Brain InjuryBDOD-TNNCT06948669
Brain Death and Organ Donation in Tunisian Intensive Care Units
An observational study of Brain Injury and Coma, run by Faculty of Medicine, Sousse at 1 site in Tunisia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Injury, Coma, Organ Transplants
- How many people
- 104 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Nov 2022to 25 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
Show all 9Show fewer
- 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)
Who cannot join
- Non-neurological terminal conditions: e.g., Advanced cancer
Trial locations and contacts
1 site in 1 country.
Tunisia1 site
Faculty of Medicine of Sousse, University of Sousse, Sousse, Tunisia
Sousse, 4002
About this study
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
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?
Read more
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.
Read the 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.
- Conditions
- Brain Injury, Coma, Organ Transplants
- Keywords
- Organ donation refusal, ICU donor management, Cultural barriers, Hemorrhagic stroke outcome
- Medical subject headings
- Brain Injuries, Coma
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain death incidence
Proportion of patients progressing to brain death (clinical + CT angiography).
Measured: 0-12 months
Family donation refusal rate
Percentage of families declining organ donation, with reasons
Measured: At time of brain death confirmation (through study completion, an average of 1 year)
Secondary outcomes (1)
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
Measured: From ICU admission to outcome determination (up to 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2025
- Study start1 Nov 2022
- Primary completion1 Nov 2023
- Study completion25 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculty of Medicine, Sousse
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Imen Slama, Faculty of Medicine, Sousse
- Investigators
- Imed Chouchene, MD Professor, Study director, Intensive Care Unit University Hospital of Farhat Hached Sousse Tunis Faculty of Medicine of Sousse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06948669
- Sponsor's protocol ID
- BDOD-Tunisia-2022-2023
- Other IDs
- HS13-2022
- Acronym
- BDOD-TN
- Status last verified
- Apr 2025
- First submitted
- 11 Apr 2025
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No (but de-identified aggregate data will be published in the manuscript).
Publications
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.
PubMed 40794438
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06948669
- Acronym / sponsor ID
- BDOD-TN / BDOD-Tunisia-2022-2023
- Conditions
- Brain Injury, Coma, Organ Transplants
- Keywords
- Organ donation refusal, ICU donor management, Cultural barriers, Hemorrhagic stroke outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Faculty of Medicine, SousseUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 25 Nov 2023 (actual)
- First posted
- 29 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (9 listed)
- Adults ≥18 years admitted to ICU with:
- Severe coma (Glasgow Coma Scale ≤8)
- Requiring mechanical ventilation
- Traumatic brain injury (TBI)
- Hemorrhagic stroke
Key exclusion criteria (1 listed)
- Non-neurological terminal conditions: e.g., Advanced cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Brain death incidence
Time frame: 0-12 months
Proportion of patients progressing to brain death (clinical + CT angiography).
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
1 secondary outcome
Multivariate analysis of brain death predictors
Time frame: From ICU admission to outcome determination (up to 1 year)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
- Derived from this study: PubMed 40794438Slama 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.
- Individual participant dataSharing planned: No. No (but de-identified aggregate data will be published in the manuscript).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Imed Chouchene, MD Professor study director
Intensive Care Unit University Hospital of Farhat Hached Sousse Tunis Faculty of Medicine of Sousse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Injury and Coma, run by Faculty of Medicine, Sousse at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain death incidence (time frame: 0-12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06948669, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025.