Phase 1 Study of S-Nitrosylation Therapy to Improve Tissue Oxygenation During Autologous Blood Transfusion in Healthy Volunteer
James Reynolds
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).
Description
Transfusion is the most common therapeutic intervention employed to maintain and/or improve tissue and end-organ oxygen delivery. Despite the conceptual simplicity of this treatment recent studies indicate that RBC infusion often produces little clinical benefit and may actually harm the recipient by exacerbating rather than correcting anemia-induced tissue hypoxia. The main driver/regulator of tissue oxygenation is blood flow not blood oxygen content. In turn flow into the microvasculature is controlled by small molecules called S-nitrosothiols (SNOs), the most important of which is S-nitros…
Eligibility
- Age range
- 18–35 years
- Sex
- All
- Healthy volunteers
- Yes
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 Americ…
Interventions
- DrugSNO
S-nitrosylating agent (SNO) Inhalation
- DrugNormal Saline
Normal Saline transfusion
- DrugRed Blood Cell
Blood transfusion (RBCs)
Location
- University Hospitals Cleveland Medical CenterCleveland, Ohio