The Anticipated Organ Donation Approach (PREMORENCE)

Intermunicipal Hospital Center Toulon

Status: Completed

Conditions: Brain Death

Study type: Observational

Funder types: Other

Identifiers

NCT03765814

2018-A01455-50 (Other Identifier)

2018-CHITS-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 83 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)