Study Stopped
Difficulties in recruiting.
Physiologic Effects of RBC Transfusion
Physiologic Effects of RBC Storage in Chronic Transfusion Recipients: Vasoreactivity, Exercise Capacity, and Oxygen Consumption
1 other identifier
interventional
15
1 country
1
Brief Summary
The purpose of this study is to determine how red blood cell transfusions, particularly the length of storage time of units of packed red blood cells, affects the cardiovascular function in patients receiving transfusions. This study will also determine the most ideal way of storing and processing blood, and assess how transfusion affects a person's ability to exercise and how their blood vessels relax and contract.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jul 2013
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 1, 2015
CompletedFirst Posted
Study publicly available on registry
October 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2018
CompletedResults Posted
Study results publicly available
May 24, 2019
CompletedMay 24, 2019
May 1, 2019
4.7 years
October 1, 2015
March 29, 2019
May 3, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Flow-mediated Vasodilation (FMD)
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.
Baseline (prior to transfusion), Day 1 (first post-transfusion day)
Change in Reactive Hyperemic Index (RHI)
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.
Baseline (prior to transfusion), Day 1 (first post-transfusion day)
Secondary Outcomes (9)
Maximal Oxygen Uptake (VO2Max)
Day 1 (first post-transfusion day)
Respiratory Exchange Ratio (RER):
Day 1 (first post-transfusion day)
O2 Pulse
Day 1 (first post-transfusion day)
Peak VO2 Lean
Day 1 (first post-transfusion day)
Change in Oxidative Stress Markers
Baseline (prior to transfusion), Day 1 (first post-transfusion day)
- +4 more secondary outcomes
Study Arms (2)
Fresh RBC transfusion/Storage-aged RBC transfusion
ACTIVE COMPARATORSubjects will receive a transfusion of packed red blood cell (RBC) units of fresh blood (\<10 days old) followed by a transfusion of packed RBC units of storage-aged (\>21 days old) blood.
Storage-aged RBC transfusion/Fresh RBC transfusion
ACTIVE COMPARATORSubjects will receive a transfusion of packed red blood cell (RBC) units of storage-aged (\>21 days old) blood followed by a transfusion of packed RBC units of fresh blood (\<10 days old).
Interventions
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.
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.
A programmable, electronic infusion pump (Baxter, Inc) will be used for intravenous transfusion of units of packed red blood cells (RBC). The pump will be programmed to deliver 1 unit of packed RBC per hour.
Eligibility Criteria
You may qualify if:
- \- Subjects with any condition resulting in transfusion-dependent anemia
You may not qualify if:
- Age \<21 or \>80 years
- Pregnancy
- Acute infection in previous 4 weeks
- Active substance abuse within the past year
- Inability to give informed consent
- Inability to return for follow-up
- The presence of alloantibodies that would limit the blood bank's ability to obtain correctly aged red blood cell (RBC) units
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Emory Universitylead
Study Sites (1)
Emory University Hospital
Atlanta, Georgia, 30322, United States
Related Publications (1)
Radford M, Estcourt LJ, Sirotich E, Pitre T, Britto J, Watson M, Brunskill SJ, Fergusson DA, Doree C, Arnold DM. Restrictive versus liberal red blood cell transfusion strategies for people with haematological malignancies treated with intensive chemotherapy or radiotherapy, or both, with or without haematopoietic stem cell support. Cochrane Database Syst Rev. 2024 May 23;5(5):CD011305. doi: 10.1002/14651858.CD011305.pub3.
PMID: 38780066DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Arshed A. Quyyumi
- Organization
- Emory University
Study Officials
- PRINCIPAL INVESTIGATOR
Arshed Quyyumi, MD, FACC
Emory University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 1, 2015
First Posted
October 2, 2015
Study Start
July 1, 2013
Primary Completion
March 1, 2018
Study Completion
March 1, 2018
Last Updated
May 24, 2019
Results First Posted
May 24, 2019
Record last verified: 2019-05