S-Nitrosylation (SNO) Therapy During Autologous Blood Transfusion

Conditions

• Transfusion Related Complication

Eligibility Criteria

Sex

ALL

Age

18 Years - 35 Years

Healthy Volunteers

Accepted

Interventions

• SNO — DRUG
  S-nitrosylating agent (SNO) Inhalation
• Normal Saline — DRUG
  Normal Saline transfusion
• Red Blood Cell — DRUG
  Blood transfusion (RBCs)

Study Details

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).

Key Dates

Start date

Jul 25, 2019

Status verified

Nov 2025

Primary completion

Feb 29, 2028

Completion

Feb 29, 2028

Study Design

Enrollment

35 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Blood transfusion with SNO agent
  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.
• Placebo Comparator: Normal Saline with SNO agent
  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 40 parts per million, will occur during the transfusion.

Primary Outcome Measure

Peripheral Tissue Oxygenation [ Time Frame: 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. ]

Central Contacts

• James D Reynolds, PhD
  216-334-9277
  [email protected]
• Sindhuja Senigarapu, MD
  216-334-9277
  [email protected]

Locations (1)

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