S-Nitrosylation (SNO) Therapy During Autologous Blood Transfusion

This study is testing if an S-nitrosylating (SNO) agent, given through inhalation, can improve how well your body's tissues get oxygen during a blood transfusion. Researchers are looking for healthy adults, aged 18 to 35, with a hemoglobin level above 12 g/dl and no existing blood disorders. You would receive a blood transfusion (Red Blood Cells) along with either the SNO agent or normal saline. The main goal is to see if the SNO agent helps your tissues use oxygen better. The study aims to enroll 35 participants, but its current recruitment status is unclear.

Study design
This interventional study plans to enroll 35 healthy participants. It compares the effects of SNO inhalation with normal saline during a blood transfusion.
What's involved
You would have continuous monitoring of tissue oxygenation for up to 24 hours, starting about 30 minutes before the transfusion. Blood samples would be taken every 3 to 6 hours for up to 24 hours.
Compensation
Not stated in the trial record.
Follow-up
Your tissue oxygenation and oxygen utilization will be monitored for up to 24 hours after the blood transfusion, until you are discharged.

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NCT03999229

S-Nitrosylation (SNO) Therapy During Autologous Blood Transfusion

Recruiting
PHASE1Ages 18–35InterventionalTreatment
James Reynolds
~35 participants
Updated 2025-12-02 on ClinicalTrials.gov
What's tested:SNONormal SalineRed Blood Cell

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Peripheral Tissue Oxygenation
Measured over Monitoring is continuous once the probes are placed on the skin. It will start approximately 30 minutes prior to blood transfsuion and continue overnight and then stopped next morning when subject is discharged. Total time is up to 24 hours.
+1 more outcome measured
Transfusion Related Complication
1 sites across 1 states
Ohio1
  • James D. Reynolds, PhD · PRINCIPAL_INVESTIGATOR · Case Western Reserve University
  • Mada Helou, MD · STUDY_DIRECTOR · University Hospitals Cleveland Medical Center

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  • Peripheral Tissue OxygenationMonitoring is continuous once the probes are placed on the skin. It will start approximately 30 minutes prior to blood transfsuion and continue overnight and then stopped next morning when subject is discharged. Total time is up to 24 hours.

    Measurement of small vessel blood flow and oxygenation status with near infrared spectroscopy (NIRS). NIRS can record the amount of oxygenated and de-oxygenated hemoglobin (the main protein in red blood cells) using different light frequencies shined through probes attached to the skin. The tissue oxygenation measurement is expressed as a percentage based on the ratio of oxygenated to de-oxygenated hemoglobin. It is continually-measured to see if it is changing in response to transfusion or administration of the study drug.

  • Oxygen UtilizationBlood samples are obtained every 3 to 6 hours before during and after blood transfsuion until subject is discharged Total time is up to 24 hour

    Determined by measuring arterial and venous blood oxygen levels - Blood Gas (BG) A BG is a test that measures the the levels of oxygen (O2) in the blood obtained from an artery or vein. The test is used to check the function of the patient's lungs and how well they are able to move oxygen around the body. The amount of oxygen is expressed as percent of the overall amount of hemoglobin. The difference in the amount of oxygen in arterial and venous blood is calculated as the measure of oxygen utilization and if it is changing in response to transfusion or administration of the study drug.