Actively Recruiting

Phase 1
Age: 18Years - 35Years
All Genders
Healthy Volunteers
NCT03999229

S-Nitrosylation (SNO) Therapy During Autologous Blood Transfusion

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

35

Participants Needed

1

Research Sites

448 weeks

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

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).

CONDITIONS

Official 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 greater than 12 g/dl
  • Healthy, non-pregnant adults aged 18 to 35 with no blood disorders or diseases affecting oxygen delivery
  • Active blood and platelet donors are preferred participants familiar with blood withdrawal and reinfusion
Not Eligible

You will not qualify if you...

  • Pregnant, breastfeeding, or unwilling to avoid pregnancy during the study
  • Anatomic abnormalities increasing risks with vascular catheter placement
  • Chronic diseases requiring medication for heart, lungs, kidneys, liver, or acute/chronic conditions making participation unsuitable
  • 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, CNS agents, or nitrates
  • Long-term antihistamine use; occasional antihistamine use considered case-by-case
  • Blood pressure above 130/90 mm Hg; mild hypertension acceptable
  • Heart rate outside 50-100 beats per minute or pathological irregularity; lower pulse acceptable for endurance trainers
  • 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 impacting oxygen delivery
  • Reduced lung capacity
  • Difficulty with face mask use or inhalation for 2-3 hours due to claustrophobia, asthma, allergies, or sensitive skin

AI-Screening

AI-Powered Screening

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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

CONTACT

S

Sindhuja Senigarapu, MD

CONTACT

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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