Factors Influencing Corneal Donation in Palliative Care Unit
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGroupe Hospitalier Diaconesses Croix Saint-Simon
About this trial
Today, there is a shortage of tissues such as corneas for a variety of reasons. However, it is possible to harvest tissues from people who are usually excluded from donation, particularly cancer diagnosed, by recruiting them into palliative care units.
Corneal transplantation is a surgical procedure designed to improve the vision of many persons. A number of diseases now require corneal transplants, such as keratoconus.
As with other organs, the shortage of donors remains a major obstacle to the use of this technique, a shortage which became much more acute during the health crisis linked to the pandemic caused by the SARS-CoV-2 virus. In 2022, 10615 participants were waiting for a transplant, but only 46.3% of them received one.
Cornea removal differs from the removal of other organs. Firstly, there are fewer contra-indications. It can be performed on persons with chronic conditions that would usually exclude them from receiving other organs, such as cancer. As the cornea is not vascularised, the risk of damage is considered to be zero, except in cases of cancers of cerebral neurological origin or melanoma.
Secondly, the donor's remains can be preserved for up to 24 hours after death. This makes it possible to recruit care services that are not usually involved in organ transplants, as these services provide new potential donor recruitment resources. This includes palliative care units.
There is currently no French literature on corneal donation specifically in palliative care units. There is a lack of data on the factors that encourage or hinder donation.
Based on our experience of corneal donation in our palliative care unit since 2020, the investigators are conducting a clinical study to evaluate the factors that facilitate or impede corneal donation in our hospital palliative care unit.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Relative or confidant over 18 years of age.
Relative or confidant has received written and oral information on the conditions for participation in this study.
Relative or confidant has signed an informed consent form.
Disqualifiers
Confidant person who does not speak or read French.
Confidant person with a sensory deficit that makes it impossible to carry out an interview.
Confidant person under protective supervision (guardianship, curatorship, or safeguard of justice.
Trial population
The source population concerned by this study corresponds to the relatives of the deceased person who has been treated in the palliative care unit, limited to 3 relatives.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
150 Participants
are grouped into 2 trial groupsGroup A: Relatives agree for the corneal donation
Group B: Relatives disagree for the corneal donation
Trial outcomes
Primary outcomes
1
Biographical, Care Experience, and Organ donation attitude characteristics as assessed by structured questionnaires.
Data collected include biographical and social characteristics of the relative, perceived quality of care in the palliative care unit, experience of being approached regarding corneal donation, and attitudes toward organ and tissue donation.
Time frame
Enrolment visit and/or month 3Secondary outcomes
1
Relatives' perceptions of Cornea Donation Requests following death in the Palliative Care Unit assessed by semi-structured interview.
Time frame
Enrolment visit and/or month 32
Perceptions of Corneal donation following death in a Palliative Care Unit assessed by structured questionnaire.
Perceptions and experiences related to corneal donation when death occurs in a palliative care unit, including factors facilitating or hindering consent to donation, assessed through a structured questionnaire administered to relatives of deceased patients.
Time frame
Enrolment visit and/or month 33
Questionnaire-Based characteristics of relatives opposed and not opposed to Corneal Donation.
Comparison of demographic characteristics, care experience, and attitudes toward organ and tissue donation between relatives opposed and not opposed to corneal donation, assessed by a structured questionnaire.
Time frame
Month 39Sponsors and contacts
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Source ClinicalTrials.gov