The Anticipated Organ Donation Approach (PREMORENCE)

Paramedical Evaluation of a Standardize Procedure of Selection of Serious Brain-injured Patients in Therapeutic Abstention to a Brain Death State in the First 48h

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.

Study Overview

• Status: Recruiting
• Conditions: Brain Death

Detailed Description

In 2016 in France, 5891 organs have been transplanted. All the transplant's sources are developed (brain death, Maastricht III, living organ donor).

However, the French Transplant's plan 2017-2021 require always more transplant, the aim is to reach 7800 transplants in 4 years.

To increase the number of transplants, one of the strategies is to actively identify the donors in brain death state and the donors with wider criteria. It's mainly serious brain-injured patients.

The procedure of early announcement of organ donation consists in beginning or pursues intensive care on serious brain-injured patient, for whom a decision of abstention of therapeutic active was decided. The only purpose of the medical care is to notice the brain death state that lead to donation.

In 2010, an expert group of the "Société de reanimation de langue Française" established guidelines to manage organ's donation in serious brain-injured patient after a stroke. The interest, to admit these serious brain-injured patients in intensive care unit, is to increase the number of donors in state of brain death and so the number of transplants.

However the guidelines remain little practised and little known in France. The number of bed in intensive care unit is limited and requires a selection of the potential organ donors. To hospitalised serious brain-injured patients in intensive care unit, there are no validated selection criteria that make difficult the implication of the transplant coordination in this anticipated announcement's approach.

In Toulon hospital, a standardize selection procedure was initiated and applied systematically by the transplant coordinator for each serious brain-injured patients. The selected patients will evolve in brain death state in 48 hours and could be organ donors.

The aim of this study is to validate a paramedical procedure to increase the number of organ donors.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Asmaa Jobic; Phone Number: +33 04.83.77.20.61; Email: asmaa.jobic@ch-toulon.fr

Study Locations

• France
  • Haute Savoie
    • Pringy, Haute Savoie, France, 74374
      • Recruiting
      • CH Annecy Genevois
      • Contact: Marie Lebouc; Phone Number: +33 0450637133; Email: mlebouc@ch-annecygenevois.fr
      • Principal Investigator: Didier Dorez, MD
  • Loire-Atlantique
    • Nantes, Loire-Atlantique, France, 44093
      • Recruiting
      • CHU de Nantes
      • Contact: Marie-Laurence Saulnier, Nurse; Phone Number: +33 02 53 48 22 45; Email: marielaurence.saulnier@chu-nantes.fr
      • Principal Investigator: Laurent Martin-Lefèvre, MD
  • Var
    • Toulon, Var, France, 83200
      • Recruiting
      • Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
      • Contact: Blaisine Bayard, Nurse; Phone Number: +33 0494145063; Email: blaisine.bayard@ch-toulon.fr
  • Vendée
    • La Roche-sur-Yon, Vendée, France, 85000
      • Recruiting
      • Centre Hospitalier Départemental de Vendée Les Oudairies
      • Principal Investigator: Laurent Martin-Lefèvre, MD
      • Contact: Natacha Maquigneau, Nurse; Phone Number: +33 0251446026; Email: natacha.maquigneau@ght85.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Seriously brain-injured patient with therapeutic abstention

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of transplants performed.	The number of transplants performed will be presented globally, by patient and by type of organs.	10 days
Non harvested organs which have been suggested for transplant	The proportion of suggested non harvested organs will be determined as the number of suggested non harvested organs divided by the total number of non harvested organs. Reasons of suggested organs refusal will be presented.	10 days
Number of patients who performed Maastricht 3 organ donation among patients who didn't evolve to brain death state	The rate of patients with Maastricht 3 organ donation will be determined as the number of patients having performed Maastricht 3 organ donation divided by the number of patients who didn't evolve to brain death state after 48hours	10 days
Evaluation of call rate to transplant coordination that don't result in a procedure of anticipated announcement	Ratio between the number of non-eligible patients and the total number of calls	48 hours after validation of eligibility
Evaluation of close family refusal rate for pursuit of care during 48h in intensive care unit	Ratio between the number of family refusal and the total number of patients for whom the anticipated announcement procedure was started.	48 hours after validation of eligibility
Number of refusal causes in the population	Number of refusal causes will be presented globally	48 hours after validation of eligibility
Evaluation of the delay between eligibility validation and the passage in brain death state.	The passage delay between eligibility validation and brain death state is defined by the time in hours between the examination which validates patient's eligibility and the diagnosis of brain death state.	48 hours after validation of eligibility
Evaluation of the rate of patients with organ removal in enrolled patients.	Ratio between the number of patient who performed organ donation and the total number of patients included.	48 hours after validation of eligibility
Number and type of organ harvested by patient.	Number of organs collected will be presented globally, by patient and by type of organ transplanted.	48 hours after validation of eligibility
Number of patient enrolled by type of service.	The number of patient enrolled in the intensive care unit, the Emergency or Neurovascular intensive care unit will be described globally	48 hours after validation of eligibility

Collaborators and Investigators

• Sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
• Collaborators: Centre Hospitalier Universitaire de Nice
• Investigators: Study Director: Valérie Arsonneau, Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2019
• Primary Completion (Estimated): September 28, 2024
• Study Completion (Estimated): September 28, 2024

Study Registration Dates

• First Submitted: November 22, 2018
• First Submitted That Met QC Criteria: December 4, 2018
• First Posted (Actual): December 5, 2018

Study Record Updates

• Last Update Posted (Actual): April 1, 2024
• Last Update Submitted That Met QC Criteria: March 29, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: organ donation; serious brain-injured patient; anticipated approach
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Unconsciousness; Consciousness Disorders; Coma; Death; Brain Death
• Other Study ID Numbers: 2018-CHITS-02; 2018-A01455-50 (Other Identifier: Id-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: no plan

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No