Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Protocol v5.2
Study information
Scientific title
Acronym
ACRE
Study hypothesis
Relatives of patients in whom death has been determined using brain stem death criteria are more likely to consent to organ donation when interviewed by the clinical team if a donor transplant co-ordinator is present, compared with relatives interviewed by the clinical team alone.
Ethics approval
Approved by Oxfordshire Research Ethics Committee A (Ref: 06/Q1604/119)
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Other
Patient information sheet
Condition
Relatives of brain stem dead patients; Organ donation - collaborative requesting
Intervention
The intervention is collaborative requesting which is the addition of a donor transplant co-ordinator to the team requesting organ donation. The routine arm is the relatives interviewed by the clinical team alone.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Proportion of relatives refusing consent for organ donation.
Secondary outcome measures
1. Number of patients in whom the family consent to beating heart organ donation
2. Solid organs retrieved by type
3. Solid organs transplanted by type
4. Tissues retrieved by type
5. Consent rates by predefined subgroup (relative relationship to donor; ethnic group and sex of donor and next of kin; clinician seniority and sex; sex of donor transplant co-ordinator)
Overall trial start date
01/04/2007
Overall trial end date
01/08/2009
Reason abandoned
Eligibility
Participant inclusion criteria
Relatives of patients in whom death has been determined using brain stem death criteria
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
946
Participant exclusion criteria
1. Relatives who do not understand written or verbal infromation for whom an interpreter is not available
2. Relatives who decline discussion on organ donation
Recruitment start date
01/04/2007
Recruitment end date
01/08/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
c/o Miss Sarah Edwards
Oxford
OX3 9DU
United Kingdom
Funders
Funder type
Government
Funder name
UK Transplant
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19815583?
Publication citations
-
Effect of "collaborative requesting" on consent rate for organ donation: randomised controlled trial (ACRE trial)., BMJ, 2009, 339, b3911.