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FABRA-study.

Family presence during brain death determination.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON21921
Enrollment
240
Registered
2009-06-29
Start date
2009-09-01
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

brain death organ donation family refusal --------------- hersendood orgaandonatie familieweigering

Interventions

To offer family members the opportunity to experience and observe the examinations that are essential for the determination of brain death (with exception of the electroencephalography).

Sponsors

Erasmus MC Intensive Care Rotterdam Chair: Prof. dr. J. Bakker
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. A suspicion of a brain death patient on a intensive care unit of one of the participating hospitals (patient satifies the preliminary conditions of the brain death protocol. Glasgow coma scale of 3, more than 1 absent brainstem reflex and mechanical ventilation); 2. Qualifies for postmortal organ donation with respect to age and the medical condition; 3. Direct relatives are present on the ICu (18 years or older).

Exclusion criteria

Exclusion criteria: 1. Patient does not satisfy the preliminary conditions as for postmortal hearbeating organ donation; 2. Does not qualify for postmortal organ donation medically or with respect to age; 3. No direct relatives of the patient present on the ICU; 4. Refusal of the patient for organ donation as declared in the "Donorregister" by the patient.

Design outcomes

Primary

MeasureTime frame
The rate of consent or refusal for organ donation by close family members of a potential brain death patient, who were present during brain death determination.

Secondary

MeasureTime frame
Understanding of the concept of brain death by family members of patients with severe irreversible neurological damage.

Contacts

Public ContactE.J.O Kompanje

Postbus 2040

e.j.o.kompanje@erasmusmc.nl0031-6-53837655

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)