S-Nitrosylation (SNO) Therapy During Autologous Blood Transfusion

Launched by JAMES REYNOLDS · Jun 25, 2019

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called S-nitrosylation (SNO) therapy, which may help improve the delivery of oxygen to the body during blood transfusions. Researchers believe that using an SNO agent while giving packed red blood cells (the part of blood that carries oxygen) could enhance how well tissues receive oxygen. The trial is currently recruiting healthy adults aged between 18 and 75 who have a hemoglobin level of more than 12 g/dl and do not have any pre-existing medical conditions that affect oxygen delivery.

If you join this study, you can expect to undergo a blood donation and then receive a transfusion of your own blood after the SNO treatment. Participants should be in good overall health, not pregnant, and free from certain medical conditions, such as heart or lung diseases. The study will also exclude anyone currently taking specific medications or who may have issues with blood pressure or heart rate. This trial aims to determine if this new approach can safely and effectively improve oxygenation during blood transfusions, and your involvement could help advance medical knowledge in this area.

Gender

ALL

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.