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

ISRCTN	ISRCTN27076315
DOI	https://doi.org/10.1186/ISRCTN27076315
Secondary identifying numbers	13922

Submission date: 21/11/2013
Registration date: 21/11/2013
Last edited: 08/05/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Gavin Murphy
Scientific

Groby Road
Leicester
LE3 9QP
United Kingdom

Email	gjm19@le.ac.uk

Study information

Study design	Randomised; Interventional; Design type: Not specified, Treatment
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	A randomised controlled trial of red cell washing for the attenuation of transfusion associated organ injury in cardiac surgery
Study acronym	REDWASH
Study objectives	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(s)	12/EM/0475
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/03/2013
Completion date	31/05/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	Planned Sample Size: 170; UK Sample Size: 170; Description: 85 participants per treatment arm.
Key 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
Key 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. Jehovahs Witnesses) 5. Patients with a pre-existing inflammatory state (e.g. sepsis, active inflammatory disease including active rheumatoid arthritis, colitis, Lupus, or Crohns 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
Date of first enrolment	01/03/2013
Date of final enrolment	31/05/2014

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University of Leicester

Leicester
LE1 7RH
United Kingdom

Sponsor information

University of Leicester (UK)
University/education

Department of Genetics
University Road
Leicester
LE1 7RH
England
United Kingdom

"ROR"	https://ror.org/04h699437

Funders

Funder type

Government

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	07/03/2016		Yes	No
Results article	results	01/05/2017		Yes	No
HRA research summary			28/06/2023	No	No

Editorial Notes

08/05/2017: Publication reference added.
08/03/2016: Publication reference added.