drugset / Trial / NCT03089047

Rejuvenated RBC and VO2 Max in Healthy Subjects

NCT03089047 ↗

Phase 4 Terminated 9 enrolled Duke University Zimmer Biomet · collab
RandomizedParallel-groupTriple-blindBasic science

Summary

To compare the physiologic benefits of rejuvenated RBCs (rejRBCs) to standards RBCs (PRBCs), we will emulate critical conditions by safely maximizing stress on the cardiovascular system, in an elective, feasible volunteer study. Maximal oxygen uptake (VO2max) will be measured in an anemic, post-donation, pre-transfusion state, and also after transfusing 14-day-old, autologous blood randomized to standard storage or standard storage with rejuvenation. We hypothesize that transfusion of standard PRBCs is less effective at increasing oxygen delivery (measured by VO2max) compared with transfusion of rejRBCs.

Timeline

Start
2017-09-29
Primary completion
2018-04-18
Completion
2018-04-18

Outcome

Outcome not reported

Stopped: “Reagent shortage”

Drugs

EvaluationDrugModalityDoseRoute
Subject Rejuvenated and washed autolgous RBCs Unknown 2 unknown —
Comparator Washed autolgous RBCs Unknown 2 unknown —

Indications

No indication recorded.