Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2026-03-18 @ 12:37 AM
Study NCT ID:
NCT02203292
Status:
COMPLETED
Last Update Posted:
2016-08-01
First Post:
2014-07-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transfusion Requirements After Head Trauma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}], 'ancestors': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-28', 'studyFirstSubmitDate': '2014-07-27', 'studyFirstSubmitQcDate': '2014-07-27', 'lastUpdatePostDateStruct': {'date': '2016-08-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hemoglobin difference', 'timeFrame': '14 days', 'description': 'Hemoglobin difference between restrictive and liberal groups'}], 'secondaryOutcomes': [{'measure': 'Number of transfused patients', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 4 weeks'}, {'measure': 'Number of red blood cell packages transfused', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 4 weeks'}, {'measure': 'ICU mortality', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 4 weeks'}, {'measure': 'Hospital mortality', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 4 weeks'}, {'measure': '180 days mortality', 'timeFrame': 'Participants will be followed for 180 after hospital discharge'}, {'measure': 'Blood stream infection', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 4 weeks', 'description': 'Positive blood culture with a pathogenic microorganism'}, {'measure': 'Re-bleeding', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 4 weeks'}, {'measure': 'Intensity of measures to reduce intracranial pressure', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 4 weeks', 'description': 'Measures to reduce intracranial pressure such as sedation, hypertonic solutions, hypothermia, liquorice drainage, decompressive craniectomy or hyperventilation'}, {'measure': 'Hospital length of stay', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 4 weeks'}, {'measure': 'ICU length of stay', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 4 weeks'}, {'measure': 'Mechanical ventilation free days', 'timeFrame': '28 days', 'description': 'Days breathing without assistance from hospital admission to day 28.'}, {'measure': 'Extended Glasgow Outcome Scale at hospital discharge', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 4 weeks'}, {'measure': 'Extended Glasgow Outcome Scale after 6 months', 'timeFrame': '180 days'}, {'measure': 'Myocardial Infarction', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 4 weeks'}, {'measure': 'Acute Respiratory Distress Syndrome', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 4 weeks'}, {'measure': 'Septic Shock', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 4 weeks'}, {'measure': 'Cerebral autoregulation', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 4 weeks', 'description': 'Cerebral autoregulation as measure by the transcranial doppler'}, {'measure': 'Pulsatility index', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 4 weeks', 'description': 'Pulsatility index as measure by the transcranial doppler'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Traumatic Brain Injury', 'Blood Transfusion'], 'conditions': ['Traumatic Brain Injury']}, 'referencesModule': {'references': [{'pmid': '41114449', 'type': 'DERIVED', 'citation': 'Carson JL, Stanworth SJ, Dennis JA, Fergusson DA, Pagano MB, Roubinian NH, Turgeon AF, Valentine S, Trivella M, Doree C, Hebert PC. Transfusion thresholds and other strategies for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2025 Oct 20;10(10):CD002042. doi: 10.1002/14651858.CD002042.pub6.'}, {'pmid': '38961443', 'type': 'DERIVED', 'citation': 'Gobatto ALN, Solla D, Brasil S, Taccone FS, Carlotti CG Jr, Malbouisson LMS, Paiva WS. Progressive hemorrhagic injury and ischemia after severe traumatic brain injury according to hemoglobin transfusion thresholds: a post-hoc analysis of the transfusion requirements after head trauma trial. Crit Care. 2024 Jul 3;28(1):218. doi: 10.1186/s13054-024-04981-5. No abstract available.'}, {'pmid': '34932836', 'type': 'DERIVED', 'citation': 'Carson JL, Stanworth SJ, Dennis JA, Trivella M, Roubinian N, Fergusson DA, Triulzi D, Doree C, Hebert PC. Transfusion thresholds for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD002042. doi: 10.1002/14651858.CD002042.pub5.'}, {'pmid': '30871608', 'type': 'DERIVED', 'citation': 'Gobatto ALN, Link MA, Solla DJ, Bassi E, Tierno PF, Paiva W, Taccone FS, Malbouisson LM. Transfusion requirements after head trauma: a randomized feasibility controlled trial. Crit Care. 2019 Mar 12;23(1):89. doi: 10.1186/s13054-018-2273-9.'}]}, 'descriptionModule': {'briefSummary': 'TRAHT is a pilot randomized clinical trial designed to evaluate safety and feasibility of two red blood cells transfusion thresholds in moderate or severe traumatic brain injured patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age equal to or greater than 18 years\n* Moderate or severe traumatic brain injury, defined as Glasgow coma scale less than or equal to 12 at hospital admission\n* Hemoglobin lower than 9.0 g/dL within 7 days from hospital admission\n\nExclusion Criteria:\n\n* Glasgow coma scale equal to 3 with dilated pupils bilaterally\n* Previous neurological sequelae\n* Pregnant women\n* Jehovah's Witnesses\n* Hemorrhagic shock at randomization\n* Moribund patients\n* Unable to provide consent"}, 'identificationModule': {'nctId': 'NCT02203292', 'acronym': 'TRAHT', 'briefTitle': 'Transfusion Requirements After Head Trauma', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Transfusion Requirements After Head Trauma', 'orgStudyIdInfo': {'id': '32520914.3.0000.0068'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Liberal', 'description': 'Liberal transfusion strategy. Patients will have red blood cells transfused only if Hb \\< 9.0 g/dL', 'interventionNames': ['Behavioral: Liberal transfusion strategy']}, {'type': 'EXPERIMENTAL', 'label': 'Restrictive', 'description': 'Restrictive transfusion strategy. Patients will have red blood cells transfused only if Hb \\< 7.0 g/dL', 'interventionNames': ['Behavioral: Restrictive transfusion strategy']}], 'interventions': [{'name': 'Liberal transfusion strategy', 'type': 'BEHAVIORAL', 'description': 'Patients will have red blood cells transfused only if Hb \\< 9.0 g/dL', 'armGroupLabels': ['Liberal']}, {'name': 'Restrictive transfusion strategy', 'type': 'BEHAVIORAL', 'description': 'Patients will have red blood cells transfused only if Hb \\< 7.0 g/dL', 'armGroupLabels': ['Restrictive']}]}, 'contactsLocationsModule': {'locations': [{'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'André LN Gobatto, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sao Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'André Luiz Nunes Gobatto', 'investigatorAffiliation': 'University of Sao Paulo'}}}}