Condition category
Not Applicable
Date applied
22/03/2007
Date assigned
16/07/2007
Last edited
12/10/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Duncan Young

ORCID ID

Contact details

c/o Miss Sarah Edwards
Kadoorie Centre for Critical Care Research and Education
Level 3 John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom

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

Sponsor information

Organisation

Oxford Radcliffe Hospitals NHS Trust (UK)

Sponsor details

Research and Develpment Office
Manor House
John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom

Sponsor type

Government

Website

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

  1. Effect of "collaborative requesting" on consent rate for organ donation: randomised controlled trial (ACRE trial)., BMJ, 2009, 339, b3911.

Additional files

Editorial Notes