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Completed

NCT Number: NCT06948669

Brain Death and Organ Donation in Tunisian Intensive Care Units

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Brain death incidence

    Time frame: 0-12 months

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

  2. Family donation refusal rate

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

    Percentage of families declining organ donation, with reasons

Secondary outcomes

  1. Multivariate analysis of brain death predictors

    Time frame: From ICU admission to outcome determination (up to 1 year)

    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

Sponsors and collaborators

Lead sponsor

Faculty of Medicine, Sousse

Other

Registry information

Official study 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

Acronym: BDOD-TN

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 29, 2025
Registry last updated
Apr 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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