The Anticipated Organ Donation Approach (NCT03765814) | Clinical Trial Compass
CompletedNot Applicable
The Anticipated Organ Donation Approach
France83 participantsStarted 2019-09-29
Plain-language summary
The purpose of this study is to make a paramedical evaluation of a selection procedure of serious brain-injured patient in therapeutic abstention to a brain death state within 48 hours.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Male or Female over 18 years-old
* Patient with serious brain damages
* Medical decision of withdrawing life sustaining treatment
* Signed and dated informed consent by trusted person, or family
* Patient covered by social security regimen
* Patient eligible for organ donation according to organ donation hospital co-ordination
* Glasgow Coma Scale (GCS) :
* Seriously brain-injured patient without confounding factors, head trauma, brain anoxia or ischemic stroke : GCS\<5 and loss of bilateral corneal reflex or GCS\<5 and loss of three brain stem reflexes
* Seriously brain-injured patient with confounding factors and without head trauma, brain anoxia or ischemic stroke : at least one of the following scanographic sign of gravity : deletion of subarachnoid cisterns, more than 15 mm deviation of the median line, hematoma volume \> 65 cm3 or hydrocephalus due to intra-ventricular bleeding with V3 or V4 flood, and, if documented, a GCS\<7.
* Patient with head trauma, brain anoxia or ischemic stroke, reliable clinical examination required (no confounding factor) : GCS\<5 and loss of bilateral corneal reflex or GCS\<5 and loss of three brain stem reflexes
Exclusion Criteria:
* No trusted person or family present
* Seriously brain-injured patient because of head trauma, brain anoxia or ischemic stroke with confounding factors
* Absolute contraindication to organ donation known at the moment of inclusion (HIV, rabies, active cancer, active tuberculosis, ā¦
What they're measuring
1
Study of the evolution to brain death state within 48 hours of seriously brain-injured patients selected by a standardized procedure and hospitalised in intensive care unit.
Timeframe: 48 hours after validation of eligibility
Trial details
NCT IDNCT03765814
SponsorCentre Hospitalier Intercommunal de Toulon La Seyne sur Mer