Organ Procurement : Usefulness of a Guide for Meeting With the Next of Kin

NCT02854267 | Completed

• 1 other identifier: CANEVAS
• Study Type: observational
• Target: 322
• Locations: 1 country
• Sites: 1

Brief Summary

A dedicated guide for physicians and organ procurement nurses meeting with the next of kin could be associated with a reduction in organ donation refusal rate, and in anxiety of professionals involved in such meetings

Conditions

Organ Donation

Keywords

organ procurement; brain death; organ donation; next of kins

Outcome Measures

Primary Outcomes (1)

• Refusal to organ procurement as expressed by next of kins

  Assessed in the national biomedicine agency database retrospectively over a 2-years period before diffusion of a dedicated guide for meeting, and prospectively over a 2 years period after the diffusion of a dedicated guide for meeting

  2 years

Secondary Outcomes (2)

• Anxiety level of caregivers after meeting with the next of kins

  2 years

• Compliance to the guide

  2 years

Study Arms (4)

group without guide, before guide's diffusion

For this group, only the primary endpoint (refusal rate) will be assessed, using the French Biomedicine Agency database; The group without guide is made up by all registered situations of brain death patients on the database (nationwide) minus the situations occuring in the group with guide (22 intensive care units forming the 'RESEAU NORD FRANCILIEN' network). The period before the diffusion of the guide is from 1st of july 2012 to 30th of june 2014

group without guide, after guide's diffusion

For this group, only the primary objective (refusal rate) will be assessed, using the French Biomedicine Agency database; The group without guide is made up by all the registered situations of brain death patients on the database minus the situations occuring in the group with guide ('RESEAU NORD FRANCILIEN'). The period after the diffusion of the guide is from 1st of january 2017 to 31st of december 2018

Group with guide, before guide's diffusion

For this group, only the primary endpoint (refusal rate) will be assessed, using the French Biomedicine Agency database; The group with guide is made up by all the registered situations of brain death patients on the database occuring in the 22 intensive care unit forming the 'RESEAU NORD FRANCILIEN' network. The period after the diffusion of the guide is from 1st of january 2017 to 31st of december 2018.

Group with guide, after guide's diffusion

For this group, the primary endpoint (refusal rate) will be assessed, using the French Biomedicine Agency database. The secondary endpoints (level of anxiety of the caregivers before the meeting with the next of kins as measured by the french short version of Spielberger test and compliance to the guide) will be assessed by the datasheet prospectively filled by the caregivers. The group with guide is made up by all the registered situations of brain death patients on the database occuring in the 22 intensive care unit forming the 'RESEAU NORD FRANCILIEN' network. The period after the diffusion of the guide is from 1st of january 2017 to 31st of december 2018

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Interviews with next of kins as a part of organ donation

You may qualify if:

• situation of confirmed brain dead patient, or dead patient with pending confirmation of brain death

You may not qualify if:

• situations where the next of kins are met before brain death

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hopital Beaujon

Clichy, 92110, 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

• Stanislas Kandelman, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 31, 2016
• First Posted: August 3, 2016
• Study Start: January 1, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: January 28, 2020

Record last verified: 2020-01

Locations

FR (1)