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Psychological Impact in a Relative, Following the Announcement of the Death of a Loved One After Cardiac Arrest and the Early Request for Organ Donation (REPERPSY)

F

frederic ADNET

Status

Completed

Conditions

Organ and Tissue Procurement
Post Traumatic Stress Disorder
Family
Psychological Distress

Study type

Observational

Funder types

Other

Identifiers

NCT03721770
LIC16160108

Details and patient eligibility

About

The fight against the scarcity of grafts is a major public health issue in France. Despite a very good success rate of transplants from brain-dead donors or living donors, the waiting time for transplantation continues to increase, leading to morbidity and mortality, as well as medical costs. Since 2005, the BioMedicine Agency has implemented a protocol authorizing kidney and liver samples taken from deceased donors after cardiac arrest (DDAC). This type of sampling has become a common practice in several regions of France and Europe. In case of DDAC, the sampling protocol poses a significant temporal constraint, since the patient must be taken within 6 hours after the cardiac arrest. This constraint leads to a specific organization of the announcement of the death and the request for non-opposition to the levy.

The brutal loss of a loved one is a potentially traumatic experience for family members. The manifestations of the pathological components of mourning such as post-traumatic stress disorder, anxio-depressive syndrome, pathological bereavement, are often expressed early in the first year after the death of the loved one. Families of organ donor patients probably represent a population at high risk for the expression of psychiatric conditions such as post-traumatic stress disorder or pathological bereavement. The limited time available to prepare relatives to make a decision could promote the expression of psychiatric morbidity in the short or medium term. The data on this new transplantation procedure and its psychological consequences are insufficient, and we consider that if a state of post-traumatic stress occurred in more than 50% of parents, the procedure of announcement would be reviewed. The purpose of this study is to test this hypothesis.

Most of the work on relatives of potential organ donors has focused on procedures for brain death. Most of this work has focused on characterizing the determinants of acceptance or refusal of organ donation in the family. The literature relating to the follow-up of relatives of a patient after organ donation is very poor: very few studies have focused on the psychological consequences and / or the psychological state of this population in the period post-death. In addition, very few qualitative and quantitative studies make it possible to evaluate the appearance of psychopathological manifestations related to the announcement of death simultaneously with a request for organ removal. This research, therefore, will make it possible to estimate the possible psychological impact on the bereaved family as well as an assessment of the psychological state. A mixed methodology (quantitative and qualitative) will make it possible to highlight explanatory factors of the quantitative results.

Enrollment

37 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Parent or adult companion of a patient who died of cardiac arrest after organ removal (Inclusion order of priority is husband-wife / father-mother / son-daughter)
  • Only one loved one is included per patient.

Exclusion criteria

  • Age < 18 years
  • Refusal to participate in the study
  • Difficulty in communication (foreign, language, etc)

Trial design

37 participants in 1 patient group

Relatives
Description:
Relative or adult companion (age \<18 years) of a patient who died of cardiac arrest after organ removal request. A parent is defined as a close relative of the first degree: husband-wife, father-mother, son-daughter. Only one loved one is included per patient. Inclusion order of priority is husband-wife / father-mother / son-daughter.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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