Death, AssistedCARE-M3NCT05041023
Experience of Relatives and Intensive Care Units Caregivers of Controlled Donation After Circulatory Death
An observational study of Death, Assisted and Tissue and Organ Procurement, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Controlled donation after circulatory death (cDCD) refers to organ donation (OD) from patients whose death is defined using circulatory criteria and from whom circulatory death occurs after a planned withdrawal of life-sustaining therapies (WLST) in intensive care units (ICUs). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Death, Assisted, Tissue and Organ Procurement, Life Support Care
- What is being tested?
- Relative section and Caregiver section
- How many people
- 367 participants
- Where
- 1 siteFrance
- Study dates
- 27 Oct 2021to 13 Sep 2024
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The relatives of patients who have died in ICU are the first attendant of the patient at the end-of-life EOL. During this procedure, relatives are particularly solicited because they are strongly involved in the decision-making process. The most involved relative in the relationship with the resuscitation team will be asked to participate in the study. Caregivers included in the study are caregivers from ICU who are present at the time the withdrawal of life-sustaining therapies WLST is initiated: at least 1 physician and 1 or 2 paramedics.
Who may be able to join
- Any situation of anticipated death of a patient in Intensive Care Unit ICU due to circulatory arrest:
- For which a decision to withdraw Life-Sustaining Therapies LST was taken under the Claeys-Leonetti law, notified to relatives and accepted by relatives
- With a first evaluation by the hospital coordination of organ and tissue removal identifying the patient at the end of life as a potential donor: patient identified under the age of 70, with no absolute contraindication to organ removal in the context of an M3 procedure
- For which Organ Donation OD has been discussed with the relatives, whether the OD finally occurred.
- Relative and/or caregiver who has given non-objection to the use of the data.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
France1 site
APHP - Lariboisière hospital - réanimation chirurgicale
Paris, 75010
About this study
Official title: Experience of Relatives and Caregivers of Death in ICU After the Withdrawal of Life-sustaining Therapies, Associated With an Organ Procurement Procedure (Controlled Donation After Circulatory Death).
Controlled donation after circulatory death (cDCD) refers to organ donation (OD) from patients whose death is defined using circulatory criteria and from whom circulatory death occurs after a planned withdrawal of life-sustaining therapies (WLST) in intensive care units (ICUs). During cDCD, the patient is still alive while OD process is being discussed and organized. Caregivers can be particularly uncomfortable in this scenario. In the specific context of cDCD, developing knowledge on the perceptions and experiences of relatives and ICU caregivers regarding OD is crucial but remains poorly investigated.
Investigators propose to conduct a prospective multicentric observational research to better understand relatives' and ICU caregivers' experience of cDCD. Better understanding their perceptions and experiences will enable to develop interventions to support and guide them throughout this practice.
Read the detailed description
While withdrawal of life-sustaining therapies (WLST) decision occur significantly more frequently in intensive care units (ICUs), controlled donation after circulatory death (cDCD) evolves end-of-life care and produces a new end-of-life (EOL) model: EOL care now includes the opportunity to donate organs and tissues after death. During cDCD, the patient is still alive while OD process is being discussed and organized. Caregivers can be particularly uncomfortable in this scenario where EOL care and OD in effect overlap. Thus, the implementation of a cDCD program in France, as elsewhere, raised the issue of the potential impact of OD on WLST decision-making processes and EOL practices (particularly sedation). As other countries, the national protocol is nonetheless clear that the decision for WLST must be made in the bests interest of the patient and independent of any consideration of OD, and the donation pathway must not change EOL care. The challenge is not only to identify patients suitable as potential donors but also to provide support to grieving families and to make HCPs comfortable with OD in this particular context. In the specific context of cDCD, developing knowledge on the perceptions and experiences of relatives and ICU caregivers regarding OD is crucial but remains poorly investigated.
Investigators propose to conduct a prospective multicentric observational research to better understand relatives' and ICU caregivers' experience of cDCD.
A relative and/or at least two caregivers (1 physician and 1 or 2 paramedics) are included for any situation of death of a patient in ICU following a decision to withdraw LST and for which OD has been discussed with the relatives, whether or not the organ procurement finally occurred.
Two situations are distinguished:
- WLST without OD possibility: the WLST is initiated while OD is no longer considered for one of the following reasons: medical unsuitability, expressed intend not to be a donor or family refusal, legal issues, logistical problems, hemodynamic instability.
- WLST with OD possibility: the WLST is initiated while OD is still considered, whether or not OD finally occurs for one of the following reasons: circulatory death declared > 180 minutes, excessive warm ischemia time due to normothermic regional perfusion dysfunction or hypoperfusion.
At the time of the discussion about OD with the relatives :
- The screening for inclusion will be done.
- If 1 relative volunteers to participate in the study (non-opposition noted by the investigator), the situation is included in CARE-M3 "relative" section.
- If no relatives volunteer to participate in the study, the situation can be included in CARE M3 for the caregiver section after the patient's death.
After the patient death, wether or not OD occurs:
- 3 caregivers (1 physician and 2 paramedics) can be included. These are the caregivers who are present at the time the WLST is initiated.
- If at least two caregivers volunteer to participate in the study, the situation is included in CARE-M3 caregiver section.
Objectives concerning the relatives
- Primary objective: to study their risk of developing symptoms of post-traumatic stress disorder in the months following the patient's death.
- Secondary objectives: assessment of symptoms of anxiety, depression, complicated grief, assessment of understanding of the decision process to withdraw LST and the cDCD procedure.
Objectives concerning the ICU caregivers
- Primary objective: to study their risk developing anxiety relating to the event.
- Secondary objectives: evaluation of the impact of the cDCD procedure on the WLST decision-making process, end-of-life practices, support at the end-of-life (EOL) and quality of the EOL.
- Being tested
- Relative section, Caregiver section
- Keywords
- End-of-life, Withdrawal of life-sustaining treatments, Controlled donation after circulatory death
- Medical subject headings
- Suicide, Assisted, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relative sectionOther
Relatives are assessed by phone calling with an experienced psychologist at 3 and 6 months after patient's death. Relatives answer to self-questionnaire and 3 scales.
Furthermore, 20 of them are offered to participate in a semi-structured interview with an experienced psychologist, within 6 months to 1 year following the patient's death.
Caregiver sectionOther
Caregivers are self-evaluated within 72 hours after death by questionnaire survey, whose results will remain confidential to the center that included the situation.
Furthermore, 20 of them (10 medical staff and 10 paramedical staff and / or until saturation) are offered to participate in a semi-structured interview with an experienced psychologist.
| Study group | Role | What they receive |
|---|---|---|
| Relative volunteers | For each situation of death of a patient in ICU following a decision to withdraw LST and for which OD has been discussed with the relatives, a relative can be included after information and acceptance of the study. One relative per situation can be included : the most involved personn in the relationship with the resuscitation team. Receives: Other: Relative section | |
| Caregivers | For each situation of death of a patient in ICU following a decision to withdraw LST and for which OD has been considered, 2 to 3 caregivers who are present at the time the WLST is initiated can be included (1 physician and 1 or 2 paramedics). Receives: Other: Caregiver section |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hetero-evaluation of the relative using the IES-R scale
Hetero-evaluation of the relative with the IES-R score (Impact of. Event Scale - Revised score). Assessment is performed by telephone interview with an experienced psychologist. This scale measures the risk for the relative of exhibiting symptoms of post-traumatic stress disorder.
Measured: 3 months after patient's death
Self-report of the caregiver using the STAI inventory
The caregiver self-assess by responding confidentially to a questionnaire: the STAI inventory (State-Trait Anxiety Inventory). This questionnaire measures their risk of developing anxiety relating to the event.
Measured: within 72 hours following the patient's death
Secondary outcomes (9)
Hetero-evaluation of the relative using the HADS anxiety-depression scales
Hetero-evaluation of the relative with the Hospital Anxiety and Depression scales (HADS). Assessment is performed by telephone interview with an experienced psychologist. It measures symptoms of anxiety and depression.
Measured: 3 months after patient's death
Hetero-evaluation of the relative using the CAESAR end-of-life quality scale
Hetero-evaluation of the relative with the CAESAR end-of-life quality scale which assess the quality of end-of-life care in intensive care. Assessment is performed by telephone interview with an experienced psychologist.
Measured: 3 months after patient's death
Hetero-evaluation of the relative using the questionnaire survey
Assessment is performed by telephone interview with an experienced psychologist.
It consists in a questionnaire of around sixty questions assessing the following themes: progress of the end-of-life process, solicitation / discussion around organ donation, understanding of the process, end-of-life experience, support, relationship with caregivers, questions a posteriori.
Measured: 3 months after patient's death
Hetero-evaluation of the relative using the HADS anxiety-depression scales
Hetero-evaluation of the relative with the Hospital Anxiety and Depression scales (HADS). Assessment is performed by telephone interview with an experienced psychologist. It measures symptoms of anxiety and depression.
Measured: 6 months after patient's death
Hetero-evaluation of the relative using the IES-R scale
Hetero-evaluation of the relative with the IES-R score (Impact of. Event Scale - Revised score). Assessment is performed by telephone interview with an experienced psychologist. This scale measures the risk for the relative of exhibiting symptoms of post-traumatic stress disorder.
Measured: 6 months after patient's death
Hetero-evaluation of the relative using the PG-13 scale
Hetero-evaluation of the relative with the PG-13 scale (Prolonged Grief Disorder) which measures complicated mourning. Assessment is performed by telephone interview with an experienced psychologist.
Measured: 6 months after patient's death
Semi-structured interview with relative
20 relatives are selected among the included relatives to undergo a semi-structured interview conducted by an experienced psychologist in order to understand the experience of loved ones, the meaning given to the procedure, the impact of this procedure on the grieving process. These interviews will be carried out by phone call 6 months after the death within a maximum period of 12 months.
Measured: from 6 to 12 months after patient's death
Self-evaluation of the caregiver by questionnaire survey
A 29-question questionnaire is completed confidentially by the caregiver. The questionnaire addresses the following topics: perception and experience of the withdrawal of life-sustaining therapies (WLST), decision-making process; perception and experience of implementing the decision; perception and experience of soliciting families; experience of the dying process; experience of the role played and involvement of different caregivers during the different stages of the process; difficulties encountered and regrets; elements of satisfaction; aspects to improve.
Measured: within 72 hours following the patient's death
Semi-structured interview with caregiver
20 caregivers (10 medical staff and 10 paramedical staff and / or until saturation) are selected among the included caregivers in Ile de France to undergo a semi-structured interview conducted by an experienced psychologist.
Measured: from 6 to 12 months after patient's death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2021
- Study start27 Oct 2021
- Primary completion20 May 2024
- Study completion13 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Death, AssistedStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- 367 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Agence de La Biomédecine, Fondation de France
- Responsible party
- Sponsor
- Investigators
- Matthieu LE DORZE, Md, Study director, Department of anaesthesiology and critical care medicine. Lariboisiere Hospital.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05041023
- Sponsor's protocol ID
- APHP200936
- Acronym
- CARE-M3
- Status last verified
- Jan 2025
- First submitted
- 2 Sep 2021
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Le Dorze M, Renet A, Barthelemy R, Souppart V, Kentish-Barnes N; CARE-M3 Research Group. Relatives' experiences of end-of-life care and organ donation after controlled circulatory death: a national prospective multicenter study. Crit Care. 2025 Dec 21;30(1):42. doi: 10.1186/s13054-025-05807-8.
PubMed 41423695Le Dorze M, Barthelemy R, Lesieur O, Audibert G, Azais MA, Carpentier D, Cerf C, Cheisson G, Chouquer R, Degos V, Fresco M, Lambiotte F, Mercier E, Morel J, Muller L, Parmentier-Decrucq E, Prin S, Rouhani A, Roussin F, Venhard JC, Willig M, Vernay C, Chousterman B, Kentish-Barnes N; CARE-M3 Research Group. Tensions between end-of-life care and organ donation in controlled donation after circulatory death: ICU healthcare professionals experiences. BMC Med Ethics. 2024 Oct 9;25(1):110. doi: 10.1186/s12910-024-01093-1.
PubMed 39385217
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experience of Relatives and Caregivers of Death in ICU After the Withdrawal of Life-sustaining Therapies, Associated With an Organ Procurement Procedure (Controlled Donation After Circulatory Death).
- ClinicalTrials.gov ID
- NCT05041023
- Acronym / sponsor ID
- CARE-M3 / APHP200936
- Keywords
- End-of-life, Withdrawal of life-sustaining treatments, Controlled donation after circulatory death
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 367 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Agence de La Biomédecine, Fondation de France
- Study start
- 27 Oct 2021 (actual)
- Primary completion
- 20 May 2024 (actual)
- Study completion
- 13 Sep 2024 (actual)
- First posted
- 10 Sep 2021 (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.
Controlled donation after circulatory death (cDCD) refers to organ donation (OD) from patients whose death is defined using circulatory criteria and from whom circulatory death occurs after a planned withdrawal of life-sustaining therapies (WLST) in intensive care units (ICUs). During cDCD, the patient is still alive while OD process is being discussed and organized. Caregivers can be particularly uncomfortable in this scenario. In the specific context of cDCD, developing knowledge on the perceptions and experiences of relatives and ICU caregivers regarding OD is crucial but remains poorly investigated.
Investigators propose to conduct a prospective multicentric observational research to better understand relatives' and ICU caregivers' experience of cDCD. Better understanding their perceptions and experiences will enable to develop interventions to support and guide them throughout this practice.
Detailed description
While withdrawal of life-sustaining therapies (WLST) decision occur significantly more frequently in intensive care units (ICUs), controlled donation after circulatory death (cDCD) evolves end-of-life care and produces a new end-of-life (EOL) model: EOL care now includes the opportunity to donate organs and tissues after death. During cDCD, the patient is still alive while OD process is being discussed and organized. Caregivers can be particularly uncomfortable in this scenario where EOL care and OD in effect overlap. Thus, the implementation of a cDCD program in France, as elsewhere, raised the issue of the potential impact of OD on WLST decision-making processes and EOL practices (particularly sedation). As other countries, the national protocol is nonetheless clear that the decision for WLST must be made in the bests interest of the patient and independent of any consideration of OD, and the donation pathway must not change EOL care. The challenge is not only to identify patients suitable as potential donors but also to provide support to grieving families and to make HCPs comfortable with OD in this particular context. In the specific context of cDCD, developing knowledge on the perceptions and experiences of relatives and ICU caregivers regarding OD is crucial but remains poorly investigated.
Investigators propose to conduct a prospective multicentric observational research to better understand relatives' and ICU caregivers' experience of cDCD.
A relative and/or at least two caregivers (1 physician and 1 or 2 paramedics) are included for any situation of death of a patient in ICU following a decision to withdraw LST and for which OD has been discussed with the relatives, whether or not the organ procurement finally occurred.
Two situations are distinguished:
- WLST without OD possibility: the WLST is initiated while OD is no longer considered for one of the following reasons: medical unsuitability, expressed intend not to be a donor or family refusal, legal issues, logistical problems, hemodynamic instability.
- WLST with OD possibility: the WLST is initiated while OD is still considered, whether or not OD finally occurs for one of the following reasons: circulatory death declared > 180 minutes, excessive warm ischemia time due to normothermic regional perfusion dysfunction or hypoperfusion.
At the time of the discussion about OD with the relatives :
- The screening for inclusion will be done.
- If 1 relative volunteers to participate in the study (non-opposition noted by the investigator), the situation is included in CARE-M3 "relative" section.
- If no relatives volunteer to participate in the study, the situation can be included in CARE M3 for the caregiver section after the patient's death.
After the patient death, wether or not OD occurs:
- 3 caregivers (1 physician and 2 paramedics) can be included. These are the caregivers who are present at the time the WLST is initiated.
- If at least two caregivers volunteer to participate in the study, the situation is included in CARE-M3 caregiver section.
Objectives concerning the relatives
- Primary objective: to study their risk of developing symptoms of post-traumatic stress disorder in the months following the patient's death.
- Secondary objectives: assessment of symptoms of anxiety, depression, complicated grief, assessment of understanding of the decision process to withdraw LST and the cDCD procedure.
Objectives concerning the ICU caregivers
- Primary objective: to study their risk developing anxiety relating to the event.
- Secondary objectives: evaluation of the impact of the cDCD procedure on the WLST decision-making process, end-of-life practices, support at the end-of-life (EOL) and quality of the EOL.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Relative volunteers | – | Other: Relative sectionFor each situation of death of a patient in ICU following a decision to withdraw LST and for which OD has been discussed with the relatives, a relative can be included after information and acceptance of the study. One relative per situation can be included : the most involved personn in the relationship with the resuscitation team. |
| Caregivers | – | Other: Caregiver sectionFor each situation of death of a patient in ICU following a decision to withdraw LST and for which OD has been considered, 2 to 3 caregivers who are present at the time the WLST is initiated can be included (1 physician and 1 or 2 paramedics). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The relatives of patients who have died in ICU are the first attendant of the patient at the end-of-life EOL. During this procedure, relatives are particularly solicited because they are strongly involved in the decision-making process. The most involved relative in the relationship with the resuscitation team will be asked to participate in the study. Caregivers included in the study are caregivers from ICU who are present at the time the withdrawal of life-sustaining therapies WLST is initiated: at least 1 physician and 1 or 2 paramedics.
Key inclusion criteria (5 listed)
- Any situation of anticipated death of a patient in Intensive Care Unit ICU due to circulatory arrest:
- For which a decision to withdraw Life-Sustaining Therapies LST was taken under the Claeys-Leonetti law, notified to relatives and accepted by relatives
- With a first evaluation by the hospital coordination of organ and tissue removal identifying the patient at the end of life as a potential donor: patient identified under the age of 70, with no absolute contraindication to organ removal in the context of an M3 procedure
- For which Organ Donation OD has been discussed with the relatives, whether the OD finally occurred.
- Relative and/or caregiver who has given non-objection to the use of the data.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relative sectionRelatives are assessed by phone calling with an experienced psychologist at 3 and 6 months after patient's death. Relatives answer to self-questionnaire and 3 scales. Furthermore, 20 of them are offered to participate in a semi-structured interview with an experienced psychologist, within 6 months to 1 year following the patient's death. | Other | Relative volunteers |
| Caregiver sectionCaregivers are self-evaluated within 72 hours after death by questionnaire survey, whose results will remain confidential to the center that included the situation. Furthermore, 20 of them (10 medical staff and 10 paramedical staff and / or until saturation) are offered to participate in a semi-structured interview with an experienced psychologist. | Other | Caregivers |
Primary outcome
Hetero-evaluation of the relative using the IES-R scale
Time frame: 3 months after patient's death
Hetero-evaluation of the relative with the IES-R score (Impact of. Event Scale - Revised score). Assessment is performed by telephone interview with an experienced psychologist. This scale measures the risk for the relative of exhibiting symptoms of post-traumatic stress disorder.
Self-report of the caregiver using the STAI inventory
Time frame: within 72 hours following the patient's death
The caregiver self-assess by responding confidentially to a questionnaire: the STAI inventory (State-Trait Anxiety Inventory). This questionnaire measures their risk of developing anxiety relating to the event.
9 secondary outcomes
Hetero-evaluation of the relative using the HADS anxiety-depression scales
Time frame: 3 months after patient's death
Hetero-evaluation of the relative using the CAESAR end-of-life quality scale
Time frame: 3 months after patient's death
Hetero-evaluation of the relative using the questionnaire survey
Time frame: 3 months after patient's death
Hetero-evaluation of the relative using the HADS anxiety-depression scales
Time frame: 6 months after patient's death
Hetero-evaluation of the relative using the IES-R scale
Time frame: 6 months after patient's death
Hetero-evaluation of the relative using the PG-13 scale
Time frame: 6 months after patient's death
Semi-structured interview with relative
Time frame: from 6 to 12 months after patient's death
Self-evaluation of the caregiver by questionnaire survey
Time frame: within 72 hours following the patient's death
Semi-structured interview with caregiver
Time frame: from 6 to 12 months after patient's death
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 15 Jan 2025.
- Derived from this study: PubMed 41423695Le Dorze M, Renet A, Barthelemy R, Souppart V, Kentish-Barnes N; CARE-M3 Research Group. Relatives' experiences of end-of-life care and organ donation after controlled circulatory death: a national prospective multicenter study. Crit Care. 2025 Dec 21;30(1):42. doi: 10.1186/s13054-025-05807-8.
- Derived from this study: PubMed 39385217Le Dorze M, Barthelemy R, Lesieur O, Audibert G, Azais MA, Carpentier D, Cerf C, Cheisson G, Chouquer R, Degos V, Fresco M, Lambiotte F, Mercier E, Morel J, Muller L, Parmentier-Decrucq E, Prin S, Rouhani A, Roussin F, Venhard JC, Willig M, Vernay C, Chousterman B, Kentish-Barnes N; CARE-M3 Research Group. Tensions between end-of-life care and organ donation in controlled donation after circulatory death: ICU healthcare professionals experiences. BMC Med Ethics. 2024 Oct 9;25(1):110. doi: 10.1186/s12910-024-01093-1.
- 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.
Matthieu LE DORZE, Md study director
Department of anaesthesiology and critical care medicine. Lariboisiere Hospital.
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 Death, Assisted and Tissue and Organ Procurement, run by Assistance Publique - Hôpitaux de Paris 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 5 inclusion and 1 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 15 Jan 2025. 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?
Hetero-evaluation of the relative using the IES-R scale (time frame: 3 months after patient's death). The study lists 2 primary outcomes in all. 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 NCT05041023, which also lists 2 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 15 Jan 2025.