Trial Outcomes & Findings for Physiologic Effects of RBC Transfusion (NCT NCT02566577)
NCT ID: NCT02566577
Last Updated: 2019-05-24
Results Overview
Brachial artery flow-mediated dilation (FMD) will be performed by using ultrasonography. The brachial artery of the non-dominant arm will be imaged using a high-resolution 13 MHz ultrasound transducer. A blood pressure cuff on the forearm will be inflated to supra-systolic pressures to produce 5 minutes of ischemia. After cuff deflation, imaging of the brachial artery will be performed continuously for the next 120 seconds and the flow-mediated dilation will be calculated. Change in FMD is the percent change in the diameter of the brachial artery from baseline (prior to transfusion) to Day 1 (first post-transfusion day). A higher FMD indicates better nitric oxide-dependent endothelial function.
TERMINATED
PHASE4
15 participants
Baseline (prior to transfusion), Day 1 (first post-transfusion day)
2019-05-24
Participant Flow
Participant milestones
| Measure |
Fresh RBC Transfusion/Storage-aged RBC Transfusion
Fresh red blood cell (RBC) transfusion: 1 or 2 cross-matched, packed red blood cells (RBC) units from fresh (\<10 days old) blood, as ordered by the attending physician, will be given as an intravenous infusion via a programmable electronic infusion pump (Baxter, Inc) over a period of 1 hour per unit.
Storage-aged red blood cell (RBC) transfusion: 1 or 2 cross-matched, packed red blood cells (RBC) units from storage-aged (\>21 days old) blood, as ordered by the attending physician, will be given as an intravenous infusion via a programmable electronic infusion pump (Baxter, Inc) over a period of 1 hour per unit.
|
Storage-aged RBC Transfusion/Fresh RBC Transfusion
Storage-aged red blood cell (RBC) transfusion: 1 or 2 cross-matched, packed red blood cells (RBC) units from storage-aged (\>21 days old) blood, as ordered by the attending physician, will be given as an intravenous infusion via a programmable electronic infusion pump (Baxter, Inc) over a period of 1 hour per unit.
Fresh red blood cell (RBC) transfusion: 1 or 2 cross-matched, packed red blood cells (RBC) units from fresh (\<10 days old) blood, as ordered by the attending physician, will be given as an intravenous infusion via a programmable electronic infusion pump (Baxter, Inc) over a period of 1 hour per unit.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
6
|
|
Overall Study
COMPLETED
|
6
|
4
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
Fresh RBC Transfusion/Storage-aged RBC Transfusion
Fresh red blood cell (RBC) transfusion: 1 or 2 cross-matched, packed red blood cells (RBC) units from fresh (\<10 days old) blood, as ordered by the attending physician, will be given as an intravenous infusion via a programmable electronic infusion pump (Baxter, Inc) over a period of 1 hour per unit.
Storage-aged red blood cell (RBC) transfusion: 1 or 2 cross-matched, packed red blood cells (RBC) units from storage-aged (\>21 days old) blood, as ordered by the attending physician, will be given as an intravenous infusion via a programmable electronic infusion pump (Baxter, Inc) over a period of 1 hour per unit.
|
Storage-aged RBC Transfusion/Fresh RBC Transfusion
Storage-aged red blood cell (RBC) transfusion: 1 or 2 cross-matched, packed red blood cells (RBC) units from storage-aged (\>21 days old) blood, as ordered by the attending physician, will be given as an intravenous infusion via a programmable electronic infusion pump (Baxter, Inc) over a period of 1 hour per unit.
Fresh red blood cell (RBC) transfusion: 1 or 2 cross-matched, packed red blood cells (RBC) units from fresh (\<10 days old) blood, as ordered by the attending physician, will be given as an intravenous infusion via a programmable electronic infusion pump (Baxter, Inc) over a period of 1 hour per unit.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Equipment failure
|
1
|
1
|
|
Overall Study
Physical limitation
|
1
|
0
|
Baseline Characteristics
Physiologic Effects of RBC Transfusion
Baseline characteristics by cohort
| Measure |
Fresh RBC Transfusion/Storage-aged RBC Transfusion
n=9 Participants
Fresh red blood cell (RBC) transfusion: 1 or 2 cross-matched, packed red blood cells (RBC) units from fresh (\<10 days old) blood, as ordered by the attending physician, will be given as an intravenous infusion via a programmable electronic infusion pump (Baxter, Inc) over a period of 1 hour per unit.
|
Storage-aged RBC Transfusion/Fresh RBC Transfusion
n=6 Participants
Storage-aged red blood cell (RBC) transfusion: 1 or 2 cross-matched, packed red blood cells (RBC) units from storage-aged (\>21 days old) blood, as ordered by the attending physician, will be given as an intravenous infusion via a programmable electronic infusion pump (Baxter, Inc) over a period of 1 hour per unit.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=93 Participants
|
6 participants
n=4 Participants
|
15 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline (prior to transfusion), Day 1 (first post-transfusion day)Population: The data are not stratified by data points/study periods, as the data points were not collected due to non-compliant nature of the enrolled subjects. Majority of the subjects did not complete the study entirety.
Brachial artery flow-mediated dilation (FMD) will be performed by using ultrasonography. The brachial artery of the non-dominant arm will be imaged using a high-resolution 13 MHz ultrasound transducer. A blood pressure cuff on the forearm will be inflated to supra-systolic pressures to produce 5 minutes of ischemia. After cuff deflation, imaging of the brachial artery will be performed continuously for the next 120 seconds and the flow-mediated dilation will be calculated. Change in FMD is the percent change in the diameter of the brachial artery from baseline (prior to transfusion) to Day 1 (first post-transfusion day). A higher FMD indicates better nitric oxide-dependent endothelial function.
Outcome measures
| Measure |
Fresh RBC Transfusion/Storage-aged RBC Transfusion
n=9 Participants
Fresh red blood cell (RBC) transfusion: 1 or 2 cross-matched, packed red blood cells (RBC) units from fresh (\<10 days old) blood, as ordered by the attending physician, will be given as an intravenous infusion via a programmable electronic infusion pump (Baxter, Inc) over a period of 1 hour per unit.
Storage-aged red blood cell (RBC) transfusion: 1 or 2 cross-matched, packed red blood cells (RBC) units from storage-aged (\>21 days old) blood, as ordered by the attending physician, will be given as an intravenous infusion via a programmable electronic infusion pump (Baxter, Inc) over a period of 1 hour per unit.
|
Storage-aged RBC Transfusion/Fresh RBC Transfusion
n=6 Participants
Storage-aged red blood cell (RBC) transfusion: 1 or 2 cross-matched, packed red blood cells (RBC) units from storage-aged (\>21 days old) blood, as ordered by the attending physician, will be given as an intravenous infusion via a programmable electronic infusion pump (Baxter, Inc) over a period of 1 hour per unit.
Fresh red blood cell (RBC) transfusion: 1 or 2 cross-matched, packed red blood cells (RBC) units from fresh (\<10 days old) blood, as ordered by the attending physician, will be given as an intravenous infusion via a programmable electronic infusion pump (Baxter, Inc) over a period of 1 hour per unit.
|
|---|---|---|
|
Change in Flow-mediated Vasodilation (FMD)
|
1.83333 percentage of FMD
Standard Deviation 3.900427
|
-3.56667 percentage of FMD
Standard Deviation 6.612614
|
PRIMARY outcome
Timeframe: Baseline (prior to transfusion), Day 1 (first post-transfusion day)Population: Data were not collected. The study subjects could not complete the proposed study procedure due to preexisting comorbidities.
Reactive Hyperemia Index (RHI) will be measured using Pulsatile Arterial Tonometry (PAT). Baseline blood pressure of both hands is measured and PAT probes are placed one on each hand at the same finger (fingers 2, 3 or 4). Following an equilibration period of 10 minutes, the blood pressure cuff will be inflated to 60 mmHg above systolic pressure for 5 minutes followed by deflation of the cuff and the pulsatile recordings from both study and control fingers will be measured. RHI will be calculated from the ratio of the digital pulse volume during reactive hyperemia (following cuff deflation) and baseline. A higher RHI indicates better nitric oxide-dependent endothelial function.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 (first post-transfusion day)Population: Data were not collected. The study subjects could not complete the proposed study procedure due to preexisting comorbidities.
Subjects will undergo graded treadmill testing following American Heart Association guidelines using the modified Balke protocol. A treadmill with full metabolic cart will be used for the cardiopulmonary testing. Maximal oxygen uptake (VO2Max) is the value achieved when the oxygen uptake remains stable despite a progressive increase in the intensity of exercise. The VO2Max will be calculated from the cardiac output and the arteriovenous oxygen difference during peak exercise. VO2Max is expressed in milliliters of oxygen per minute per kilogram of body weight (ml/min/kg). A higher VO2Max indicates better vascular reactivity.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 (first post-transfusion day)Population: Data were not collected. The study subjects could not complete the proposed study procedure due to preexisting comorbidities.
Subjects will undergo graded treadmill testing following American Heart Association guidelines using the modified Balke protocol. A treadmill with full metabolic cart will be used for the cardiopulmonary testing. RER is the ratio of VCO2 (carbon dioxide output) to VO2 (oxygen uptake). A higher RER indicates better vascular reactivity.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 (first post-transfusion day)Population: Data were not collected. The study subjects could not complete the proposed study procedure due to preexisting comorbidities.
Subjects will undergo graded treadmill testing following American Heart Association guidelines using the modified Balke protocol. A treadmill with full metabolic cart will be used for the cardiopulmonary testing. O2 (oxygen) pulse is the amount of O2 consumed from the volume of blood delivered to tissues by each heartbeat; this index is calculated as: O2 pulse = VO2 / heart rate. A higher O2 pulse indicates better vascular reactivity.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 (first post-transfusion day)Population: Data were not collected. The study subjects could not complete the proposed study procedure due to preexisting comorbidities.
Subjects will undergo graded treadmill testing following American Heart Association guidelines using the modified Balke protocol. A treadmill with full metabolic cart will be used for the cardiopulmonary testing. Peak VO2 lean is the peak oxygen uptake adjusted for lean body mass and is reported as a lean body weight-adjustment parameter in mL/kg per minute.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (prior to transfusion), Day 1 (first post-transfusion day)Population: Data were not collected. The study subjects could not complete the proposed study procedure due to preexisting comorbidities.
Oxidative stress will be measured using high-performance liquid chromatography (HPLC) to collect plasma cystine, cysteine, glutathione, and glutathione disulfide levels. Higher levels of cystine, cysteine, glutathione, and glutathione disulfide indicate higher levels of vascular inflammation.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (prior to transfusion), Day 1 (first post-transfusion day)Population: Data were not collected. The study subjects could not complete the proposed study procedure due to preexisting comorbidities.
Nitric oxide metabolites like nitrite, nitrate, S-nitrosothiols (SNO-Hb and SNO-thiol) will be measured from blood samples using high-performance liquid chromatography (HPLC). Higher levels of nitric oxide metabolites indicate higher levels of nitric oxide (NO) synthesis and better vascular reactivity.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (prior to transfusion), Day 1 (first post-transfusion day)Population: Data were not collected. The study subjects could not complete the proposed study procedure due to preexisting comorbidities.
Levels of high-sensitivity C-reactive protein (hsCRP) in the blood will be measured by using Dade Behring nephelometry. Higher levels of hsCRP indicate increased vascular inflammation.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (prior to transfusion), Day 1 (first post-transfusion day)Population: Data were not collected. The study subjects could not complete the proposed study procedure due to preexisting comorbidities.
Plasma IL-6 concentration will be measured by enzyme-linked immunosorbent assay (ELISA). Change is the difference in the levels of IL-6 from baseline to Day 1 (first post-transfusion day). Higher concentrations of IL-6 indicate increased vascular inflammation.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (prior to transfusion), Day 1 (first post-transfusion day)Population: Data were not collected. The study subjects could not complete the proposed study procedure due to preexisting comorbidities.
Plasma IL-2 concentration will be measured by enzyme-linked immunosorbent assay (ELISA). Change is the difference in the levels of IL-2 from baseline to Day 1 (first post-transfusion day). Higher concentrations of IL-2 indicate increased vascular inflammation.
Outcome measures
Outcome data not reported
Adverse Events
Fresh RBC Transfusion/Storage-aged RBC Transfusion
Storage-aged RBC Transfusion/Fresh RBC Transfusion
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place