Actively Recruiting

Phase 1
Age: 18Years - 35Years
All Genders
Healthy Volunteers
ID03999229

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

Led by James Reynolds · Updated on 2025-12-02

35

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

J

James Reynolds

Lead Sponsor

C

Case Western Reserve University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying a new approach to improve tissue oxygenation during blood transfusions by adding an S-nitrosylating (SNO) agent. The study focuses on healthy adults and addresses the concern that stored red blood cells may lose their ability to help deliver oxygen properly, potentially causing more harm than benefit during transfusions. This Phase 1 study explores if the SNO agent can restore this oxygen delivery function. Participants will receive either an autologous transfusion of one unit of packed red blood cells while inhaling the SNO agent at 20-40 parts per million, or a transfusion of normal saline with SNO inhalation at 40 parts per million. The blood or saline infusion is given intravenously at a flow rate of 5 ml per minute under medical supervision. The study compares the effects of these treatments on tissue oxygenation. During the study, participants will be continuously monitored for peripheral tissue oxygenation starting about 30 minutes before transfusion and continuing overnight, up to 24 hours. Blood samples will be collected every 3 to 6 hours before, during, and after transfusion to assess oxygen use, kidney and liver function, and immune status. Participants will be observed overnight and discharged the next morning, with all measurements focused on safety and treatment effects.

CONDITIONS

Brief Title

S-Nitrosylation (SNO) Therapy During Autologous Blood Transfusion

Who Can Participate

Age: 18Years - 35Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Hemoglobin > 12 g/dl
  • Healthy, non-pregnant adults with no pre-existing blood disorders or diseases affecting oxygen delivery
  • Active blood and platelet donors familiar with blood withdrawal and reinfusion routines
Not Eligible

You will not qualify if you...

  • Pregnant, breastfeeding, or unwilling to avoid pregnancy during the study
  • Anatomic anomalies increasing risks with vascular catheter placement
  • Chronic diseases requiring medication for heart, lungs, kidney, liver, or other acute or chronic pathology deemed unsuitable by the screening physician
  • Recent antibiotic therapy
  • Use of phosphodiesterase 5 inhibitors within 24 hours before donation or transfusion
  • Use of blood thinners such as warfarin, heparin, clopidogrel, enoxaparin, or dalteparin
  • Use of allopurinol, beta-blockers, tricyclic antidepressants, meperidine or related CNS agents, or nitrates
  • Long-term antihistamine therapy (with some exceptions for occasional use)
  • Blood pressure higher than 130/90 mm Hg (mild hypertension acceptable)
  • Heart rate outside 50 to 100 beats per minute or pathologic irregularity
  • Inherited or acquired blood coagulation disorders, congenital methemoglobinemia, or familial hemoglobinopathies impacting oxygen delivery
  • Any illness increasing study risks
  • Previous blood product treatment for acute conditions (evaluated case by case)
  • Acute or chronic diseases affecting oxygen delivery
  • Diminished lung capacity
  • Difficulty with face mask placement or inhalation of study product for 2-3 hours due to claustrophobia, asthma, allergies, or sensitive skin

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single day

Participants receive a single intravenous transfusion of either autologous packed red blood cells or normal saline while inhaling an S-nitrosylating agent.

1 infusion visit (in-person)

Follow-up

Duration - Up to 24 hours post-transfusion

Participants are monitored continuously for up to 24 hours after transfusion, including tissue oxygenation and blood sample collections every 3 to 6 hours.

Continuous monitoring overnight and blood draws every 3 to 6 hours until discharge

Trial Site Locations

Total: 1 location

1

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States, 44106

Actively Recruiting

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Research Team

J

James D Reynolds, PhD

S

Sindhuja Senigarapu, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

A nitric oxide processing defect of red blood cells created by hypoxia: deficiency of S-nitrosohemoglobin in pulmonary hypertension.

Timothy J McMahon, Gregory S Ahearn, Martin P Moya...

https://pubmed.ncbi.nlm.nih.gov/16203976