Condition category
Circulatory System
Date applied
21/11/2013
Date assigned
21/11/2013
Last edited
16/03/2016
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

Prof Gavin Murphy

ORCID ID

Contact details

Groby Road
Leicester
LE3 9QP
United Kingdom
-
gjm19@le.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

13922

Study information

Scientific title

A randomised controlled trial of red cell washing for the attenuation of transfusion associated organ injury in cardiac surgery

Acronym

REDWASH

Study hypothesis

Cardiac surgery is one of the main users of allogeneic blood nationally. Blood transfusion may have unwanted side-effects that increase the risk of inflammation and complications after cardiac surgery which typically affect the kidneys heart and lungs. We believe that this may be due to the release of chemicals and microscopic particles by the red blood cells during storage that collect in the blood bag (the so-called storage lesion). Currently these by-products are transfused to the patient along with the donor blood.

This research study will investigate whether removing the storage by-products by washing blood cells immediately prior to transfusion will improve these common complications in cardiac surgery.

Ethics approval

12/EM/0475

Study design

Randomised; Interventional; Design type: Not specified, Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Cardiovascular; Subtopic: Cardiovascular (all Subtopics); Disease: Cardiac Surgery

Intervention

Patients will first be screened and, if they are eligible, they will be randomly allocated to receive either unwashed (standard practice in UK) or washed RBC units, if they require a blood transfusion during or immediately after surgery.

There will be a series of assessments during their hospital stay and 1 follow up visit and it is expected that each participant will be in the study for approximately 6 weeks.

The study is designed to compare both presence and intensity of inflammation and complications in both treatment groups by measuring certain biomarkers in the blood (cytokines) and urine. There will be additional tests aimed at identifying the underlying mechanisms of organ dysfunction. We will also look how safe the study intervention and what side effects, if any it causes.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Severity of the systemic inflammatory response as determined by serial cytokine measures; Timepoint(s): Over the first 96 hours

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/03/2013

Overall trial end date

31/05/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adult cardiac surgery patients (16 years to 80 years) undergoing cardiac surgery with blood cardioplegia
2. Identified as representing a high risk group for massive blood transfusion using a modified transfusion risk score
Target Gender: Male & Female; Upper Age Limit 80 years ; Lower Age Limit 16 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 170; UK Sample Size: 170; Description: 85 participants per treatment arm.

Participant exclusion criteria

1. Emergency or salvage procedure
2. Ejection fraction <20%, i.e. very poor left ventricular function
3. Patients with end stage renal failure defined as an estimated Glomerular Filtration rate (eGFR) <15ml/min/1.72m2 calculated from the Modification of Diet in Renal Disease equation [32], or patients who are on long-term haemodialysis or have undergone renal transplantation
4. Patients who are prevented from having blood and blood products according to a system of beliefs (e.g. Jehovah’s Witnesses)
5. Patients with a pre-existing inflammatory state (e.g. sepsis, active inflammatory disease including active rheumatoid arthritis, colitis, Lupus, or Crohn’s disease. NB: consider latter conditions as active conditions when a patient is taking a high dose of oral steroids, for example > 10 mg/day of prednisolone).
6. Patients with congenital or acquired RBC, platelet or clotting factor disorders, (excluding those receiving anti-platelet therapy, warfarin or other systemic oral anticoagulants)
7. Patient in a critical preoperative state (Kidney Disease: Improving Global Outcomes (KDIGO) Stage 3 AKI or requiring ionotropes, ventilation or intra-aortic balloon pump) preoperatively
8. Pregnancy
9. Patients who are participating in another interventional clinical study

Recruitment start date

01/03/2013

Recruitment end date

31/05/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Groby Road
Leicester
LE3 9QP
United Kingdom

Sponsor information

Organisation

University of Leicester (UK)

Sponsor details

Department of Genetics
University Road
Leicester
LE1 7RH
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

NIHR Central Commissioning Facility; Grant Codes: RP-PG-0407-10384

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

2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26977309

Publication citations

Additional files

Editorial Notes

08/03/2016: Publication reference added.