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S-nitrosylating Agent

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

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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

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,836 Previous Clinical Trials

47,850,837 Total Patients Enrolled

Case Western Reserve UniversityOTHER

299 Previous Clinical Trials

260,077 Total Patients Enrolled

James ReynoldsLead Sponsor

2 Previous Clinical Trials

84 Total Patients Enrolled

Media Library

SNO (S-nitrosylating Agent) Clinical Trial Eligibility Overview. Trial Name: NCT03999229 — Phase 1

Transfusion Reactions Research Study Groups: Blood transfusion with SNO agent, Normal Saline with SNO agent

Transfusion Reactions Clinical Trial 2023: SNO Highlights & Side Effects. Trial Name: NCT03999229 — Phase 1

SNO (S-nitrosylating Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03999229 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the recruitment period for this trial begun?

"This clinical trial, which was created on July 25th 2019 and has been recently updated on August 18th 2022, is currently recruiting participants as noted in the information hosted on clinicaltrials.gov."

Answered by AI

What is the current capacity of participants for this clinical experiment?

"Affirmative, the information hosted on clinicaltrials.gov confirms that recruitment is ongoing for this medical trial which first appeared online on July 25th 2019. Its most recent update was posted on August 18th 2022 and it seeks to enlist 20 individuals from a single site."

Answered by AI

Does my profile fit the requirements to join this research initiative?

"This trial is currently enrolling 20 participants, aged 18-35 years old, suffering from transfusion related complications. In order to be considered eligible for this study, the following criteria must be met: active blood and platelet donors as they are experienced with procedures of withdrawal/infusion; healthy non-pregnant adults free of pathologic conditions that affect oxygen delivery; recruiting and studying healthy human subjects in the local population. Thus, inclusionary guidelines have been kept wide-ranging."

Answered by AI

Is the experimental research accepting participants of advanced age?

"This clinical trial is seeking participants that are within the 18 to 35-year age bracket."

Answered by AI

Has the FDA authorized transfusions of SNO agents for blood donation?

"The safety of a blood transfusion with SNO agent is rated at 1 on the scale since it has not undergone extensive testing and there is limited evidence to suggest its efficacy."

Answered by AI

Recent research and studies

Proceedings of the National Academy of SciencesJournal

A Nitric Oxide Processing Defect of Red Blood Cells Created by Hypoxia: Deficiency of S-nitrosohemoglobin in Pulmonary Hypertension

McMahon, Timothy J., Gregory S. Ahearn, Martin P. Moya, Andrew J. Gow, Yuh-Chin T. Huang, Benjamin P. Luchsinger, Raphael Nudelman, et al.. 2005. “A Nitric Oxide Processing Defect of Red Blood Cells Created by Hypoxia: Deficiency of S-nitrosohemoglobin in Pulmonary Hypertension”. Proceedings of the National Academy of Sciences. Proceedings of the National Academy of Sciences. doi:10.1073/pnas.0506957102.

The LancetJournal

Defective Gas-transport Function of Stored Red Blood-cells

Valtis, D.J., and A.C. Kennedy. 1954. “Defective Gas-transport Function of Stored Red Blood-cells”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(54)90978-2.

Vox SanguinisJournal

The Physiologic Effect of Transfusing Preserved Red Cells with Low 2,3-diphosphoglycerate and High Affinity for Oxygen

Valeri, C. R., and F. B. Collins. 1971. “The Physiologic Effect of Transfusing Preserved Red Cells with Low 2,3-diphosphoglycerate and High Affinity for Oxygen”. Vox Sanguinis. Wiley. doi:10.1111/j.1423-0410.1971.tb01807.x.

The Journal of Trauma: Injury, Infection, and Critical CareJournal