Point-of-Care RBC Washing to Prevent Transfusion-Related Pulmonary Complications

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.

Study Overview

• Status: Completed
• Conditions: Blood Transfusion Complications
• Intervention / Treatment: Biological: Standard of care red blood cell transfusion.; Biological: Point-of-care washed red blood cell transfusion.

• Study Type: Interventional
• Enrollment (Actual): 171
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of care red blood cell transfusion; Red blood cells that are administered in the normal fashion.	Biological: Standard of care red blood cell transfusion.
Experimental: Point-of-Care washed red blood cell transfusion; Red blood cells that are washed at the point-of-care.	Biological: Point-of-care washed red blood cell transfusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biomarkers Associated With Transfusion-Related Acute Lung Injury and Transfusion Associated Circulatory Overload.	This panel of biomarkers measures inflammation, altered coagulation, and endothelial activation all of which play key roles in the pathogenesis of lung injury.	18 hours after the initiation of the first red blood cell transfusion.
Number of "Off-protocol" Transfusions	The number of standard issued red blood cell units that were transfused to study participants in the washed red blood cell arm of the trial. Additionally, emergency red blood cell transfusions in the standard issued arm of the trial that were administered outside of the study protocol were also included to the definition of "off protocol" transfusion.	Day of surgery. Approximately 1 day.
Change in Recipient Hemoglobin	Change in Hemoglobin from pre-transfusion to post-transfusion	Pre to 6 hours post transfusion
Change in Recipient Cell Free Hemoglobin(CFH)	Change in CFH from pre-transfusion to worst (highest/maximum) post-transfusion	Pre transfusion until study day 5 or hospital discharge, approximately 5 days
Change in Haptoglobin	Change in Haptoglobin from pre-transfusion to worst (minimum) post-transfusion	Pre transfusion to study day 5 or hospital discharge, approximately 5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Mechanical Ventilation	Number of hours subject received mechanical ventilation.	Up to hospital day 28, or discharge, whichever comes first
Duration of Oxygen Supplementation	Number of hours subjects received supplemental oxygen.	Up to day 28, or hospital discharge, whichever comes first
Sequential Organ Failure Assessment (SOFA) Score	Worst SOFA score between Day 1 and Day 5. SOFA scores range from 0-24 with 0 meaning no organ dysfunction and 24 means severe dysfunction of all organ systems evaluated. Each of 6 organ systems are scored on a 0-4 scale with the cumulative score being the total SOFA score.	Through postoperative day 5.
Hospital Length of Stay	Number of days subject remained in the hospital following their surgical procedure. If the number of days the subject remained in the hospital exceeded 28, a value of 28 is assigned.	Up to day 28
Post Transfusion Respiratory Complications.	Development of transfusion-related lung injury (TRALI) or transfusion-associated circulatory overload (TACO).	Up to day 28

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: Duke University; Blood Systems Research Institute
• Investigators: Principal Investigator: Daryl Kor, MD, Mayo Clinic

Publications and helpful links

General Publications

• 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.

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): May 30, 2019
• Study Completion (Actual): May 30, 2019

Study Registration Dates

• First Submitted: March 19, 2014
• First Submitted That Met QC Criteria: March 20, 2014
• First Posted (Estimate): March 21, 2014

Study Record Updates

• Last Update Posted (Actual): April 6, 2021
• Last Update Submitted That Met QC Criteria: March 11, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: surgery; cardiac; Transfusion; RBC; transfusion related acute lung injury (TRALI); transfusion associated circulatory overload (TACO)
• Additional Relevant MeSH Terms: Immune System Diseases; Hematologic Diseases; Transfusion Reaction
• Other Study ID Numbers: 13-005965

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No