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

Transfusion Related Complication

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

Inclusion Criteria4

Eligibility Criteria
Hemoglobin \> 12 g/dl
Healthy, non-pregnant adults with no pre-existing blood disorders or disease states that impact oxygen delivery.
a. 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 Criteria17

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.
Individuals with blood pressure parameters outside the normal range, i.e., higher than 130 mm Hg systolic and/or higher than 90 mm Hg diastolic; mild hypertension is acceptable by the Red Cross for blood donation.
Individuals with heart rates outside the range of 50 to 100 beats per minutes or with a pathologic irregularity.
a. Pulses lower than 50 may be acceptable if the study participant participates in endurance training. The study physician will be consulted for evaluation.
\. Individuals with an inherited or acquired blood coagulation disorder, congenital methemoglobinemia, or a familial hemoglobinopathy that impacts oxygen delivery (e.g. sickle cell).
\. Individuals with any illness that may increase the risks associated with the study.
\. Individuals who previously received blood products to treat an acute condition will be evaluated on a case by case basis.
\. Individuals who report an acute or chronic disease state that may impact oxygen delivery.
\. Individuals with evidence of diminished lung capacity.
\. Individuals who might have difficulty with the placement of a face mask (e.g. claustrophobia, uncontrolled asthma, severe allergies, sensitive skin) and/or the inhalation of a product for approximately 2-3 hours.