CompletedNot Applicable

Brain Death and Organ Donation in Tunisian Intensive Care Units

Tunisia104 participantsStarted 2022-11-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Brain death incidence

Timeframe: 0-12 months

Family donation refusal rate

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

Trial details

NCT IDNCT06948669

SponsorFaculty of Medicine, Sousse

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-11-01

View on ClinicalTrials.gov More Brain Injury trials