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 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 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 trial start date
01/03/2013
Overall trial end date
31/05/2014
Reason abandoned (if study stopped)
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. 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
Recruitment start date
01/03/2013
Recruitment end date
31/05/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Leicester
Leicester
LE1 7RH
United Kingdom
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
Basic results (scientific)
Publication list
2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26977309
2017 results in: http://www.ncbi.nlm.nih.gov/pubmed/28475670