Clinical trial NCT02094118: Point-of-Care RBC Washing to Prevent Transfusion-Related Pulmonary Complications
Official title: Point-of-Care RBC Washing to Prevent Transfusion-Related Pulmonary Complications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Blood Transfusion Complications
Keywords: Transfusion
RBC
cardiac
surgery
transfusion related acute lung injury (TRALI)
transfusion associated circulatory overload (TACO)
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Duke University
name: Vitalant Research Institute
First posted: 2014-03-21
Enrollment: 171
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is designed to determine if point-of-care washing of allogeneic Leukocyte-Reduced Red Blood Cells reduces pulmonary complications when compared to standard-of-care Leukocyte-Reduced Red Blood Cells in a cardiac surgical population.


Eligibility criteria: Inclusion Criteria:

* Age equal to or greater than 18 years of age.
* Scheduled to have cardiac bypass surgery at Mayo Clinic in Rochester, Minnesota or Duke University Medical Center in Durham, North Carolina
* At risk for needing at least 4 units of blood during/after surgery

Exclusion Criteria:

* Emergency surgery
* Immunoglobulin A (IgA) deficiency
* History of severe recurrent transfusion reactions
* Refusal to receive allogeneic blood products
* Refusal to provide informed consent
* Prevalent lung injury prior to randomization
* Prevalent congestive heart failure prior to randomization
* Expected hospital stay \< 48 hours
* Not anticipated to survive \> 48 hours
* Previously enrolled in this trial
* No plan for placement of a pulmonary artery catheter
* Use of home oxygen therapy
* Complex RBC antibody profiles
* Need for the use of irradiated RBCs

Primary outcomes:
measure: Biomarkers Associated With Transfusion-Related Acute Lung Injury and Transfusion Associated Circulatory Overload.
timeFrame: 18 hours after the initiation of the first red blood cell transfusion.
measure: Number of "Off-protocol" Transfusions
timeFrame: Day of surgery. Approximately 1 day.
measure: Change in Recipient Hemoglobin
timeFrame: Pre to 6 hours post transfusion
measure: Change in Recipient Cell Free Hemoglobin(CFH)
timeFrame: Pre transfusion until study day 5 or hospital discharge, approximately 5 days
measure: Change in Haptoglobin
timeFrame: Pre transfusion to study day 5 or hospital discharge, approximately 5 days
Secondary outcomes:
measure: Duration of Mechanical Ventilation
timeFrame: Up to hospital day 28, or discharge, whichever comes first
measure: Duration of Oxygen Supplementation
timeFrame: Up to day 28, or hospital discharge, whichever comes first
measure: Sequential Organ Failure Assessment (SOFA) Score
timeFrame: Through postoperative day 5.
measure: Hospital Length of Stay
timeFrame: Up to day 28
measure: Post Transfusion Respiratory Complications.
timeFrame: Up to day 28
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Mayo Clinic
name: Daryl Kor, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Warner MA, Welsby IJ, Norris PJ, Silliman CC, Armour S, Wittwer ED, Santrach PJ, Meade LA, Liedl LM, Nieuwenkamp CM, Douthit B, van Buskirk CM, Schulte PJ, Carter RE, Kor DJ. Point-of-care washing of allogeneic red blood cells for the prevention of transfusion-related respiratory complications (WAR-PRC): a protocol for a multicenter randomised clinical trial in patients undergoing cardiac surgery. BMJ Open. 2017 Aug 18;7(8):e016398. doi: 10.1136/bmjopen-2017-016398.