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

NCT02918851 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 953865
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Percent Change From Baseline in Maximal Oxygen Uptake (VO2 Max) After Blood Cell Transfusion

  Percent Change From Baseline in Maximal Oxygen Uptake (VO2 Max) on Day 2 After Blood Cell Transfusion

  Baseline (prior to receiving blood) and Day 2 after receiving blood

Secondary Outcomes (1)

• Percent Change in Duration of Exercise From Baseline to Day 2 After RBC Transfusion

  Baseline and Day 2 after transfusion

Study Arms (3)

7-day old RBCs

EXPERIMENTAL

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

28-day old RBCs

EXPERIMENTAL

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

42-day old RBCs

EXPERIMENTAL

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

Interventions

Transfusion of 7-day stored red blood cells BIOLOGICAL

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.

7-day old RBCs

Transfusion of 28-day stored red blood cells BIOLOGICAL

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.

28-day old RBCs

Transfusion of 42-day stored red blood cells BIOLOGICAL

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.

42-day old RBCs

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• Men: (0.006012 x H3) + (14.6 x W) + 604 = TBV
• 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.

You may not qualify if:

• 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 corrected QT interval (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

Sponsors & Collaborators

• Stony Brook University: lead

Study Sites (1)

Stony Brook Medicine

Stony Brook, New York, 11794-8480, United States

Location

Related Publications (1)

• Bennett-Guerrero E, Rizwan S, Rozensky R, Romeiser JL, Brittelli J, Makaryus R, Lin J, Galanakis DK, Triulzi DJ, Moon RE. Randomized controlled trial of 7, 28, vs 42 day stored red blood cell transfusion on oxygen delivery (VO2 max) and exercise duration. Transfusion. 2021 Mar;61(3):699-707. doi: 10.1111/trf.16237. Epub 2020 Dec 27.

  PMID: 33368319 DERIVED

Results Point of Contact

• Title: Dr. Elliott Bennett-Guerrero
• Organization: Stony Brook Medicine

elliott.bennett-guerrero@stonybrookmedicine.edu

6314442979

Study Officials

• Elliott Bennett-Guerrero, MD

  Stony Brook University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Vice Chairman

Study Record Dates

• First Submitted: September 27, 2016
• First Posted: September 29, 2016
• Study Start: January 1, 2017
• Primary Completion: August 9, 2019
• Study Completion: November 20, 2019
• Last Updated: April 8, 2021
• Results First Posted: February 11, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)