An observational study in Brain Injury, Coma and Organ Transplants, sponsored by Faculty of Medicine, Sousse. Completed at 1 site in Tunisia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-29.
Sponsored by Faculty of Medicine, Sousse · Observational
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:
What medical factors (e.g., type of brain injury, ICU stay duration) increased the likelihood of progressing to brain death in these patients?
What patient characteristics (e.g., age, comorbidities) influenced the risk of brain death?
What were the reasons behind low organ donation rates in Tunisia, including family refusal and hospital-level barriers?
Participants were:
Adults with severe coma (Glasgow Coma Scale ≤ 8) requiring mechanical ventilation in Tunisian ICUs.
Data 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.
The study was conducted from November 2022 to November 2023 across three ICUs: Sahloul, Farhat Hached, and Mohamed Taher Maamouri Hospitals.
Background
Brain 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.
Objectives
This study aimed to:
Identify clinical predictors of brain death among critically ill patients with severe brain injuries
Explore reasons for organ donation refusal by families
Identify hospital-level barriers in the organ donation process
Study Design and Setting
This was a prospective observational cohort study conducted between November 2022 and November 2023 in three Tunisian intensive care units:
Sahloul University Hospital (trauma center)
Farhat Hached University Hospital
Mohamed Taher Maamouri Hospital
Participants
Adult 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.
Procedures Data Collection
Data 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).
The collected variables included:
Demographic information (e.g., age, sex)
Clinical characteristics (e.g., Glasgow Coma Scale on ICU admission, comorbidities, primary diagnosis)
Patient outcomes (e.g., progression to brain death, ICU discharge, or death from other causes)
Length of ICU stay
Organ donation process variables (e.g., whether families were approached, family consent or refusal, organ procurement, reasons for refusal)
Family approaches were conducted by the national transplant coordination team from the CNPTO.
No experimental interventions were applied. All procedures were part of standard ICU care.
946 studies on the registry are indexed under Brain Injuries; 235 are open to participants now.
This study's enrollment of 104 is close to the median of 100 across 302 observational studies indexed under Brain Injuries.
Browse Brain Injuries studies →Faculty of Medicine, Sousse is the lead sponsor of 23 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Key Features:
Age/Sex: Mean age 47 years (range 18-80), 76% male
Primary Conditions:
Traumatic brain injury (61%)
Hemorrhagic stroke (19%)
Other neurological causes (20%)
Study Groups:
26 patients (25%) progressed to brain death
78 patients (75%) did not
Justification:
The population represents typical severe coma cases in North African ICUs, with standardized brain death confirmation per national protocols (clinical exam + CT angiography).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Severe coma (Glasgow Coma Scale ≤8)
Requiring mechanical ventilation
Primary diagnosis of:
Traumatic brain injury (TBI)
Hemorrhagic stroke
Other severe neurological conditions (anoxic brain injury, etc.)
Potential organ donor status (for brain death subgroup):
Meets clinical brain death criteria (absent brainstem reflexes, apnea)
Exclusion Criteria:
Brain death incidence
Proportion of patients progressing to brain death (clinical + CT angiography).
Time frame: 0-12 months
Family donation refusal rate
Percentage of families declining organ donation, with reasons
Time frame: At time of brain death confirmation (through study completion, an average of 1 year)
Multivariate analysis of brain death predictors
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
Time frame: From ICU admission to outcome determination (up to 1 year)
Plan to share: No — No (but de-identified aggregate data will be published in the manuscript).
No publications or documents are linked to this record.
Ran from Nov 2022 to primary completion in Nov 2023, 12 months.
Of 143 non-industry observational studies under Brain Injuries, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 73. This study's 12 months is below that.
Counting every sponsor, half of 148 studies reached it within 31 months; a quarter within 16 and three quarters within 73.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Faculty of Medicine, Sousse