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VO2 Max: In Vivo Model for Functional Red Cell Testing. Can RECESS be Explained?

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ClinicalTrials.gov Identifier: NCT02918851
Recruitment Status : Recruiting
First Posted : September 29, 2016
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
Elliott Bennett-Guerrero, Stony Brook University

Brief Summary:

This is a single-center, randomized, partially blinded study to determine whether 42-day old red blood cells (RBCs) deliver oxygen as effectively as 7-day old RBCs and also to determine whether transfusion with 28-day old RBCs is non-inferior to 7-day old RBCs with respect to oxygen delivery.

In this study, subjects will be randomized to be transfused with 2 units of autologous (one's own) RBCs that are either 7-, 28-, or 42-days old. Endpoints include changes in exercise duration and VO2 max (test of oxygen consumption/delivery) between groups.


Condition or disease Intervention/treatment Phase
Healthy Biological: Transfusion of 7-day stored red blood cells Biological: Transfusion of 28-day stored red blood cells Biological: Transfusion of 42-day stored red blood cells Phase 4

Detailed Description:

The US Food and Drug Administration (FDA) regulations permit additive-containing RBCs to be stored for up to 42 days prior to transfusion. However, RBCs progressively develop abnormalities during storage. The efficacy of older stored blood, i.e., effective oxygen delivery, has not been established in rigorous controlled studies. Due to pragmatic reasons, a large clinical trial that randomizes patients to "old" blood may not be feasible.

Every subject will have 2 phlebotomy visits at Stony Brook University Hospital. Subjects randomized to the 7- and 42-day old groups will have 2 units of blood removed at Week 0 and another 2 units removed at Week 5. However, the remaining 28-day group will have 2 units of blood removed at Week 2 and only 1 unit of blood removed at Week 5. During week 6, each subjects will have 3 study visits: 1) On Monday, a VO2 max test; 2) On Wednesday, a transfusion with 2 units of autologous RBCs (each over 1 hour), followed by a VO2 max test 2 hours later; 3) On Friday, a VO2 max test will be done in order to calculate a delta VO2 max (Friday minus Monday results).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: VO2 Max: In Vivo Model for Functional Red Cell Testing. Can RECESS be Explained?
Actual Study Start Date : January 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
Experimental: 7-day old RBCs
Transfusion of 7-day stored red blood cells: Subjects will be transfused with their own 7-day old red blood cells
Biological: Transfusion of 7-day stored red blood cells
Subjects will donate blood at Week 0 and Week 5 of their participation and receive, at Week 6, back a transfusion of their Week 5 (7-day old) red blood cells.

Experimental: 28-day old RBCs
Transfusion of 28-day stored red blood cells: Subjects will be transfused with their own 28-day old red blood cells
Biological: Transfusion of 28-day stored red blood cells
Subjects will donate blood at Week 2 and Week 5 of their participation and receive, at Week 6, back a transfusion of their Week 2 (28-day old) red blood cells.

Experimental: 42-day old RBCs
Transfusion of 42-day stored red blood cells: Subjects will be transfused with their own 42-day old red blood cells
Biological: Transfusion of 42-day stored red blood cells
Subjects will donate blood at Week 0 and Week 5 of their participation and receive, at Week 6, back a transfusion of their Week0 (42-day old) red blood cells.




Primary Outcome Measures :
  1. Change in maximal oxygen uptake (VO2 max) [ Time Frame: 5-20 minutes into standardized exercise protocol, at week 6 ]
    Maximal oxygen uptake (VO2 max) is the maximum rate at which the body can consume and use oxygen, calculated via exhaustion from exercise on a treadmill or cycle ergometer with direct measurement of O2 consumption using a metabolic cart to analyze inspired and expired gases. The primary outcomes of this study are the change in VO2 max from Monday to Friday of week 6, after receiving 7-, 28-, or 42-day old blood on the Wednesday of Week 6.


Secondary Outcome Measures :
  1. Change in duration of exercise [ Time Frame: On Monday, Wednesday and Friday of week 6 ]
    This secondary outcome is the change in duration of exercise between assessments. Differences in these changes will be compared between groups



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Habitual exerciser defined as ≥ 30 minutes of at least moderate or high intensity exercise ≥ 3 times per week. After consent, and at the subsequent screening visit, a VO2 max test will be performed, and subjects with a low value (< 35 mL/kg/min) will be excluded (screen failure). Based on our previous experience, we anticipate that <10% of the subjects will fall into this category
  • Calculated total blood volume (TBV) ≥4,500 mL using an established formula:

    1. Men: (0.006012 x H3) + (14.6 x W) + 604 = TBV
    2. Women: (0.005835 x H3) + (15 x W) + 183 = TBV [H=height in inches; W=weight in pounds]
  • Has access to transportation to visit the blood collection facility and to return to Stony Brook for all study visits.

Exclusion Criteria:

  • Any significant acute or chronic medical illness or problem, including, but not limited to, diabetes, hypertension, cardiac disease, asthma, chronic obstructive lung disease
  • Current or recent (last 60 days) tobacco or nicotine use
  • History of sickle cell trait or disease or any other acquired or hereditary hematological abnormality
  • History of fainting or other significant adverse reaction during phlebotomy or donation of blood
  • Known prolonged QTc (or evidence of such at screening) on electrocardiogram defined as >470 ms
  • Known or suspected illicit drug or alcohol abuse
  • Known or suspected HIV, Hepatitis B, or Hepatitis C infection
  • History of thrombophilia or anticoagulant therapy
  • Pregnancy
  • Obesity defined as BMI>30
  • Recent history of blood donation: a) Single whole blood unit donation within the past 8 weeks; b) Double RBC donation by apheresis within the past 16 weeks; or c) Plasma donation by apheresis within the past 4 weeks
  • Inadequate RBC mass based on TBV <4500 ml (above) or screening Hb <14 g/dL

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02918851


Contacts
Contact: Sabeen Rizwan 6316381214 sabeen.rizwan@stonybrookmedicine.edu

Locations
United States, New York
Stony Brook Medicine Recruiting
Stony Brook, New York, United States, 11794-8480
Contact: Elliott Bennett-Guerrero, MD    631-444-6026    elliott.bennett-guerrero@stonybrookmedicine.edu   
Sponsors and Collaborators
Stony Brook University
Investigators
Principal Investigator: Elliott Bennett-Guerrero, MD Stony Brook University

Responsible Party: Elliott Bennett-Guerrero, Professor and Vice Chairman, Stony Brook University
ClinicalTrials.gov Identifier: NCT02918851     History of Changes
Other Study ID Numbers: 953865
First Posted: September 29, 2016    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No