NCT06948669Completed
Brain Death and Organ Donation in Tunisian Intensive Care Units
Predictors of Brain Death and Barriers to Organ Donation in a North African Intensive Care Units: A Multicenter Prospective Study on Severe Coma Patients
Source: ClinicalTrials.gov · Last updated 29 Apr 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 104 (actual)
- First submitted
- 11 Apr 2025
- Start date
- 1 Nov 2022
- Primary completion date
- 1 Nov 2023
- Lead sponsor
- Faculty of Medicine, Sousse
- Diseases
- Stroke
- NCT number
- NCT06948669
What you commit to
- Study type: Observational
- Participants enrolled: 104
- From 1 Nov 2022 to the primary completion date, 1 Nov 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Non-neurological terminal conditions: e.g., Advanced cancer
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Faculty of Medicine of Sousse, University of Sousse, Sousse, Tunisia Coordinator of this site? Confirm its status | Sousse | Tunisia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.