Trial Outcomes & Findings for Adverse Effects of Red Blood Cell Transfusions: A Unifying Hypothesis (Aim 3) (NCT NCT02280655)

Results Overview

Ultrasonography of the brachial artery performed at the bedside using a high-resolution 10-megahertz (MHz) ultrasound transducer before and after suprasystolic inflation of a blood pressure cuff for 5 minutes in the ipsilateral upper arm. Brachial artery FMD was calculated as (hyperemic diameter - baseline diameter)/baseline diameter × 100.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

43 participants

Primary outcome timeframe

Baseline

Results posted on

2016-04-11

Participant Flow

Subjects recruited from Emory University Hospital. 142 patients were screened and of those, 99 failed screening or were excluded.

Participant milestones

Participant milestones
Measure	Storage-aged Red Blood Cells (saRBCs) Subjects with cardiovascular disease (CVD) received a transfusion with older stored red blood cells (RBCs) units. The units had been stored for greater than 21 days. Storage-aged red blood cells (saRBCs) units: Packed RBCs units stored for greater than 21 days, with a mean storage duration of 29.6 ± 4.9 days (mean ± SD)	Fresh Red Blood Cells (RBCs) Subjects with cardiovascular disease (CVD) received a transfusion with fresh red blood cells (RBCs) units. The units had been stored for less than 14 days. Fresh red blood cells units: Packed RBCs units stored for less than 14 days, with a mean storage duration of 9.6 ± 3.9 days (mean ± SD)
Overall Study STARTED	25	18
Overall Study COMPLETED	25	18
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Adverse Effects of Red Blood Cell Transfusions: A Unifying Hypothesis (Aim 3)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Storage-aged Red Blood Cells (saRBCs) n=25 Participants Subjects with cardiovascular disease (CVD) received a transfusion with older stored red blood cells (RBCs) units. The units had been stored for greater than 21 days. Storage-aged red blood cells (saRBCs) units: Packed RBCs units stored for greater than 21 days, with a mean storage duration of 29.6 ± 4.9 days (mean ± SD)	Fresh Red Blood Cells (RBCs) n=18 Participants Subjects with cardiovascular disease (CVD) received a transfusion with fresh red blood cells (RBCs) units. The units had been stored for less than 14 days. Fresh red blood cells units: Packed RBCs units stored for less than 14 days, with a mean storage duration of 9.6 ± 3.9 days (mean ± SD)	Total n=43 Participants Total of all reporting groups
Age, Continuous	58 years STANDARD_DEVIATION 12 • n=5 Participants	60 years STANDARD_DEVIATION 15 • n=7 Participants	59 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	7 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	11 Participants n=7 Participants	24 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants	18 participants n=7 Participants	43 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Ultrasonography of the brachial artery performed at the bedside using a high-resolution 10-megahertz (MHz) ultrasound transducer before and after suprasystolic inflation of a blood pressure cuff for 5 minutes in the ipsilateral upper arm. Brachial artery FMD was calculated as (hyperemic diameter - baseline diameter)/baseline diameter × 100.

Outcome measures

Outcome measures
Measure	Storage-aged Red Blood Cells (saRBCs) n=25 Participants Subjects with cardiovascular disease (CVD) received a transfusion with older stored red blood cells (RBCs) units. The units had been stored for greater than 21 days. Storage-aged red blood cells (saRBCs) units: Packed RBCs units stored for greater than 21 days, with a mean storage duration of 29.6 ± 4.9 days (mean ± SD)	Fresh Red Blood Cells (RBCs) n=18 Participants Subjects with cardiovascular disease (CVD) received a transfusion with fresh red blood cells (RBCs) units. The units had been stored for less than 14 days. Fresh red blood cells units: Packed RBCs units stored for less than 14 days, with a mean storage duration of 9.6 ± 3.9 days (mean ± SD)
Brachial Artery Flow-mediated Dilation (FMD) After Fresh Red Blood Cells (RBCs) Transfusions vs. Storage-aged Red Blood Cells (saRBCs) Transfusions at Baseline	4.87 percentage of brachial artery diameter Standard Deviation 5.011	5.38 percentage of brachial artery diameter Standard Deviation 6.5

PRIMARY outcome

Timeframe: 24 hours after transfusion

Ultrasonography of the brachial artery performed at the bedside using a high-resolution 10-megahertz (MHz) ultrasound transducer before and after suprasystolic inflation of a blood pressure cuff for 5 minutes in the ipsilateral upper arm. Brachial artery FMD was calculated as (hyperemic diameter -24 hour diameter)/24 hour diameter × 100.

Outcome measures

Outcome measures
Measure	Storage-aged Red Blood Cells (saRBCs) n=25 Participants Subjects with cardiovascular disease (CVD) received a transfusion with older stored red blood cells (RBCs) units. The units had been stored for greater than 21 days. Storage-aged red blood cells (saRBCs) units: Packed RBCs units stored for greater than 21 days, with a mean storage duration of 29.6 ± 4.9 days (mean ± SD)	Fresh Red Blood Cells (RBCs) n=18 Participants Subjects with cardiovascular disease (CVD) received a transfusion with fresh red blood cells (RBCs) units. The units had been stored for less than 14 days. Fresh red blood cells units: Packed RBCs units stored for less than 14 days, with a mean storage duration of 9.6 ± 3.9 days (mean ± SD)
Brachial Artery Flow-mediated Dilation (FMD) After Fresh Red Blood Cells (RBCs) Transfusions vs. Storage-aged Red Blood Cells (saRBCs) Transfusions at 24 Hours After Transfusion	2.47 percentage of brachial artery diameter Standard Deviation 4.88	4.7 percentage of brachial artery diameter Standard Deviation 6.19

Adverse Events

Storage-aged Red Blood Cells (saRBCs)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Fresh Red Blood Cells (RBCs)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. John D. Roback

Emory University

Phone: 404-712-1774

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place