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New procedure could speed up organ donor identification in brain injury patients

NCT ID NCT03765814

Knowledge-focused Sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 08, 2026 · Updated 2 times

Summary

This completed study tested a standard way to select seriously brain-injured patients who might become brain dead within 48 hours. Researchers tracked 83 patients in intensive care to see how many progressed to brain death. The goal was to improve the process for organ donation coordination.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could improve how hospitals identify potential organ donors among brain-injured patients, possibly increasing organ availability.
What could go wrong
This is an observational study, not a treatment trial. It does not test a new therapy, so it cannot directly help patients. Results may not apply to all hospitals or regions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

83 people

The number who actually took part.

Started

Sep 2019

Finished

Oct 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Seriously brain-injured patient with therapeutic abstention

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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, Creutzfeldt-Jakob disease)

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Conditions

The condition(s) this trial relates to.

Brain Death brain injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Brain death

Contacts and locations

Locations

  • CH Annecy Genevois

    Pringy, Haute Savoie, 74374, France

  • CHU de Nantes

    Nantes, Loire-Atlantique, 44093, France

  • Centre Hospitalier Départemental de Vendée Les Oudairies

    La Roche-sur-Yon, Vendée, 85000, France

  • Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

    Toulon, Var, 83200, France

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