Trial Outcomes & Findings for Point-of-Care RBC Washing to Prevent Transfusion-Related Pulmonary Complications (NCT NCT02094118)
NCT ID: NCT02094118
Last Updated: 2021-04-06
Results Overview
This panel of biomarkers measures inflammation, altered coagulation, and endothelial activation all of which play key roles in the pathogenesis of lung injury.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
171 participants
Primary outcome timeframe
18 hours after the initiation of the first red blood cell transfusion.
Results posted on
2021-04-06
Participant Flow
Participant milestones
| Measure |
Standard of Care Red Blood Cell Transfusion
Red blood cells that are administered as standard of care.
Standard of care red blood cell transfusion.
|
Point-of-Care Washed Red Blood Cell Transfusion
Red blood cells that are washed at the point-of-care.
Point-of-care washed red blood cell transfusion.
|
|---|---|---|
|
Overall Study
STARTED
|
85
|
86
|
|
Overall Study
COMPLETED
|
73
|
81
|
|
Overall Study
NOT COMPLETED
|
12
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Point-of-Care RBC Washing to Prevent Transfusion-Related Pulmonary Complications
Baseline characteristics by cohort
| Measure |
Standard of Care Red Blood Cell Transfusion
n=85 Participants
Red blood cells that are administered in the normal fashion.
Standard of care red blood cell transfusion.
|
Point-of-Care Washed Red Blood Cell Transfusion
n=86 Participants
Red blood cells that are washed at the point-of-care.
Point-of-care washed red blood cell transfusion.
|
Total
n=171 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.1 years
STANDARD_DEVIATION 11.4 • n=99 Participants
|
65.0 years
STANDARD_DEVIATION 12.1 • n=107 Participants
|
65.6 years
STANDARD_DEVIATION 11.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
84 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
87 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
81 Participants
n=99 Participants
|
78 Participants
n=107 Participants
|
159 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
66 Participants
n=99 Participants
|
64 Participants
n=107 Participants
|
130 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
85 participants
n=99 Participants
|
86 participants
n=107 Participants
|
171 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 18 hours after the initiation of the first red blood cell transfusion.Population: Patients undergoing cardiac surgery who were predicted to be at high risk for requiring red blood cell transfusion.
This panel of biomarkers measures inflammation, altered coagulation, and endothelial activation all of which play key roles in the pathogenesis of lung injury.
Outcome measures
| Measure |
Standard of Care Red Blood Cell Transfusion
n=73 Participants
Red blood cells transfusion that were administered in the standard of care
|
Point-of-Care Washed Red Blood Cell Transfusion
n=81 Participants
Red blood cells transfusion that were washed at the point-of-care.
|
|---|---|---|
|
Biomarkers Associated With Transfusion-Related Acute Lung Injury and Transfusion Associated Circulatory Overload.
vWF
|
107 units on a scale (pg/ml)
Interval 84.0 to 137.0
|
111 units on a scale (pg/ml)
Interval 74.0 to 142.0
|
|
Biomarkers Associated With Transfusion-Related Acute Lung Injury and Transfusion Associated Circulatory Overload.
RAGE
|
3262 units on a scale (pg/ml)
Interval 2326.0 to 6899.0
|
4516 units on a scale (pg/ml)
Interval 2354.0 to 5907.0
|
|
Biomarkers Associated With Transfusion-Related Acute Lung Injury and Transfusion Associated Circulatory Overload.
SP_D
|
7238 units on a scale (pg/ml)
Interval 4962.0 to 11900.0
|
7061 units on a scale (pg/ml)
Interval 4470.0 to 13318.0
|
|
Biomarkers Associated With Transfusion-Related Acute Lung Injury and Transfusion Associated Circulatory Overload.
PAI_1
|
73418 units on a scale (pg/ml)
Interval 38900.0 to 196491.0
|
53829 units on a scale (pg/ml)
Interval 21044.0 to 151009.0
|
|
Biomarkers Associated With Transfusion-Related Acute Lung Injury and Transfusion Associated Circulatory Overload.
IL-6
|
101 units on a scale (pg/ml)
Interval 57.0 to 197.0
|
105 units on a scale (pg/ml)
Interval 70.0 to 191.0
|
|
Biomarkers Associated With Transfusion-Related Acute Lung Injury and Transfusion Associated Circulatory Overload.
IL-8
|
12 units on a scale (pg/ml)
Interval 6.0 to 23.0
|
15 units on a scale (pg/ml)
Interval 7.0 to 26.0
|
|
Biomarkers Associated With Transfusion-Related Acute Lung Injury and Transfusion Associated Circulatory Overload.
ICAM_1
|
404914 units on a scale (pg/ml)
Interval 313796.0 to 513060.0
|
404129 units on a scale (pg/ml)
Interval 309411.0 to 538055.0
|
PRIMARY outcome
Timeframe: Day of surgery. Approximately 1 day.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.
Outcome measures
| Measure |
Standard of Care Red Blood Cell Transfusion
n=73 Participants
Red blood cells transfusion that were administered in the standard of care
|
Point-of-Care Washed Red Blood Cell Transfusion
n=81 Participants
Red blood cells transfusion that were washed at the point-of-care.
|
|---|---|---|
|
Number of "Off-protocol" Transfusions
|
3 transfusions
|
22 transfusions
|
PRIMARY outcome
Timeframe: Pre to 6 hours post transfusionChange in Hemoglobin from pre-transfusion to post-transfusion
Outcome measures
| Measure |
Standard of Care Red Blood Cell Transfusion
n=73 Participants
Red blood cells transfusion that were administered in the standard of care
|
Point-of-Care Washed Red Blood Cell Transfusion
n=81 Participants
Red blood cells transfusion that were washed at the point-of-care.
|
|---|---|---|
|
Change in Recipient Hemoglobin
|
2.6 units on a scale (g/dl)
Interval 1.6 to 3.6
|
2.3 units on a scale (g/dl)
Interval 1.4 to 3.1
|
PRIMARY outcome
Timeframe: Pre transfusion until study day 5 or hospital discharge, approximately 5 daysChange in CFH from pre-transfusion to worst (highest/maximum) post-transfusion
Outcome measures
| Measure |
Standard of Care Red Blood Cell Transfusion
n=73 Participants
Red blood cells transfusion that were administered in the standard of care
|
Point-of-Care Washed Red Blood Cell Transfusion
n=81 Participants
Red blood cells transfusion that were washed at the point-of-care.
|
|---|---|---|
|
Change in Recipient Cell Free Hemoglobin(CFH)
|
22.8 units on a scale (mg/dl)
Interval 8.9 to 52.0
|
23 units on a scale (mg/dl)
Interval 6.6 to 58.4
|
PRIMARY outcome
Timeframe: Pre transfusion to study day 5 or hospital discharge, approximately 5 daysChange in Haptoglobin from pre-transfusion to worst (minimum) post-transfusion
Outcome measures
| Measure |
Standard of Care Red Blood Cell Transfusion
n=73 Participants
Red blood cells transfusion that were administered in the standard of care
|
Point-of-Care Washed Red Blood Cell Transfusion
n=81 Participants
Red blood cells transfusion that were washed at the point-of-care.
|
|---|---|---|
|
Change in Haptoglobin
|
-48.5 units on a scale (mg/dl)
Interval -95.0 to -16.5
|
-54 units on a scale (mg/dl)
Interval -103.0 to -7.0
|
SECONDARY outcome
Timeframe: Up to hospital day 28, or discharge, whichever comes firstNumber of hours subject received mechanical ventilation.
Outcome measures
| Measure |
Standard of Care Red Blood Cell Transfusion
n=73 Participants
Red blood cells transfusion that were administered in the standard of care
|
Point-of-Care Washed Red Blood Cell Transfusion
n=81 Participants
Red blood cells transfusion that were washed at the point-of-care.
|
|---|---|---|
|
Duration of Mechanical Ventilation
|
10.3 units on a scale (hours)
Interval 5.6 to 23.5
|
10.8 units on a scale (hours)
Interval 5.6 to 20.1
|
SECONDARY outcome
Timeframe: Up to day 28, or hospital discharge, whichever comes firstNumber of hours subjects received supplemental oxygen.
Outcome measures
| Measure |
Standard of Care Red Blood Cell Transfusion
n=73 Participants
Red blood cells transfusion that were administered in the standard of care
|
Point-of-Care Washed Red Blood Cell Transfusion
n=81 Participants
Red blood cells transfusion that were washed at the point-of-care.
|
|---|---|---|
|
Duration of Oxygen Supplementation
|
84.7 units on a scale (hours)
Interval 45.5 to 142.7
|
89.5 units on a scale (hours)
Interval 39.9 to 180.4
|
SECONDARY outcome
Timeframe: Through postoperative day 5.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.
Outcome measures
| Measure |
Standard of Care Red Blood Cell Transfusion
n=73 Participants
Red blood cells transfusion that were administered in the standard of care
|
Point-of-Care Washed Red Blood Cell Transfusion
n=81 Participants
Red blood cells transfusion that were washed at the point-of-care.
|
|---|---|---|
|
Sequential Organ Failure Assessment (SOFA) Score
|
12 units on a scale
Interval 10.0 to 14.0
|
13 units on a scale
Interval 11.0 to 14.0
|
SECONDARY outcome
Timeframe: Up to day 28Number 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.
Outcome measures
| Measure |
Standard of Care Red Blood Cell Transfusion
n=73 Participants
Red blood cells transfusion that were administered in the standard of care
|
Point-of-Care Washed Red Blood Cell Transfusion
n=81 Participants
Red blood cells transfusion that were washed at the point-of-care.
|
|---|---|---|
|
Hospital Length of Stay
|
12 units on a scale (days)
Interval 9.0 to 17.0
|
12 units on a scale (days)
Interval 9.0 to 17.0
|
SECONDARY outcome
Timeframe: Up to day 28Development of transfusion-related lung injury (TRALI) or transfusion-associated circulatory overload (TACO).
Outcome measures
| Measure |
Standard of Care Red Blood Cell Transfusion
n=73 Participants
Red blood cells transfusion that were administered in the standard of care
|
Point-of-Care Washed Red Blood Cell Transfusion
n=81 Participants
Red blood cells transfusion that were washed at the point-of-care.
|
|---|---|---|
|
Post Transfusion Respiratory Complications.
TACO
|
7 participants
|
5 participants
|
|
Post Transfusion Respiratory Complications.
TRALI
|
1 participants
|
0 participants
|
Adverse Events
Standard of Care Red Blood Cell Transfusion
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Point-of-Care Washed Red Blood Cell Transfusion
Serious events: 7 serious events
Other events: 0 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Standard of Care Red Blood Cell Transfusion
n=85 participants at risk
Red blood cells transfusion that were administered in the standard of care
|
Point-of-Care Washed Red Blood Cell Transfusion
n=86 participants at risk
Red blood cells transfusion that were washed at the point-of-care.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
hypoxemia
|
0.00%
0/85 • From randomization to hospital discharge, death, or day 28 (whichever occurs first).
|
2.3%
2/86 • Number of events 2 • From randomization to hospital discharge, death, or day 28 (whichever occurs first).
|
|
Blood and lymphatic system disorders
Profound Anemia
|
0.00%
0/85 • From randomization to hospital discharge, death, or day 28 (whichever occurs first).
|
2.3%
2/86 • Number of events 2 • From randomization to hospital discharge, death, or day 28 (whichever occurs first).
|
|
Renal and urinary disorders
Hyperkalemia
|
0.00%
0/85 • From randomization to hospital discharge, death, or day 28 (whichever occurs first).
|
2.3%
2/86 • Number of events 2 • From randomization to hospital discharge, death, or day 28 (whichever occurs first).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/85 • From randomization to hospital discharge, death, or day 28 (whichever occurs first).
|
1.2%
1/86 • Number of events 1 • From randomization to hospital discharge, death, or day 28 (whichever occurs first).
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place