The most common reason for not obtaining donation after brain death (DBD) or donation after controlled circulatory death (DCD) in France is refusal of consent by the relatives. Many observational studies suggest that consent rates may increase when the request is made by specially trained and highly experienced professionals. One technique that may maximize the consent rate is collaborative requesting made jointly by the physician in charge of the patient and an organ procurement coordinator (OPC).
Although the general principles are the same for DCD as for DBD, several differences and specificities exist. First, withdrawal of life-sustaining treatments (WLST) decisions should be entirely independent from organ-donation considerations, in order to eliminate potential conflicts of interest. However, separating conversations about WLST and donation may not always be possible. Potential DCD situations often occur after an extended ICU stay with the development of close ties between families and staff. The ICU physician may therefore feel that suggesting donation during the WLST conversation serves the family-ICU staff relationship.
An unblinded multicenter randomized controlled trial tested the null hypothesis of no difference in organ-donation consent rates between collaborative requesting (clinical team and OPC together) vs. the clinical team only (routine requesting). The potential donors met criteria for brain-stem death or had impending brain-stem death; none were candidates for DCD. Collaborative requesting did not increase the consent rate.
The PRODON study will test whether collaborative requesting by the ICU team and OPC decreases the rate of DCD refusal by families compared to routine requesting by the ICU team only.
Patient 18 years or more Patients in the ICU for whom a decision to withdraw life-sustaining treatments (WLST) has been made and for whom the cessation of circulatory and respiratory functions is anticipated to occur within a time frame that will enable organ recovery
Patient's relative 18 years or more Has consented to participate in the trial Has had at least one conversation with the clinical team before study inclusion Has good knowledge of spoken French
None
Parallel
Collaborative request
Other interventionThe relative is approached by the clinical team and an organ procurement coordinator together.
Rate of DCD refusal by the family
Our primary outcome measure (refusal of organ donation) will be determined very shortly after the organ-donation request.
The Hospital Anxiety and Depression Scale (HADS) completed by the participating relative
The Hospital Anxiety and Depression Scale (HADS), which measures symptoms of anxiety and depression, will be completed by the participating relative. 2 scores are calculated: Seven questions relate to anxiety (total A) and seven others to the depressive dimension (total D), allowing thus obtaining two scores (maximum score for each score = 21). Minimum score =0. A high score corresponds to the "worst outcome". Lower (better) HADS scores are expected in the collaborative group at both time points
The Revised Impact of Event Scale (IES-R) completed by the participating
The Revised Impact of Event Scale (IES-R), which assesses the risk of developing post-traumatic stress syndrome, will be completed by the participating relative. Lower (better) IES-R scores are expected in the collaborative group at both time points.
The Inventory of Complicated Grief (ICG) completed by the participating relative
The Inventory of Complicated Grief (ICG), which measures symptoms of protracted/complicated grief, will be completed by the participating relative. Lower (better) ICG scores are expected in the collaborative group
A qualitative psychosociological evaluation of the experience of the family
A qualitative psychosociological evaluation of the experience of the family with collaborative vs. ICU-team-only requesting will be performed in 40 relatives during a telephone interview with a psychologist or sociologist
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Nantes University Hospital
Lead sponsor
University of Burgundy
Collaborator
Famirea Study Group
Collaborator
