Phase 2 N=171 Randomized Single-blind Prevention

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

Blood Transfusion Complications

Bottom Line

View on ClinicalTrials.gov: NCT02094118 ↗

Enrolled (actual)

171

Serious AEs

4.1%

Results posted

Apr 2021

Primary outcome: Primary: Biomarkers Associated With Transfusion-Related Acute Lung Injury and Transfusion Associated Circulatory Overload. — 101; 105; 12; 15 units on a scale (pg/ml)

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Point-of-care washed red blood cell transfusion. (Biological); Standard of care red blood cell transfusion. (Biological)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Mayo Clinic
Primary completion: May 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Biomarkers Associated With Transfusion-Related Acute Lung Injury and Transfusion Associated Circulatory Overload.	101; 105; 12; 15; 107; 111	—
PRIMARY Number of "Off-protocol" Transfusions	3; 22	—
PRIMARY Change in Recipient Hemoglobin	2.6; 2.3	—
PRIMARY Change in Recipient Cell Free Hemoglobin(CFH)	22.8; 23	—
PRIMARY Change in Haptoglobin	-48.5; -54	—
SECONDARY Duration of Mechanical Ventilation	10.3; 10.8	—
SECONDARY Duration of Oxygen Supplementation	84.7; 89.5	—
SECONDARY Sequential Organ Failure Assessment (SOFA) Score	12; 13	—
SECONDARY Hospital Length of Stay	12; 12	—
SECONDARY Post Transfusion Respiratory Complications.	7; 5; 1; 0	—

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
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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02094118). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.