SNO Therapy for Transfusion Reactions

Phase 1

Recruiting

Led By Mada Helou, MD

Research Sponsored by James Reynolds

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Healthy, non-pregnant adults with no pre-existing blood disorders or disease states that impact oxygen delivery

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre infusion and post infusion (every 3 to 6 hours, for 24 h)

Awards & highlights

Study Summary

This trial will test whether a SNO agent can improve oxygenation in people receiving transfusions of packed red blood cells.

Who is the study for?

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.Check my eligibility

What is being tested?

The trial is testing if an S-nitrosylating (SNO) agent can better tissue oxygenation when giving packed red blood cells during transfusions. Participants will receive either the SNO therapy or a normal saline solution as part of the study to compare outcomes.See study design

What are the potential side effects?

Potential side effects aren't specified but may include reactions related to vascular catheter placement, changes in blood pressure or heart rate due to the agents used, and possible allergic responses to inhalation products used during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a healthy adult, not pregnant, with no blood disorders affecting oxygen delivery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre infusion and post infusion (every 3 to 6 hours, for 24 hours)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre infusion and post infusion (every 3 to 6 hours, for 24 hours)

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre infusion and post infusion (every 3 to 6 hours, for 24 hours) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Increase in peripheral tissue oxygenation

Oxygenation Defined as change in arterial blood oxygenation

Oxygenation Defined as change in venous blood oxygenation CO2 ABG vs. VBG: VBG CO2 6mm Hg higher

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Blood transfusion with SNO agentActive Control2 Interventions

Autologous blood transfusion packed red blood cells (RBCs) while inhaling S-nitrosylating agent (SNO) A single intra venous blood transfusion of one unit of packed Red Blood Cells (RBCs) will be given over the standard transfusion flow rate of 5 ml/min under the direction of a physician or a licensed medical professional. Inhalation of SNO agent, 20-40 parts per million will occur during the transfusion.

Group II: Normal Saline with SNO agentPlacebo Group2 Interventions

Normal Saline Transfusion while inhaling S-nitrosylating agent (SNO) A single intra venous infusion of one unit of normal saline, will be given over the standard transfusion flow rate of 5 ml/min under the direction of a physician or a licensed medical professional. Inhalation of the SNO agent at 20-40 parts per million, will occur during the transfusion.

0 / 1Eligibility criteria met