HealthyPhase 4NCT02918851

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

A Phase 4 study testing Transfusion of 7-day stored red blood cells, Transfusion of 28-day stored red blood cells and Transfusion of 42-day stored red blood cells in people with Healthy, run by Stony Brook University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Transfusion of 7-day stored red blood cells, Transfusion of 28-day stored red blood cells and Transfusion of 42-day stored red blood cells
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 42 participants
Where: 1 siteUnited States
Study dates: Jan 2017to 20 Nov 2019
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 40 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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

Show all 12Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Stony Brook Medicine
Stony Brook, New York, 11794-8480

Other trials in United States

About this study

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.

Read the 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).

Conditions: Healthy
Being tested: Transfusion of 7-day stored red blood cells, Transfusion of 28-day stored red blood cells, Transfusion of 42-day stored red blood cells

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Transfusion of 7-day stored red blood cellsBiological
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.
Transfusion of 28-day stored red blood cellsBiological
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.
Transfusion of 42-day stored red blood cellsBiological
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.

Study groups in NCT02918851
Study group	Role	What they receive
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 Receives: 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 Receives: 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 Receives: Biological: Transfusion of 42-day stored red blood cells

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Percent change in duration of exercise from baseline to day 2 after red blood cell transfusion
Measured: Baseline and Day 2 after transfusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 201720 Nov 2019

First posted29 Sep 2016 (estimated)
Study startJan 2017
Primary completion9 Aug 2019
Study completion20 Nov 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02918851
Sponsor's protocol ID: 953865
Status last verified: Mar 2021
First submitted: 27 Sep 2016
Last updated: 8 Apr 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 33368319

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
A Study of Phenytoin Mucoadhesive Film for Oral Ulcers in Healthy Volunteers
Oral Ulcer, Oral Mucositis
Not yet recruiting
SUVY VerSus SAccharose (SUVISA)
Healthy Volunteers, Erythritol
RecruitingPhase 1
A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 in Healthy Children
Seasonal Influenza
Not yet recruitingObservational study
Microneurographic Assessment of Peripheral Nerves in Healthy Volunteers and Individuals With Sensory Dysfunction Caused by Inherited Mutations in the PIEZO2 Gene
PIEZO2-Deficiency Syndrome
Enrolling by invitationObservational study
Connors Protocol for the Management and Use of Stored Human Specimens (Stored Human Specimens)
Healthy Volunteer Samples

All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: VO2 Max: In Vivo Model for Functional Red Cell Testing. Can RECESS be Explained?
ClinicalTrials.gov ID: NCT02918851
Acronym / sponsor ID: 953865
Conditions: Healthy
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: Stony Brook UniversityUniversity, hospital or other
Study start: Jan 2017 (actual)
Primary completion: 9 Aug 2019 (actual)
Study completion: 20 Nov 2019 (actual)
First posted: 29 Sep 2016 (estimated)
Results: Posted 11 Feb 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
7-day old RBCs	Experimental	Biological: Transfusion of 7-day stored red blood cellsTransfusion of 7-day stored red blood cells: Subjects will be transfused with their own 7-day old red blood cells
28-day old RBCs	Experimental	Biological: Transfusion of 28-day stored red blood cellsTransfusion of 28-day stored red blood cells: Subjects will be transfused with their own 28-day old red blood cells
42-day old RBCs	Experimental	Biological: Transfusion of 42-day stored red blood cellsTransfusion of 42-day stored red blood cells: Subjects will be transfused with their own 42-day old red blood cells

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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:
Has access to transportation to visit the blood collection facility and to return to Stony Brook for all study visits.

Key exclusion criteria (12 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Transfusion of 7-day stored red blood cellsSubjects 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.	Biological	7-day old RBCs
Transfusion of 28-day stored red blood cellsSubjects 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.	Biological	28-day old RBCs
Transfusion of 42-day stored red blood cellsSubjects 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.	Biological	42-day old RBCs

Primary outcome

Percent Change From Baseline in Maximal Oxygen Uptake (VO2 Max) After Blood Cell Transfusion
Time frame: Baseline (prior to receiving blood) and Day 2 after receiving blood
Percent Change From Baseline in Maximal Oxygen Uptake (VO2 Max) on Day 2 After Blood Cell Transfusion

1 secondary outcome

Percent Change in Duration of Exercise From Baseline to Day 2 After RBC Transfusion
Time frame: Baseline and Day 2 after transfusion

Results and safety

Results posted to the registry on 11 Feb 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
7-day Old RBCs	14	10
28-day Old RBCs	14	10
42-day Old RBCs	14	10

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

Time frame: Baseline (prior to receiving blood) and Day 2 after receiving blood. Median (Inter-Quartile Range). Unit: percent change

Measure	7-day Old RBCs n = 10	28-day Old RBCs n = 10	42-day Old RBCs n = 10
Value	10.5 (0.2 to 17.3)	8.5 (2.9 to 13.1)	10.9 (5.7 to 16.8)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: End of study an average of 2 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
7-day Old RBCs	0 of 10 (0%)	0 of 10 (0%)	0 of 10
28-day Old RBCs	0 of 10 (0%)	0 of 10 (0%)	0 of 10
42-day Old RBCs	0 of 10 (0%)	0 of 10 (0%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33368319Bennett-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.
Individual participant dataSharing planned: No

Related trials for Healthy

Not yet recruitingPhase 1
A Study of Phenytoin Mucoadhesive Film for Oral Ulcers in Healthy Volunteers
Oral Ulcer, Oral Mucositis
Not yet recruiting
SUVY VerSus SAccharose (SUVISA)
Healthy Volunteers, Erythritol
RecruitingPhase 1
A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 in Healthy Children
Seasonal Influenza
Not yet recruitingObservational study
Microneurographic Assessment of Peripheral Nerves in Healthy Volunteers and Individuals With Sensory Dysfunction Caused by Inherited Mutations in the PIEZO2 Gene
PIEZO2-Deficiency Syndrome
Enrolling by invitationObservational study
Connors Protocol for the Management and Use of Stored Human Specimens (Stored Human Specimens)
Healthy Volunteer Samples

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Elliott Bennett-Guerrero, MD principal investigator

Stony Brook University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change From Baseline in Maximal Oxygen Uptake (VO2 Max) After Blood Cell Transfusion (time frame: Baseline (prior to receiving blood) and Day 2 after receiving blood). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02918851, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.