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Recruiting Phase 1 NCT03999229

S-Nitrosylation (SNO) Therapy During Autologous Blood Transfusion

Trial Parameters

Condition Transfusion Related Complication
Sponsor James Reynolds
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 35
Sex ALL
Min Age 18 Years
Max Age 35 Years
Start Date 2019-07-25
Completion 2028-02-29
Interventions
SNONormal SalineRed Blood Cell

Brief Summary

The Purpose of the study is to test the hypothesis that administration of an S-nitrosylating (SNO) agent can improve tissue oxygenation during transfusion of packed red blood cells (RBCs).

Eligibility Criteria

Eligibility Criteria Recruiting and studying of healthy human subjects with no pre-existing pathologic conditions from the local population. As a result the inclusion criteria is deliberately broad. Inclusion Criteria 1. Hemoglobin \> 12 g/dl 2. Healthy, non-pregnant adults with no pre-existing blood disorders or disease states that impact oxygen delivery. 2a. Active blood and platelet donors will be sought as study participants since these individuals are familiar with the routines for blood withdrawal and re-infusion. Exclusion Criteria The exclusion criteria is derived from the American Red Cross(ARC) Standard Operating Procedure (SOP) for autologous donation AND the parameters set out in the investigational new drug application (IND). 1. Individuals who are pregnant, breastfeeding, or are unwilling to avoid pregnancy during the study. 2. Individuals with an anatomic anomaly that would increase the risks associated with placement of the vascular catheters. 3. Individuals who report

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