RecruitingPhase 1

S-Nitrosylation (SNO) Therapy During Autologous Blood Transfusion

United States35 participantsStarted 2019-07-25

Plain-language 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).

Who can participate

Age range18 Years – 35 Years

SexALL

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Inclusion criteria

✓. Hemoglobin \> 12 g/dl
✓. Healthy, non-pregnant adults with no pre-existing blood disorders or disease states that impact oxygen delivery.

Exclusion criteria

✕. Individuals who are pregnant, breastfeeding, or are unwilling to avoid pregnancy during the study.
✕. Individuals with an anatomic anomaly that would increase the risks associated with placement of the vascular catheters.
✕. Individuals who report chronic diseases requiring medication of the heart, lungs, kidney, liver, etc or afflicted with any acute or chronic pathology that in the opinion of the screening physician makes them unsuitable for study.
✕. Individuals with a recent history of antibiotic therapy (check for underlying cause).
✕. Individuals unwilling to refrain from taking any phosphodiesterase 5 (PDE-5) inhibitor for at least 24 h prior to donation and/or autologous transfusion.
✕. Individuals taking a vitamin K antagonist (warfarin) or other anticoagulant (e.g. heparin, clopidogrel, enoxaparin or dalteparin).
✕. Individuals taking allopurinol, beta-adrenergic blockers, tricyclic antidepressants, meperidine (or related central nervous system (CNS) agents), or nitrates.
✕. Individuals on long-term antihistamine therapy 8a. The study physician will determine on a case by case basis the suitability for inclusion of individuals who control seasonal or acute allergies with occasional antihistamine use.

What they're measuring

Peripheral Tissue Oxygenation

Timeframe: Monitoring is continuous once the probes are placed on the skin. It will start approximately 30 minutes prior to blood transfsuion and continue overnight and then stopped next morning when subject is discharged. Total time is up to 24 hours.

Oxygen Utilization

Timeframe: Blood samples are obtained every 3 to 6 hours before during and after blood transfsuion until subject is discharged Total time is up to 24 hour

Trial details

NCT IDNCT03999229

SponsorJames Reynolds

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-02-29

Contact for this trial

James D Reynolds, PhD

216-334-9277 jxr343@case.edu

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