Brain Death and Organ Donation in Tunisian Intensive Care Units

NCT06948669 | Completed

• 2 other identifiers: BDOD-Tunisia-2022-2023HS13-2022
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Brain Injury; Coma; Organ Transplants

Keywords

Organ donation refusal; ICU donor management; Cultural barriers; Hemorrhagic stroke outcome

Outcome Measures

Primary Outcomes (2)

• Brain death incidence

  Proportion of patients progressing to brain death (clinical + CT angiography).

  0-12 months

• Family donation refusal rate

  Percentage of families declining organ donation, with reasons

  At time of brain death confirmation (through study completion, an average of 1 year)

Secondary Outcomes (1)

• Multivariate analysis of brain death predictors

  From ICU admission to outcome determination (up to 1 year)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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).

You may qualify if:

• Adults ≥18 years admitted to ICU with:
• 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)

You may not qualify if:

• Non-neurological terminal conditions: e.g., Advanced cancer

Sponsors & Collaborators

• Faculty of Medicine, Sousse: lead

Study Sites (1)

Faculty of Medicine of Sousse, University of Sousse, Sousse, Tunisia

Sousse, 4002, Tunisia

Location

Related Publications (1)

• 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.

  PMID: 40794438 DERIVED

MeSH Terms

Conditions

Brain Injuries; Coma

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Imed Chouchene, MD Professor

  Intensive Care Unit University Hospital of Farhat Hached Sousse Tunis Faculty of Medicine of Sousse

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: April 29, 2025
• Study Start: November 1, 2022
• Primary Completion: November 1, 2023
• Study Completion: November 25, 2023
• Last Updated: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)