Brain Death and Organ Donation in Tunisian Intensive Care Units (BDOD-TN)

Predictors of Brain Death and Barriers to Organ Donation in a North African Intensive Care Units: A Multicenter Prospective Study on Severe Coma Patients

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.

Study Overview

• Status: Completed
• Conditions: Brain Injury; Coma; Organ Transplants

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 104

Contacts and Locations

Study Locations

• Tunisia
  • Sousse, Tunisia, 4002
    • Faculty of Medicine of Sousse, University of Sousse, Sousse, Tunisia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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).

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	From ICU admission to outcome determination (up to 1 year)

Collaborators and Investigators

• Sponsor: Faculty of Medicine, Sousse
• Investigators: Study Director: Imed Chouchene, MD Professor, Intensive Care Unit University Hospital of Farhat Hached Sousse Tunis Faculty of Medicine of Sousse

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Actual): November 1, 2023
• Study Completion (Actual): November 25, 2023

Study Registration Dates

• First Submitted: April 11, 2025
• First Submitted That Met QC Criteria: April 24, 2025
• First Posted (Actual): April 29, 2025

Study Record Updates

• Last Update Posted (Actual): April 29, 2025
• Last Update Submitted That Met QC Criteria: April 24, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Organ donation refusal; ICU donor management; Cultural barriers; Hemorrhagic stroke outcome
• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Pathologic Processes; Neurobehavioral Manifestations; Death; Craniocerebral Trauma; Trauma, Nervous System; Consciousness Disorders; Unconsciousness; Coma; Brain Injuries; Brain Death
• Other Study ID Numbers: BDOD-Tunisia-2022-2023; HS13-2022 (Other Identifier: Sahloul University Hospital Research Ethics Committee)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No (but de-identified aggregate data will be published in the manuscript).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No