Post Traumatic Stress DisorderREPERPSYNCT03721770
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
An observational study of Post Traumatic Stress Disorder and Family, run by frederic ADNET at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post Traumatic Stress Disorder, Family, Psychological Distress
- How many people
- 37 participants
- Where
- 1 siteFrance
- Study dates
- 8 Oct 2015to 22 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Age < 18 years
- Refusal to participate in the study
- Difficulty in communication (foreign, language, etc)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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: an Observational, Prospective Study
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
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Psychological Assessment of Post Traumatic Stress Disorder Diagnosis and Major Depressive Episode Diagnosis.
Measured: 3 months et 1 year
Score of depression and anxiety (Hospital of Anxiety and Depression Scale).
Hospital of Anxiety and Depression Scale measures an anxio-depressive symptomatology and evaluates its severity. It does not try to distinguish different types of depression or anxiety states. This scale was constructed excluding any item concerning somatic aspects. Subscale anxiety (range score 0-21) and Subscale depression (range score 0-21). The thresholds for the sub scores are:
0-7 score = no anxiety disorder or depressive disorder; 8-10 = anxiety disorder or depressive disorder suspected; 11-21 = anxiety disorder or depressive disorder.
Range total score= 0-42. The thresholds for a total score are:
0-14 score= no anxiety or depressive disorder 15-42 score= existence of an anxiety or depressive disorder.
Measured: 3 months and 1 year
Score of pathological mourning (Inventory of Complicated Grief)
Inventory of Complicated Grief measures the symptoms of 'complicated grief'.The complicated grief is identified by the extended length of time of the symptoms, the interference in normal function caused by the symptoms, or by the intensity of the symptoms (for example, intense suicidal thoughts or acts).The complicated grief may appear as a complete absence of grief and mourning, an ongoing inability to experience normal grief reactions, delayed grief, conflicted grief, or chronic grief. Factors that contribute to the chance that one may experience complicated grief include the suddenness of the death, the gender of the person in mourning, and the relationship to the deceased.
Range total score= 0-88. Respondents with ICG scores greater than 25 are significantly more impaired in social, general, mental and physical health functioning and in bodily pain than those with ICG scores less than or equal to 25.
No subscales.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2018
- Study start8 Oct 2015
- Primary completion22 Jun 2018
- Study completion22 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- frederic ADNET
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, frederic ADNET, Association pour le Développement de la Recherche et de l'Enseignement en Médecine d'Urgence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03721770
- Sponsor's protocol ID
- LIC16160108
- Acronym
- REPERPSY
- Status last verified
- Oct 2018
- First submitted
- 25 Oct 2018
- Last updated
- 31 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 10580071Dominguez-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.
PubMed 21504489Fieux 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.
PubMed 19715564Eckenrod EL. Psychological/emotional trauma of donor families. Transplant Proc. 2008 May;40(4):1061-3. doi: 10.1016/j.transproceed.2008.03.048.
PubMed 18555115
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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: an Observational, Prospective Study
- ClinicalTrials.gov ID
- NCT03721770
- Acronym / sponsor ID
- REPERPSY / LIC16160108
- Conditions
- Post Traumatic Stress Disorder, Family, Psychological Distress, Organ and Tissue Procurement
- Keywords
- organ donation, family, Post Traumatic Stress Disorder, Bereavement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- frederic ADNETUniversity, hospital or other
- Study start
- 8 Oct 2015 (actual)
- Primary completion
- 22 Jun 2018 (actual)
- Study completion
- 22 Jun 2018 (actual)
- First posted
- 26 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- Age < 18 years
- Refusal to participate in the study
- Difficulty in communication (foreign, language, etc)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Score ≥ 33 on the Impact of Event Scale - Revised.
Time frame: 3 months
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 secondary outcomes
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)
Time frame: 3 months et 1 year
Score of depression and anxiety (Hospital of Anxiety and Depression Scale).
Time frame: 3 months and 1 year
Score of pathological mourning (Inventory of Complicated Grief)
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2018.
- Background: PubMed 10580071Wolfe 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.
- Background: PubMed 21504489Dominguez-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.
- Background: PubMed 19715564Fieux 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.
- Background: PubMed 18555115Eckenrod EL. Psychological/emotional trauma of donor families. Transplant Proc. 2008 May;40(4):1061-3. doi: 10.1016/j.transproceed.2008.03.048.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Traumatic Stress Disorder and Family, run by frederic ADNET at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score ≥ 33 on the Impact of Event Scale - Revised. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03721770, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2018.