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

NCT03721770 | Completed

• 1 other identifier: LIC16160108
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post Traumatic Stress Disorder; Family; Psychological Distress; Organ and Tissue Procurement

Keywords

organ donation; family; Post Traumatic Stress Disorder; Bereavement

Outcome Measures

Primary Outcomes (1)

• Score ≥ 33 on the Impact of Event Scale - Revised.

  Percentage of relatives with post-traumatic stress disorder at 3 months with a score ≥ 33 on the Impact of Event Scale - Revised. The Impact of Event Scale - Revised measures symptoms of intrusion, avoidance, numbing and hyperarousal with respect to a particular life-threatening event. Subscales of the scale: Intrusion scale (range 0-24 score); avoidance scale (range 0-26 score); hyperarousal scale (range 0-18 score. Range of the scale 0-88 scores. Score 24 and more: PTSD is a clinical concern. Score 33 and above : This represents the best cutoff for a probable diagnosis of PTSD Score 37 and more : This is high enough to suppress the immune system's functioning (even 10 years after an impact event).

  3 months

Secondary Outcomes (3)

• Post Traumatic Stress Disorder Diagnosis And Major Depressive Episode Diagnosis (Mini International Neuropsychiatric Interview - Version 5.0.0 Module I. Post Traumatic Stress Disorder and Module A. Major Depressive Episode)

  3 months et 1 year

• Score of depression and anxiety (Hospital of Anxiety and Depression Scale).

  3 months and 1 year

• Score of pathological mourning (Inventory of Complicated Grief)

  1 year

Study Arms (1)

Relatives

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The relatives will be recruited during the interview with the coordination team of organs and tissues, after acceptance or refusal of organ donation.

You may qualify if:

• Only one loved one is included per patient.

You may not qualify if:

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

Sponsors & Collaborators

• frederic ADNET: lead

Study Sites (1)

ADNET Frederic

Bobigny, 93000, France

Location

Related Publications (4)

• Wolfe RA, Ashby VB, Milford EL, Ojo AO, Ettenger RE, Agodoa LY, Held PJ, Port FK. Comparison of mortality in all patients on dialysis, patients on dialysis awaiting transplantation, and recipients of a first cadaveric transplant. N Engl J Med. 1999 Dec 2;341(23):1725-30. doi: 10.1056/NEJM199912023412303.

  PMID: 10580071 BACKGROUND

• Dominguez-Gil B, Haase-Kromwijk B, Van Leiden H, Neuberger J, Coene L, Morel P, Corinne A, Muehlbacher F, Brezovsky P, Costa AN, Rozental R, Matesanz R; European Committee (Partial Agreement) on Organ Transplantation. Council of Europe (CD-P-TO). Current situation of donation after circulatory death in European countries. Transpl Int. 2011 Jul;24(7):676-86. doi: 10.1111/j.1432-2277.2011.01257.x. Epub 2011 Apr 19.

  PMID: 21504489 BACKGROUND

• Fieux F, Losser MR, Bourgeois E, Bonnet F, Marie O, Gaudez F, Abboud I, Donay JL, Roussin F, Mourey F, Adnet F, Jacob L. Kidney retrieval after sudden out of hospital refractory cardiac arrest: a cohort of uncontrolled non heart beating donors. Crit Care. 2009;13(4):R141. doi: 10.1186/cc8022. Epub 2009 Aug 28.

  PMID: 19715564 BACKGROUND

• Eckenrod EL. Psychological/emotional trauma of donor families. Transplant Proc. 2008 May;40(4):1061-3. doi: 10.1016/j.transproceed.2008.03.048.

  PMID: 18555115 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: October 25, 2018
• First Posted: October 26, 2018
• Study Start: October 8, 2015
• Primary Completion: June 22, 2018
• Study Completion: June 22, 2018
• Last Updated: October 31, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)