A multi-centre randomised controlled trial of the effects of a reduction in the threshold for blood transfusion following heart surgery

Not Applicable

Completed

• Conditions: Patients undergoing cardiac surgery; Surgery

• Registration Number: ISRCTN70923932
• Lead Sponsor: niversity Hospitals Bristol NHS Foundation Trust (UK)

Brief Summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24675014 2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25760354 2015 statistical analysis plan in: http://www.ncbi.nlm.nih.gov/pubmed/25881049 2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27481621

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-09-09
• Study Completion: 2011-11-30
• Last Update Posted: 19 March 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

Current inclusion criteria as of 24/08/2010:
1. Adults of either sex, aged =16
2. Post-operative nadir Hb / Hct level below 9.0 g / dL / 27

Previous inclusion criteria from 01/09/2009 to 24/08/2010:
1. Adults of either sex, aged =16 and <80 years
2. Post-operative nadir Hb / Hct level below 9.0 g / dL / 27

Initial information at time of registration:
1. Adults of either sex, aged =16 and <80 years
2. Post-operative nadir Hb level below 9.0 g/d

Exclusion Criteria

Current information as of 01/09/2009:
1. Patients who are prevented from having blood and blood products according to a system of beliefs (e.g., Jehovah's Witnesses)
2. Patients with congenital or acquired platelet, red cell or clotting disorders
3. Patients with ongoing or recurrent sepsis
4. Patients who were unable to give full informed consent for the study (e.g., learning or language difficulties)
5. Patients with critical limb ischaemia
6. Patients undergoing emergency surgery
7. Patients already participating in another interventional research study

Initial information at time of registration:
1. Patients who are prevented from having blood and blood products according to a system of beliefs (e.g., Jehovah's Witnesses)
2. Patients with congenital or acquired platelet, red cell or clotting disorders
3. Patients with ongoing or recurrent systemic sepsis
4. Patients who were unable to give full informed consent for the study (e.g., learning or language difficulties)
5. Patients with a critical carotid artery stenosis (>75%) or critical limb ischaemia
6. Patients with flow limiting (>70% luminal stenosis) coronary artery disease not undergoing complete revascularisation

Study & Design

• Study Type: Interventional
• Study Design: Not specified