Trial Outcomes & Findings for Adverse Effects of RBC Transfusions: A Unifying Hypothesis (NCT NCT00838331)

Last Updated: 2015-03-06

Results Overview

The primary outcome measures are changes in forearm blood flow (FBF) in recipients of fresh or stored RBC transfusions in response to acetylcholine. Secondary measures include changes in FBF with acetylcholine with or without L-NMMA, and changes in FBF with forearm exercise. In addition, flow mediated dilation (FMD) measurements will also be used to assess changes in brachial artery diameter before and after fresh vs aged RBC transfusions.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

24 participants

Primary outcome timeframe

5 years

Results posted on

2015-03-06

Participant Flow

Seven subjects withdrew prior to transfusion.

Participant milestones

Participant milestones
Measure	Fresh Blood, Then Aged Blood Subjects donated one unit of blood, which was processed, stored for 3-5 days, then infused back to the subject (Fresh Blood). At least 8 weeks later, they returned, donated another unit of blood, which was stored for 40-42 days, then infused back to the subject (Aged Blood). Before and after each transfusion, the subjects was tested with a variety of methods to assess their blood vessel function.
Fresh Blood Transfusion STARTED	17
Fresh Blood Transfusion COMPLETED	17
Fresh Blood Transfusion NOT COMPLETED	0
Aged Blood Transfusion STARTED	17
Aged Blood Transfusion COMPLETED	8
Aged Blood Transfusion NOT COMPLETED	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Fresh Blood, Then Aged Blood Subjects donated one unit of blood, which was processed, stored for 3-5 days, then infused back to the subject (Fresh Blood). At least 8 weeks later, they returned, donated another unit of blood, which was stored for 40-42 days, then infused back to the subject (Aged Blood). Before and after each transfusion, the subjects was tested with a variety of methods to assess their blood vessel function.
Aged Blood Transfusion Withdrawal by Subject	9

Baseline Characteristics

Adverse Effects of RBC Transfusions: A Unifying Hypothesis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Subjects n=8 Participants Subjects donated one unit of blood, which was processed, stored for 3-5 days, then infused back to the subject (Fresh Blood). At least 8 weeks later, they returned, donated another unit of blood, which was stored for 40-42 days, then infused back to the subject (Aged Blood). Before and after each transfusion, the subjects was tested with a variety of methods to assess their blood vessel function.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age, Continuous	26.6 years STANDARD_DEVIATION 3.4 • n=93 Participants
Sex: Female, Male Female	3 Participants n=93 Participants
Sex: Female, Male Male	5 Participants n=93 Participants
Race/Ethnicity, Customized Caucasian	4 participants n=93 Participants
Race/Ethnicity, Customized African-American	1 participants n=93 Participants
Race/Ethnicity, Customized Asian-American	2 participants n=93 Participants
Race/Ethnicity, Customized "Other"	1 participants n=93 Participants
Region of Enrollment United States	8 participants n=93 Participants

PRIMARY outcome

Timeframe: 5 years

Outcome measures

Outcome measures
Measure	Fresh Blood, Then Aged Blood n=8 Participants Subjects donated one unit of blood, which was processed, stored for 3-5 days, then infused back to the subject (Fresh Blood). At least 8 weeks later, they returned, donated another unit of blood, which was stored for 40-42 days, then infused back to the subject (Aged Blood). Before and after each transfusion, the subjects was tested with a variety of methods to assess their blood vessel function.
The Effects of Storage-related RBC Changes on Acetylcholine-stimulated (NO-mediated) Forearm Blood Flow. Prior to transfusion; fresh blood	19.02 mL / 100 mL / min Standard Deviation 8.22
The Effects of Storage-related RBC Changes on Acetylcholine-stimulated (NO-mediated) Forearm Blood Flow. Prior to transfusion; aged blood	18.42 mL / 100 mL / min Standard Deviation 4.73
The Effects of Storage-related RBC Changes on Acetylcholine-stimulated (NO-mediated) Forearm Blood Flow. Immediately after transfusion; fresh blood	17.61 mL / 100 mL / min Standard Deviation 4.8
The Effects of Storage-related RBC Changes on Acetylcholine-stimulated (NO-mediated) Forearm Blood Flow. Immediately after transfusion; aged blood	22.89 mL / 100 mL / min Standard Deviation 5.52
The Effects of Storage-related RBC Changes on Acetylcholine-stimulated (NO-mediated) Forearm Blood Flow. 24 hours after transfusion; fresh blood	22.83 mL / 100 mL / min Standard Deviation 19.66
The Effects of Storage-related RBC Changes on Acetylcholine-stimulated (NO-mediated) Forearm Blood Flow. 24 hours after transfusion; aged blood	19.66 mL / 100 mL / min Standard Deviation 3.62

Adverse Events

All Subjects

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

John Roback, MD PhD

Emory University

Phone: 404-712-1774

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place