RecruitingPhase 1NCT03999229

S-Nitrosylation (SNO) Therapy During Autologous Blood Transfusion

Phase 1 Study of S-Nitrosylation Therapy to Improve Tissue Oxygenation During Autologous Blood Transfusion in Healthy Volunteer


Sponsor

James Reynolds

Enrollment

35 participants

Start Date

Jul 25, 2019

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 35 Years

Plain Language Summary

Simplified for easier understanding

This study investigates a new way to treat blood before it is re-infused back into a donor — a process called autologous blood transfusion. Blood stored outside the body loses some of its ability to deliver oxygen efficiently. The researchers believe that adding a specific chemical modification (S-nitrosylation) to the hemoglobin in stored blood can restore its oxygen-delivery function. This could be important for patients who donate their own blood before surgery and have it returned. Healthy volunteers will donate blood, which will be modified using the study compound and then re-transfused back into the same person. Researchers will closely monitor how the treated blood performs in delivering oxygen compared to unmodified stored blood. You may be eligible if: - You are a healthy adult aged 18–35 - Your hemoglobin is above 12 g/dL - You have no chronic diseases or pre-existing blood disorders - You are not pregnant or breastfeeding You may NOT be eligible if: - You are pregnant, breastfeeding, or unwilling to avoid pregnancy during the study - You have chronic heart, lung, kidney, or liver disease - You are taking anticoagulants (warfarin, heparin, etc.), certain antidepressants, beta-blockers, or nitrates - You have high blood pressure (above 130/90 mmHg) or abnormal heart rate - You have a blood clotting disorder or hemoglobin condition such as sickle cell - You are on long-term antihistamine therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSNO

S-nitrosylating agent (SNO) Inhalation

DRUGNormal Saline

Normal Saline transfusion

DRUGRed Blood Cell

Blood transfusion (RBCs)


Locations(1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

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NCT03999229


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