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

Primary Purpose

Blood Transfusion Complications

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Point-of-care washed red blood cell transfusion.
Standard of care red blood cell transfusion.
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Blood Transfusion Complications focused on measuring Transfusion, RBC, cardiac, surgery, transfusion related acute lung injury (TRALI), transfusion associated circulatory overload (TACO)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic in Rochester
  • Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard of care red blood cell transfusion

Point-of-Care washed red blood cell transfusion

Arm Description

Red blood cells that are administered in the normal fashion.

Red blood cells that are washed at the point-of-care.

Outcomes

Primary Outcome Measures

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.
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.
Change in Recipient Hemoglobin
Change in Hemoglobin from pre-transfusion to post-transfusion
Change in Recipient Cell Free Hemoglobin(CFH)
Change in CFH from pre-transfusion to worst (highest/maximum) post-transfusion
Change in Haptoglobin
Change in Haptoglobin from pre-transfusion to worst (minimum) post-transfusion

Secondary Outcome Measures

Duration of Mechanical Ventilation
Number of hours subject received mechanical ventilation.
Duration of Oxygen Supplementation
Number of hours subjects received supplemental oxygen.
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.
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.
Post Transfusion Respiratory Complications.
Development of transfusion-related lung injury (TRALI) or transfusion-associated circulatory overload (TACO).

Full Information

First Posted
March 19, 2014
Last Updated
March 11, 2021
Sponsor
Mayo Clinic
Collaborators
Duke University, Vitalant Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02094118
Brief Title
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

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
May 30, 2019 (Actual)
Study Completion Date
May 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
Duke University, Vitalant Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Transfusion Complications
Keywords
Transfusion, RBC, cardiac, surgery, transfusion related acute lung injury (TRALI), transfusion associated circulatory overload (TACO)

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
171 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of care red blood cell transfusion
Arm Type
Active Comparator
Arm Description
Red blood cells that are administered in the normal fashion.
Arm Title
Point-of-Care washed red blood cell transfusion
Arm Type
Experimental
Arm Description
Red blood cells that are washed at the point-of-care.
Intervention Type
Biological
Intervention Name(s)
Point-of-care washed red blood cell transfusion.
Intervention Type
Biological
Intervention Name(s)
Standard of care red blood cell transfusion.
Primary Outcome Measure Information:
Title
Biomarkers Associated With Transfusion-Related Acute Lung Injury and Transfusion Associated Circulatory Overload.
Description
This panel of biomarkers measures inflammation, altered coagulation, and endothelial activation all of which play key roles in the pathogenesis of lung injury.
Time Frame
18 hours after the initiation of the first red blood cell transfusion.
Title
Number of "Off-protocol" Transfusions
Description
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.
Time Frame
Day of surgery. Approximately 1 day.
Title
Change in Recipient Hemoglobin
Description
Change in Hemoglobin from pre-transfusion to post-transfusion
Time Frame
Pre to 6 hours post transfusion
Title
Change in Recipient Cell Free Hemoglobin(CFH)
Description
Change in CFH from pre-transfusion to worst (highest/maximum) post-transfusion
Time Frame
Pre transfusion until study day 5 or hospital discharge, approximately 5 days
Title
Change in Haptoglobin
Description
Change in Haptoglobin from pre-transfusion to worst (minimum) post-transfusion
Time Frame
Pre transfusion to study day 5 or hospital discharge, approximately 5 days
Secondary Outcome Measure Information:
Title
Duration of Mechanical Ventilation
Description
Number of hours subject received mechanical ventilation.
Time Frame
Up to hospital day 28, or discharge, whichever comes first
Title
Duration of Oxygen Supplementation
Description
Number of hours subjects received supplemental oxygen.
Time Frame
Up to day 28, or hospital discharge, whichever comes first
Title
Sequential Organ Failure Assessment (SOFA) Score
Description
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.
Time Frame
Through postoperative day 5.
Title
Hospital Length of Stay
Description
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.
Time Frame
Up to day 28
Title
Post Transfusion Respiratory Complications.
Description
Development of transfusion-related lung injury (TRALI) or transfusion-associated circulatory overload (TACO).
Time Frame
Up to day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daryl Kor, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28821525
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.
Results Reference
derived
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

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

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