SNO Therapy for Transfusion Reactions
Trial Summary
What is the purpose of this trial?
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).
Will I have to stop taking my current medications?
The trial requires participants to stop taking certain medications, including phosphodiesterase 5 inhibitors, vitamin K antagonists, anticoagulants, allopurinol, beta-adrenergic blockers, tricyclic antidepressants, meperidine, nitrates, and long-term antihistamines. If you use antihistamines occasionally for allergies, the study physician will decide if you can participate.
What data supports the effectiveness of SNO Therapy for transfusion reactions?
Research on S-nitrosylation (SNO) shows that it can have protective effects in the body, such as preventing damage to heart tissue. Additionally, S-nitrosothiols, which are related to SNO, have been effective in treating various conditions like asthma and cystic fibrosis, suggesting potential benefits for other medical uses.12345
Is SNO Therapy generally safe for humans?
Research on S-nitrosothiols (SNOs) suggests they are promising for therapeutic use in various conditions, and early results indicate they can be safe and effective, particularly in cancer and neonatal pulmonary hypertension. However, more research is needed to fully understand their safety profile in humans.13456
How does SNO Therapy differ from other treatments for transfusion reactions?
SNO Therapy is unique because it uses S-nitrosylated human serum albumin (SNO-HSA) to deliver nitric oxide (NO) in a controlled manner, potentially reducing side effects and improving efficacy compared to traditional NO donors. This approach may offer a novel way to manage transfusion reactions by leveraging the cytoprotective and anti-inflammatory properties of NO.12357
Research Team
Batuhan Degis, MD
Principal Investigator
Case Western Reserve University
Mada Helou, MD
Principal Investigator
University Hospitals Cleveland Medical Center
Eligibility Criteria
Healthy, non-pregnant adults with normal hemoglobin levels (>12 g/dl) and no blood disorders or diseases affecting oxygen delivery can join. Ideal candidates are active blood/platelet donors familiar with transfusion processes. Exclusions include pregnant/breastfeeding individuals, those on certain medications like anticoagulants or antidepressants, people with irregular heart rates or lung capacity issues, and anyone with a condition that could increase study risks.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single intravenous blood transfusion of one unit of packed Red Blood Cells (RBCs) while inhaling an S-nitrosylating agent (SNO)
Monitoring
Continuous monitoring of peripheral tissue oxygenation and other physiological parameters using near infrared spectroscopy (NIRS) and blood gas analysis
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of immune status, kidney function, and liver function
Treatment Details
Interventions
- Normal Saline
- Red Blood Cell
- SNO
Find a Clinic Near You
Who Is Running the Clinical Trial?
James Reynolds
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Case Western Reserve University
Collaborator