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New treatment option for Transfusion Related Complication
Official title S-Nitrosylation (SNO) Therapy During Autologous Blood Transfusion
ClinicalTrials.gov ID: NCT03999229
What this study is testing
What is SNO?
SNO is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for transfusion related complication.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 35. Healthy volunteers may be eligible.
You may be able to join if
- Eligibility Criteria Recruiting and studying of healthy human people with no pre-existing pathologic conditions from the local population. As a...
- Hemoglobin \> 12 g/dl
- Healthy, non-pregnant adults with no pre-existing blood disorders or disease states that impact oxygen delivery. 2a. Active blood and platelet donors...
You likely can't join if
- The exclusion criteria is derived from the American Red Cross(ARC) Standard Operating Procedure (SOP) for autologous donation AND the parameters set...
- 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...
- Individuals with a recent history of antibiotic therapy (check for underlying cause).
- Individuals unwilling to refrain from taking any phosphodiesterase 5 (PDE-5) inhibitor for at least 24 h prior to donation and/or autologous...
See the full eligibility criteria
- Eligibility Criteria Recruiting and studying of healthy human people with no pre-existing pathologic conditions from the local population. As a result the is deliberately broad.
- Hemoglobin \> 12 g/dl
- Healthy, non-pregnant adults with no pre-existing blood disorders or disease states that impact oxygen delivery. 2a. Active blood and platelet donors will be sought as study participants since these individuals are...
- The exclusion criteria is derived from the American Red Cross(ARC) Standard Operating Procedure (SOP) for autologous donation AND the parameters set out in the investigational new drug application (IND).
- 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...
- Individuals with a recent history of antibiotic therapy (check for underlying cause).
- Individuals unwilling to refrain from taking any phosphodiesterase 5 (PDE-5) inhibitor for at least 24 h prior to donation and/or autologous transfusion.
- Individuals taking a vitamin K antagonist (warfarin) or other anticoagulant (e.g. heparin, clopidogrel, enoxaparin or dalteparin).
- Individuals taking allopurinol, beta-adrenergic blockers, tricyclic antidepressants, meperidine (or related central nervous system (CNS) agents), or nitrates.
- Individuals on long-term antihistamine therapy 8a. The study physician will determine on a case by case basis the suitability for inclusion of individuals who control seasonal or acute allergies with occasional...
- Individuals with blood pressure parameters outside the normal range, i.e., higher than 130 mm Hg systolic and/or higher than 90 mm Hg diastolic; mild hypertension is acceptable by the Red Cross for blood donation.
- Individuals with heart rates outside the range of 50 to 100 beats per minutes or with a pathologic irregularity. 10a. Pulses lower than 50 may be acceptable if the study participant participates in endurance training...
The study team makes the final eligibility decision.
Where it's taking place
- Cleveland, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 35 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cleveland, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.