NCT03999229 S-Nitrosylation (SNO) Therapy During Autologous Blood Transfusion
| NCT ID | NCT03999229 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | James Reynolds |
| Condition | Transfusion Related Complication |
| Study Type | INTERVENTIONAL |
| Enrollment | 35 participants |
| Start Date | 2019-07-25 |
| Primary Completion | 2028-02-29 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 35 participants in total. It began in 2019-07-25 with a primary completion date of 2028-02-29.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Eligibility Criteria Recruiting and studying of healthy human subjects with no pre-existing pathologic conditions from the local population. As a result the inclusion criteria is deliberately broad. Inclusion Criteria 1. Hemoglobin \> 12 g/dl 2. Healthy, non-pregnant adults with no pre-existing blood disorders or disease states that impact oxygen delivery. 2a. 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 Criteria The exclusion criteria is derived from the American Red Cross(ARC) Standard Operating Procedure (SOP) for autologous donation AND the parameters set out in the investigational new drug application (IND). 1. Individuals who are pregnant, breastfeeding, or are unwilling to avoid pregnancy during the study. 2. Individuals with an anatomic anomaly that would increase the risks associated with placement of the vascular catheters. 3. 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. 4. Individuals with a recent history of antibiotic therapy (check for underlying cause). 5. Individuals unwilling to refrain from taking any phosphodiesterase 5 (PDE-5) inhibitor for at least 24 h prior to donation and/or autologous transfusion. 6. Individuals taking a vitamin K antagonist (warfarin) or other anticoagulant (e.g. heparin, clopidogrel, enoxaparin or dalteparin). 7. Individuals taking allopurinol, beta-adrenergic blockers, tricyclic antidepressants, meperidine (or related central nervous system (CNS) agents), or nitrates. 8. 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. 9. 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. 10. Individuals with heart rates outside the range of 50 to 100 beats per minutes or with a pathologic irregularity. 10a. Pulses lower than 50 may be acceptable if the study participant participates in endurance training. The study physician will be consulted for evaluation. 11\. Individuals with an inherited or acquired blood coagulation disorder, congenital methemoglobinemia, or a familial hemoglobinopathy that impacts oxygen delivery (e.g. sickle cell). 12\. Individuals with any illness that may increase the risks associated with the study. 13\. Individuals who previously received blood products to treat an acute condition will be evaluated on a case by case basis. 14\. Individuals who report an acute or chronic disease state that may impact oxygen delivery. 15\. Individuals with evidence of diminished lung capacity. 16\. 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.
Contact & Investigator
James D. Reynolds, PhD
PRINCIPAL INVESTIGATOR
Case Western Reserve University
Frequently Asked Questions
Who can join the NCT03999229 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 35 Years, studying Transfusion Related Complication. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03999229 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT03999229 currently recruiting?
Yes, NCT03999229 is actively recruiting participants. Contact the research team at jxr343@case.edu for enrollment information.
Where is the NCT03999229 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT03999229 clinical trial?
NCT03999229 is sponsored by James Reynolds. The principal investigator is James D. Reynolds, PhD at Case Western Reserve University. The trial plans to enroll 35 participants.