Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-31 @ 4:38 AM
Study NCT ID:
NCT06948669
Status:
COMPLETED
Last Update Posted:
2025-04-29
First Post:
2025-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brain Death and Organ Donation in Tunisian Intensive Care Units
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D003128', 'term': 'Coma'}], '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'}, {'id': 'D014474', 'term': 'Unconsciousness'}, {'id': 'D003244', 'term': 'Consciousness Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2023-11-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-24', 'studyFirstSubmitDate': '2025-04-11', 'studyFirstSubmitQcDate': '2025-04-24', 'lastUpdatePostDateStruct': {'date': '2025-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Brain death incidence', 'timeFrame': '0-12 months', 'description': 'Proportion of patients progressing to brain death (clinical + CT angiography).'}, {'measure': 'Family donation refusal rate', 'timeFrame': 'At time of brain death confirmation (through study completion, an average of 1 year)', 'description': 'Percentage of families declining organ donation, with reasons'}], 'secondaryOutcomes': [{'measure': 'Multivariate analysis of brain death predictors', 'timeFrame': 'From ICU admission to outcome determination (up to 1 year)', 'description': 'Adjusted odds ratios (OR) for: 1) hemorrhagic stroke, 2) traumatic brain injury, and 3) ICU stay \\>14 days as independent predictors of brain death progression'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Organ donation refusal', 'ICU donor management', 'Cultural barriers', 'Hemorrhagic stroke outcome'], 'conditions': ['Brain Injury', 'Coma', 'Organ Transplants']}, 'referencesModule': {'references': [{'pmid': '40794438', 'type': 'DERIVED', 'citation': 'Slama I, Chouchene I, Ghammam R, Durin L, Naija W, Ziadi J, Ben Saad H. Predictors of brain death and barriers to organ donation in north African intensive care units: a multicenter prospective study on severe coma patients. Libyan J Med. 2025 Dec;20(1):2545049. doi: 10.1080/19932820.2025.2545049. Epub 2025 Aug 12.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this observational study was to identify factors associated with the progression to brain death in critically ill patients with severe brain injuries in Tunisian intensive care units (ICUs). The main questions it aimed to answer were:\n\nWhat medical factors (e.g., type of brain injury, ICU stay duration) increased the likelihood of progressing to brain death in these patients?\n\nWhat patient characteristics (e.g., age, comorbidities) influenced the risk of brain death?\n\nWhat were the reasons behind low organ donation rates in Tunisia, including family refusal and hospital-level barriers?\n\nParticipants were:\n\nAdults with severe coma (Glasgow Coma Scale ≤ 8) requiring mechanical ventilation in Tunisian ICUs.\n\nData were collected as part of routine medical care, including information about medical factors, patient characteristics, and family attitudes towards organ donation, without any additional interventions beyond standard care.\n\nThe study was conducted from November 2022 to November 2023 across three ICUs: Sahloul, Farhat Hached, and Mohamed Taher Maamouri Hospitals.', 'detailedDescription': 'Background\n\nBrain death (BD) is a legally and medically recognized condition under which organ donation may occur. However, organ donation rates in Tunisia remain low compared to international benchmarks. There is a need to better understand the factors influencing the progression to brain death in ICU patients, as well as the sociocultural and institutional barriers to organ donation in this setting.\n\nObjectives\n\nThis study aimed to:\n\nIdentify clinical predictors of brain death among critically ill patients with severe brain injuries\n\nExplore reasons for organ donation refusal by families\n\nIdentify hospital-level barriers in the organ donation process\n\nStudy Design and Setting\n\nThis was a prospective observational cohort study conducted between November 2022 and November 2023 in three Tunisian intensive care units:\n\nSahloul University Hospital (trauma center)\n\nFarhat Hached University Hospital\n\nMohamed Taher Maamouri Hospital\n\nParticipants\n\nAdult patients (≥18 years) admitted with severe coma (Glasgow Coma Scale ≤ 8) requiring mechanical ventilation were included. Patients with terminal illnesses unrelated to brain injury were excluded.\n\nProcedures Data Collection\n\nData were prospectively collected using a standardized form developed and validated by experts in intensive care and the Tunisian National Centre for Organ Promotion and Transplantation (CNPTO).\n\nThe collected variables included:\n\nDemographic information (e.g., age, sex)\n\nClinical characteristics (e.g., Glasgow Coma Scale on ICU admission, comorbidities, primary diagnosis)\n\nPatient outcomes (e.g., progression to brain death, ICU discharge, or death from other causes)\n\nLength of ICU stay\n\nOrgan donation process variables (e.g., whether families were approached, family consent or refusal, organ procurement, reasons for refusal)\n\nFamily approaches were conducted by the national transplant coordination team from the CNPTO.\n\nNo experimental interventions were applied. All procedures were part of standard ICU care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This prospective observational study enrolled 104 adult patients (≥18 years) with severe coma (Glasgow Coma Scale ≤8) requiring mechanical ventilation across three intensive care units in Tunisia.\n\nKey Features:\n\nAge/Sex: Mean age 47 years (range 18-80), 76% male\n\nPrimary Conditions:\n\nTraumatic brain injury (61%)\n\nHemorrhagic stroke (19%)\n\nOther neurological causes (20%)\n\nStudy Groups:\n\n26 patients (25%) progressed to brain death\n\n78 patients (75%) did not\n\nJustification:\n\nThe population represents typical severe coma cases in North African ICUs, with standardized brain death confirmation per national protocols (clinical exam + CT angiography).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults ≥18 years admitted to ICU with:\n\nSevere coma (Glasgow Coma Scale ≤8)\n\nRequiring mechanical ventilation\n\nPrimary diagnosis of:\n\nTraumatic brain injury (TBI)\n\nHemorrhagic stroke\n\nOther severe neurological conditions (anoxic brain injury, etc.)\n\nPotential organ donor status (for brain death subgroup):\n\nMeets clinical brain death criteria (absent brainstem reflexes, apnea)\n\nExclusion Criteria:\n\n* Non-neurological terminal conditions: e.g., Advanced cancer'}, 'identificationModule': {'nctId': 'NCT06948669', 'acronym': 'BDOD-TN', 'briefTitle': 'Brain Death and Organ Donation in Tunisian Intensive Care Units', 'organization': {'class': 'OTHER', 'fullName': 'Faculty of Medicine, Sousse'}, 'officialTitle': 'Predictors of Brain Death and Barriers to Organ Donation in a North African Intensive Care Units: A Multicenter Prospective Study on Severe Coma Patients', 'orgStudyIdInfo': {'id': 'BDOD-Tunisia-2022-2023'}, 'secondaryIdInfos': [{'id': 'HS13-2022', 'type': 'OTHER', 'domain': 'Sahloul University Hospital Research Ethics Committee'}]}, 'contactsLocationsModule': {'locations': [{'zip': '4002', 'city': 'Sousse', 'country': 'Tunisia', 'facility': 'Faculty of Medicine of Sousse, University of Sousse, Sousse, Tunisia', 'geoPoint': {'lat': 35.82539, 'lon': 10.63699}}], 'overallOfficials': [{'name': 'Imed Chouchene, MD Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Intensive Care Unit University Hospital of Farhat Hached Sousse Tunis Faculty of Medicine of Sousse'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No (but de-identified aggregate data will be published in the manuscript).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Faculty of Medicine, Sousse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Imen Slama', 'investigatorAffiliation': 'Faculty of Medicine, Sousse'}}}}