Difficulties in recruiting.
Physiologic Effects of RBC Storage in Chronic Transfusion Recipients: Vasoreactivity, Exercise Capacity, and Oxygen Consumption
Sponsor study identifier
interventional
15
1 country
1
Study Start
July 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2018
Actual (reported)Study Completion
March 2018
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2013
Date type not reportedThis date has not been verified as actual or estimated.
October 1, 2015
Actual (reported)October 2, 2015
Actual (reported)March 2018
Actual (reported)March 2018
Actual (reported)May 24, 2019
Actual (reported)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)
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)
Subjects 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.
Subjects 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).
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.
Emory University Hospital
Atlanta, Georgia, 30322, United States
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.
Arshed Quyyumi, MD, FACC
Emory University
15 participants (actual enrollment reported by the registry).
First Submitted
October 1, 2015
First Posted
October 2, 2015
Study Start
July 2013
Date type not reportedThis date has not been verified as actual or estimated.
Evaluation of Two Epoetin Alfa Dosing Strategies in Subjects With Chronic Kidney Disease Receiving Hemodialysis
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
March 2018
Actual (reported)Study Completion
March 2018
Actual (reported)Last Updated
May 24, 2019
Results First Posted
May 24, 2019
Record last verified: 2019-05
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Source: ClinicalTrials.gov.
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