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

Not Applicable

Completed

• Conditions: Topic: Cardiovascular; Subtopic: Cardiovascular (all Subtopics); Disease: Cardiac Surgery; Circulatory System

• Registration Number: ISRCTN27076315
• Lead Sponsor: niversity of Leicester (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11-21
• Last Update Posted: 5 June 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 170

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified