Hemorrhagic Shock
Sponsor:
Organization:
Raw JSON
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'412-215-7025', 'title': 'Dr. Jason Sperry', 'organization': 'University of Pittsburgh'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '30 days', 'eventGroups': [{'id': 'EG000', 'title': 'Cold-stored Platelet (CSP)', 'description': 'early infusion of one apheresis unit urgent release cold stored platelets (CSP)\n\nCold Stored Platelets (CSP): early infusion of urgent release CSP', 'otherNumAtRisk': 102, 'deathsNumAtRisk': 102, 'otherNumAffected': 0, 'seriousNumAtRisk': 102, 'deathsNumAffected': 12, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': 'Standard Care', 'description': 'resuscitation, blood and blood component transfusion per site standard care\n\nStandard Care: standard care including blood and blood component therapy', 'otherNumAtRisk': 98, 'deathsNumAtRisk': 98, 'otherNumAffected': 0, 'seriousNumAtRisk': 98, 'deathsNumAffected': 13, 'seriousNumAffected': 4}], 'seriousEvents': [{'term': 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'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Enrollment through 24 hours', 'description': 'Mortality within 24 hours', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '3-hour Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cold-stored Platelet (CSP)', 'description': 'early infusion of one apheresis unit urgent release cold stored platelets (CSP)\n\nCold Stored Platelets (CSP): early infusion of urgent release CSP'}, {'id': 'OG001', 'title': 'Standard Care', 'description': 'resuscitation, blood and blood component transfusion per site standard care\n\nStandard Care: standard care including blood and blood component therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Enrollment through 3 hours', 'description': 'Mortality within 3 hours', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'In Hospital Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cold-stored Platelet (CSP)', 'description': 'early infusion of one apheresis unit urgent release cold stored platelets (CSP)\n\nCold Stored Platelets (CSP): early infusion of urgent release CSP'}, {'id': 'OG001', 'title': 'Standard Care', 'description': 'resuscitation, blood and blood component transfusion per site standard care\n\nStandard Care: standard care including blood and blood component therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Enrollment through 30 days or discharge', 'description': 'mortality in-hospital', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hemorrhagic Death Alone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cold-stored Platelet (CSP)', 'description': 'early infusion of one apheresis unit urgent release cold stored platelets (CSP)\n\nCold Stored Platelets (CSP): early infusion of urgent release CSP'}, {'id': 'OG001', 'title': 'Standard Care', 'description': 'resuscitation, blood and blood component transfusion per site standard care\n\nStandard Care: standard care including blood and blood component therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Enrollment through 24 hours', 'description': 'mortality due to hemorrhage', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Acute Respiratory Distress Syndrome (ARDS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cold-stored Platelet (CSP)', 'description': 'early infusion of one apheresis unit urgent release cold stored platelets (CSP)\n\nCold Stored Platelets (CSP): early infusion of urgent release CSP'}, {'id': 'OG001', 'title': 'Standard Care', 'description': 'resuscitation, blood and blood component transfusion per site standard care\n\nStandard Care: standard care including blood and blood component therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Enrollment through 48 hours', 'description': 'Berlin definition of mild ARDS will determine incidence and will be further stratified into Moderate and Severe', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Thromboembolic Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cold-stored Platelet (CSP)', 'description': 'early infusion of one apheresis unit urgent release cold stored platelets (CSP)\n\nCold Stored Platelets (CSP): early infusion of urgent release CSP'}, {'id': 'OG001', 'title': 'Standard Care', 'description': 'resuscitation, blood and blood component transfusion per site standard care\n\nStandard Care: standard care including blood and blood component therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Enrollment through 48 hours', 'description': 'Incidence of pulmonary embolism, venous thrombosis, or arterial thrombosis', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '30-day Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cold-stored Platelet (CSP)', 'description': 'early infusion of one apheresis unit urgent release cold stored platelets (CSP)\n\nCold Stored Platelets (CSP): early infusion of urgent release CSP'}, {'id': 'OG001', 'title': 'Standard Care', 'description': 'resuscitation, blood and blood component transfusion per site standard care\n\nStandard Care: standard care including blood and blood component therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Enrollment through 30 days', 'description': 'mortality within 30 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cold-stored Platelet (CSP)', 'description': 'early infusion of one apheresis unit urgent release cold stored platelets (CSP)\n\nCold Stored Platelets (CSP): early infusion of urgent release CSP'}, {'id': 'FG001', 'title': 'Standard Care', 'description': 'resuscitation, blood and blood component transfusion per site standard care\n\nStandard Care: standard care including blood and blood component therapy'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '102'}, {'groupId': 'FG001', 'numSubjects': '98'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '102'}, {'groupId': 'FG001', 'numSubjects': '98'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cold-stored Platelet (CSP)', 'description': 'early infusion of one apheresis unit urgent release cold stored platelets (CSP)\n\nCold Stored Platelets (CSP): early infusion of urgent release CSP'}, {'id': 'BG001', 'title': 'Standard Care', 'description': 'resuscitation, blood and blood component transfusion per site standard care\n\nStandard Care: standard care including blood and blood component therapy'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '35.3', 'spread': '14.4', 'groupId': 'BG000'}, {'value': '34.4', 'spread': '13.5', 'groupId': 'BG001'}, {'value': '34.8', 'spread': '13.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '163', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}, {'title': 'Other including Asian and unknown', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Patients can be in more than one group.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-12-17', 'size': 606950, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-08-19T13:17', 'hasProtocol': True}, {'date': '2023-07-25', 'size': 170456, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-11-02T10:24', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'permuted block design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2023-11-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-13', 'studyFirstSubmitDate': '2020-11-24', 'resultsFirstSubmitDate': '2024-08-19', 'studyFirstSubmitQcDate': '2020-12-07', 'lastUpdatePostDateStruct': {'date': '2024-12-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-12-13', 'studyFirstPostDateStruct': {'date': '2020-12-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-12-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Study Feasibility', 'timeFrame': 'Enrollment through 30 days or discharge', 'description': 'Proportion of eligible patients that can be randomized, enrolled, adhere to protocol, and completed follow-up'}], 'secondaryOutcomes': [{'measure': '24-hour Mortality', 'timeFrame': 'Enrollment through 24 hours', 'description': 'Mortality within 24 hours'}, {'measure': '3-hour Mortality', 'timeFrame': 'Enrollment through 3 hours', 'description': 'Mortality within 3 hours'}, {'measure': 'In Hospital Mortality', 'timeFrame': 'Enrollment through 30 days or discharge', 'description': 'mortality in-hospital'}, {'measure': 'Hemorrhagic Death Alone', 'timeFrame': 'Enrollment through 24 hours', 'description': 'mortality due to hemorrhage'}, {'measure': 'Incidence of Acute Respiratory Distress Syndrome (ARDS)', 'timeFrame': 'Enrollment through 48 hours', 'description': 'Berlin definition of mild ARDS will determine incidence and will be further stratified into Moderate and Severe'}, {'measure': 'Incidence of Thromboembolic Events', 'timeFrame': 'Enrollment through 48 hours', 'description': 'Incidence of pulmonary embolism, venous thrombosis, or arterial thrombosis'}, {'measure': '30-day Mortality', 'timeFrame': 'Enrollment through 30 days', 'description': 'mortality within 30 days'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['platelet', 'hemorrhagic shock', 'trauma'], 'conditions': ['Trauma', 'Hemorrhage']}, 'referencesModule': {'references': [{'pmid': '38708880', 'type': 'DERIVED', 'citation': 'Sperry JL, Guyette FX, Rosario-Rivera BL, Kutcher ME, Kornblith LZ, Cotton BA, Wilson CT, Inaba K, Zadorozny EV, Vincent LE, Harner AM, Love ET, Doherty JE, Cuschieri J, Kornblith AE, Fox EE, Bai Y, Hoffman MK, Seger CP, Hudgins J, Mallett-Smith S, Neal MD, Leeper CM, Spinella PC, Yazer MH, Wisniewski SR; Cold Stored Platelet for Hemorrhagic Shock (CRISP-HS) Study Group. Early Cold Stored Platelet Transfusion Following Severe Injury: A Randomized Clinical Trial. Ann Surg. 2024 Aug 1;280(2):212-221. doi: 10.1097/SLA.0000000000006317. Epub 2024 May 6.'}]}, 'descriptionModule': {'briefSummary': 'The Cold Stored Platelet Early Intervention in Hemorrhagic Shock (CriSP-HS) trial is a proposed 3 year, open label, multi-center, randomized trial designed to determine the feasibility, efficacy, and safety of urgent release cold stored platelets (CSP) in patients in hemorrhagic shock. Patients will be randomized to receive either standard care or early infusion of urgent release cold stored platelets (CSP). The proposed pilot study will utilize 5 level-1 trauma centers from within the LITES network and will enroll approximately 200 patients. The primary outcome for the pilot trial is feasibility, with principal secondary clinical outcome of 24 hour mortality.', 'detailedDescription': 'The acute management of the severely injured patient with hemorrhage following trauma center arrival has evolved over the last decade.\n\nCurrent treatment priorities include prevention of coagulopathy through minimization of crystalloid and early blood component resuscitation including plasma and platelets in equal ratios with packed red blood cells. These in-hospital practices, termed damage control resuscitation, are widely used in both battlefield and civilian resuscitation following traumatic injury.\n\nInitiation of the tenets of damage control resuscitation early, soon after arrival, has the potential to reduce downstream complications attributable to hemorrhage by intervening closer to the time of injury, prior to the development of coagulopathy; irreversible shock; and the ensuing inflammatory response. Other blood constituents have recently been shown to be beneficial when given early. Thawed plasma transfusion has been shown to safely reduce 30-day mortality when infused early, in the prehospital setting, in patients at risk of hemorrhagic shock and this separation of survival occurs within the first 3 hours. Platelet transfusion is associated with improved outcomes in the acutely bleeding patients. Cold Stored Platelets have been reported to reduce blood loss when provided for hemorrhage and are a more effective hemostatic product.\n\nCold stored platelets are less likely to become bacterial contaminated and were the standard of care platelet product until the 1980s. Despite this history and potential benefits, the risks associated with urgent release cold stored platelets and their respective efficacy and function over time are not known in patients with hemorrhagic shock.\n\nBy providing Cold Stored Platelets in an urgent release fashion following injury, a potentially superior hemostatic agent is given early, closer to the time of injury. The current pilot trial was designed to determine the feasibility, efficacy and safety of urgent release cold stored platelets as compared to standard care in injured patients in hemorrhagic shock. There are no high-level data which appropriately characterize the urgent release use of cold stored platelets out to 14 days or their function over that time period as compared to standard room temperature platelets. These results will be able to inform future large randomized clinical trials allowing the most appropriate injured population, inclusion criteria, and primary outcome to be selected and utilized.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients with traumatic injury who meet the following criteria:\n\n1. Has 2 or more of any of the following:\n\n 1. Hypotension (systolic blood pressure ≤ 90 mmHg) in the prehospital or emergency department setting\n 2. Penetrating mechanism\n 3. Abdominal or Extended Focused Assessment with Sonography for Trauma (FAST) abdominal ultrasound is positive or equivocal or deferred by clinical team due to emergent visit to Interventional Radiology or a need for emergent laparotomy, thoracotomy, or vascular exploration\n 4. Heart rate ≥ 120 in the prehospital or emergency department setting\n\n AND\n2. Clinical team deems Operating Room (laparotomy, thoracotomy or vascular exploration) or Interventional Radiology for embolization within 60 minutes of arrival to be clinically indicated.\n\nExclusion Criteria:\n\n1. Wearing "NO CriSP" opt-out bracelet\n2. Age \\>90 or \\<15 years of age\n3. Isolated fall from standing injury mechanism\n4. Prisoner\n5. Pregnant\n6. Traumatic arrest with \\>5 minutes of CPR without return of vital signs\n7. Brain matter exposed or penetrating brain injury (gun shot wound \\[GSW\\])\n8. Isolated drowning or hanging victims\n9. Isolated burns \\> estimated 20% total body surface area\n10. Objection to study voiced by subject or family member in Emergency Department\n\nInclusion and exclusion criteria will be assessed based on information available at the time of enrollment. If, after subsequent review, it is determined that the subject did not meet inclusion criteria and/or met exclusion criteria, the subject will remain enrolled in the study based on the intent-to-treat principle.\n\nIf a verbal report must be used in lieu of physical documentation or directly witnessing inclusion criteria, documentation of the verbal report will serve as the source documentation for determining eligibility.'}, 'identificationModule': {'nctId': 'NCT04667468', 'acronym': 'CriSP-HS', 'briefTitle': 'Cold Stored Platelet in Hemorrhagic Shock', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Cold Stored Platelet Early Intervention in Hemorrhagic Shock (CriSP-HS) Trial', 'orgStudyIdInfo': {'id': 'STUDY21100002'}, 'secondaryIdInfos': [{'id': 'W81XWH-16-D-0024', 'type': 'OTHER_GRANT', 'domain': 'Department of Defense'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cold-stored Platelet (CSP)', 'description': 'early infusion of one apheresis unit urgent release cold stored platelets (CSP)', 'interventionNames': ['Biological: Cold Stored Platelets (CSP)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Care', 'description': 'resuscitation, blood and blood component transfusion per site standard care', 'interventionNames': ['Biological: Standard Care']}], 'interventions': [{'name': 'Cold Stored Platelets (CSP)', 'type': 'BIOLOGICAL', 'description': 'early infusion of urgent release CSP', 'armGroupLabels': ['Cold-stored Platelet (CSP)']}, {'name': 'Standard Care', 'type': 'BIOLOGICAL', 'description': 'standard care including blood and blood component therapy', 'armGroupLabels': ['Standard Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94110', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '39216', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'University of Mississippi', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Health Sciences Center Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Jason Sperry, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}, {'name': 'Frank Guyette, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'Data will become available after publication of the primary manuscript.', 'ipdSharing': 'YES', 'description': 'De-identified data may be shared with the funding agency as well as other researchers upon request to the Principal Investigator.', 'accessCriteria': 'Requests for data will be submitted in writing and reviewed by the Principal Investigator.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jason Sperry', 'class': 'OTHER'}, 'collaborators': [{'name': 'United States Department of Defense', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jason Sperry', 'investigatorAffiliation': 'University of Pittsburgh'}}}}