Clinical trial NCT06948669: Brain Death and Organ Donation in Tunisian Intensive Care Units
Official title: Predictors of Brain Death and Barriers to Organ Donation in a North African Intensive Care Units: A Multicenter Prospective Study on Severe Coma Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Injury
Coma
Organ Transplants
Keywords: Organ donation refusal
ICU donor management
Cultural barriers
Hemorrhagic stroke outcome
Lead sponsor: Faculty of Medicine, Sousse
Sponsor class: OTHER
First posted: 2025-04-29
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Brain death incidence
timeFrame: 0-12 months
measure: Family donation refusal rate
timeFrame: At time of brain death confirmation (through study completion, an average of 1 year)
Secondary outcomes:
measure: Multivariate analysis of brain death predictors
timeFrame: From ICU admission to outcome determination (up to 1 year)
Other outcomes:
Locations:
city: Sousse
country: Tunisia
facility: Faculty of Medicine of Sousse, University of Sousse, Sousse, Tunisia
Study officials:
affiliation: Intensive Care Unit University Hospital of Farhat Hached Sousse Tunis Faculty of Medicine of Sousse
name: Imed Chouchene, MD Professor
role: STUDY_DIRECTOR
References: