Health TrialsbyHealthPanel

S-Nitrosylation (SNO) Therapy During Autologous Blood Transfusion

ConditionTransfusion Related Complication
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-35
SponsorJames Reynolds

About 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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Hemoglobin > 12 g/dl

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

Disqualifiers

Individuals who are pregnant, breastfeeding, or are unwilling to avoid pregnancy during the study.

Individuals with an anatomic anomaly that would increase the risks associated with placement of the vascular catheters.

Individuals who report chronic diseases requiring medication of the heart, lungs, kidney, liver, etc or afflicted with any acute or chronic pathology that in the opinion of the screening physician makes them unsuitable for study.

Individuals with a recent history of antibiotic therapy (check for underlying cause).

Trial design

Design model

Parallel

Treatments tested in this trial

  • SNO

    Drug

    S-nitrosylating agent (SNO) Inhalation

  • Normal Saline

    Drug

    Normal Saline transfusion

  • Red Blood Cell

    Drug

    Blood transfusion (RBCs)

Treatment groups

35 Participants
are divided into 2 treatment groups
Group A: Blood transfusion with SNO agentActive comparator 2 interventions
Group B: Normal Saline with SNO agentPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Peripheral Tissue Oxygenation

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.

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.
2

Oxygen Utilization

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.

Time frame
Blood 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

Secondary outcomes

1

Kidney Function Test

Blood samples will be assayed for markers of kidney function: creatinine - milligram per deciliter albumin - grams per deciliter blood urea nitrogen - milligram per deciliter This 3 blood markers are incorporated into a formula to calculate glomerular filtration rate or GFR. This is a measure of how well your kidneys are filtering your blood and if it is changing in response to transfusion or administration of the study drug.

Time frame
Blood 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
2

Liver Function Test

Blood samples will be assayed for markers of liver function: alanine transaminase or ALT - units per liter aspartate aminotransferase or AST - units per liter The individual values are determined then the AST/ALT ratio is calculated to provide further information on liver status and if it is changing in response to transfusion or administration of the study drug.

Time frame
Blood 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
3

Assessment of Immune Status

The number of white blood cells is counted in each blood sample. White blood cells (also called leukocytes) are an important measure of how the immune system is working and if it is changing in response to transfusion or administration of the study drug. leukocytes - reported as cell counts

Time frame
Blood 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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

James Reynolds

Lead sponsor

Case Western Reserve University

Sponsor institution

Case Western Reserve University

Collaborator

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov
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