Point-of-Care RBC Washing to Prevent Transfusion-Related Pulmonary Complications
1 other identifier
interventional
171
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2016
Typical duration for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 19, 2014
CompletedFirst Posted
Study publicly available on registry
March 21, 2014
CompletedStudy Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2019
CompletedResults Posted
Study results publicly available
April 6, 2021
CompletedApril 6, 2021
February 1, 2021
3.4 years
March 19, 2014
February 8, 2021
March 11, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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 Outcomes (5)
Duration of Mechanical Ventilation
Up to hospital day 28, or discharge, whichever comes first
Duration of Oxygen Supplementation
Up to day 28, or hospital discharge, whichever comes first
Sequential Organ Failure Assessment (SOFA) Score
Through postoperative day 5.
Hospital Length of Stay
Up to day 28
Post Transfusion Respiratory Complications.
Up to day 28
Study Arms (2)
Standard of care red blood cell transfusion
ACTIVE COMPARATORRed blood cells that are administered in the normal fashion.
Point-of-Care washed red blood cell transfusion
EXPERIMENTALRed blood cells that are washed at the point-of-care.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
- Duke Universitycollaborator
- Vitalant Research Institutecollaborator
Study Sites (2)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Related Publications (1)
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.
PMID: 28821525DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Daryl Kor
- Organization
- Mayo Clinic
Study Officials
- PRINCIPAL INVESTIGATOR
Daryl Kor, MD
Mayo Clinic
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Anesthsiology
Study Record Dates
First Submitted
March 19, 2014
First Posted
March 21, 2014
Study Start
January 1, 2016
Primary Completion
May 30, 2019
Study Completion
May 30, 2019
Last Updated
April 6, 2021
Results First Posted
April 6, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share