The Anticipated Organ Donation Approach

NCT03765814 | Completed

• 2 other identifiers: 2018-CHITS-022018-A01455-50
• Study Type: observational
• Target: 83
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Brain Death

Keywords

organ donation; serious brain-injured patient; anticipated approach

Outcome Measures

Primary Outcomes (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.

  Rate of patients evolving to brain death state during the first 48 hours following the examination which validates patient's eligibility

  48 hours after validation of eligibility

Secondary Outcomes (10)

• Evaluation of call rate to transplant coordination that don't result in a procedure of anticipated announcement

  48 hours after validation of eligibility

• Evaluation of close family refusal rate for pursuit of care during 48h in intensive care unit

  48 hours after validation of eligibility

• Number of refusal causes in the population

  48 hours after validation of eligibility

• Evaluation of the delay between eligibility validation and the passage in brain death state.

  48 hours after validation of eligibility

• Evaluation of the rate of patients with organ removal in enrolled patients.

  48 hours after validation of eligibility

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Seriously brain-injured patient with therapeutic abstention

You may qualify if:

• 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

You may not qualify if:

• No trusted person or family present
• Seriously brain-injured patient because of head trauma, brain anoxia or ischemic stroke with confounding factors

Sponsors & Collaborators

• Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer: lead
• Centre Hospitalier Universitaire de Nice: collaborator

Study Sites (4)

CH Annecy Genevois

Pringy, Haute Savoie, 74374, France

Location

CHU de Nantes

Nantes, Loire-Atlantique, 44093, France

Location

Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

Toulon, Var, 83200, France

Location

Centre Hospitalier Départemental de Vendée Les Oudairies

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

Location

MeSH Terms

Conditions

Brain Death

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Coma; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Valérie Arsonneau

  Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2018
• First Posted: December 5, 2018
• Study Start: September 29, 2019
• Primary Completion: September 23, 2024
• Study Completion: October 3, 2024
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)