Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-31 @ 4:38 AM
Study NCT ID:
NCT06948669
Status:
COMPLETED
Last Update Posted:
2025-04-29
First Post:
2025-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brain Death and Organ Donation in Tunisian Intensive Care Units
Sponsor:
Faculty of Medicine, Sousse
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BDOD-TN
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| HS13-2022 | OTHER | Sahloul University Hospital Research Ethics Committee | View |