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Outcome Measures

Primary Outcomes (2)

Change in VO2max
Change in VO2max from "anemic" (pre-transfusion) VO2max and after transfusion of 2 units of either standard PRBCs or rej-PRBCs "post-Tx" VO2max.
Day 16 to Day 18 post transfusion
Change in Lactate
Change in lactate from "anemic" (pre-transfusion) VO2max and after transfusion of 2 units of either standard PRBCs or rej-PRBCs "post-Tx" VO2max
Day 16 to Day 18 post transfusion

Secondary Outcomes (1)

Change in "Post-Tx" VO2max From Baseline
Baseline to Day 18 post transfusion

Study Arms (2)

Rejuvenated RBC Transfusion

EXPERIMENTAL

Washed and Rejuvenated autologous blood

Biological: Transfusion of rejuvenated and washed autolgous RBCs

Standard RBC Transfusion

SHAM COMPARATOR

Washed autologous blood (so as to maintain equivalent unit volume and Hct)

Biological: Transfusion of washed autolgous RBCs

Interventions

Transfusion of rejuvenated and washed autolgous RBCsBiological

Rejuvenation refers to the process of adding a mix of solutes (Rejuvesol®, Citra Labs, Braintree, MA; consists of sodium pyruvate, inosine, adenine, mono- and dibasic sodium phosphate) to older, stored (i.e., 2-3 DPG-depleted) blood to immediately restore 2,3-DPG and ATP levels in the stored red blood cells15. Rejuvenation was originally developed to prolong the storage life of rare-phenotype RBC units. It is FDA-approved for use in RBC units stored in CPD, CPDA-1, and AS-1. The major contraindication for the use of Rejuvesol® is in RBC units stored for fewer than 6 days due to high baseline 2,3-DPG and ATP levels. Rejuvenated units must be washed prior to administration to remove residual Rejuvesol that is not approved for iv administration in such concentrations.

Rejuvenated RBC Transfusion

Transfusion of washed autolgous RBCs

Eligibility Criteria

Age18 Years - 40 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Healthy male or female
Age 18-40 (the American College of Sports Medicine Guidelines for Exercise Testing defines this age group with no or no more than one coronary heart disease risk factor as low-risk for VO2 max testing)

Study Design

Study Type

interventional

Phase

phase 4

Allocation

RANDOMIZED

Masking

TRIPLE

Who Masked

PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR

Masking Details

Addition of rejuvesol will be performed by the blood bank and only they will know of group assignment

Purpose

BASIC SCIENCE

Intervention Model

PARALLEL

Model Details: Prospective randomized "healthy volunteer" study

Sponsor Type

OTHER

Responsible Party

SPONSOR

Study Stopped

Rejuvenated RBC and VO2 Max in Healthy Subjects

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (1)

Study Arms (2)

Rejuvenated RBC Transfusion

Standard RBC Transfusion

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations

Rejuvenated RBC and VO2 Max in Healthy Subjects

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (1)

Study Arms (2)

Rejuvenated RBC Transfusion

Standard RBC Transfusion

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations