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NCT03455218 · ClinicalTrials.gov registry record · Phase 2
Nitric Oxide Administration During Pediatric Cardiopulmonary Bypass Surgery to Prevent Platelet Activation
A Phase 2 study, sponsored by Medical College of Wisconsin.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
NCT03455218 is a Phase 2 study that has completed, run by Medical College of Wisconsin. The registered enrollment target is 40 participants.
The verdict
NCT03455218, a Phase 2 study, has completed, sponsored by Medical College of Wisconsin.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
Study Summary
Open heart surgery requires the use of a cardiopulmonary bypass (CPB) circuit. As blood flows across the artificial surfaces of the CPB circuit, platelets are activated and consumed. This activation results in a profound inflammatory reaction and need for transfusion. This reaction is intensified in younger, smaller patients undergoing longer, more complex open heart surgery. Nitric oxide is naturally released by vascular endothelial surfaces and acts as a signaling molecule which prevents platelet activation. The investigators hypothesize that the addition of the nitric oxide to the sweep gas of the oxygenator during cardiopulmonary bypass surgery will replace this natural endothelial function and thus prevent platelet activation and consumption. The investigators plan to test this hypothesis with a pilot double blinded, randomized trial of 40 patients less than a year of age undergoing cardiac surgery requiring CPB.
Interventions
- DRUG Placebo
- DRUG Nitric Oxide
- DEVICE INOmax
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2018-04-25 |
| Est. Completion | 2019-05-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03455218
The ClinicalTrials.gov registry entry for NCT03455218 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical College of Wisconsin, which has 447 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03455218 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03455218 about?
NCT03455218 is a clinical study titled "Nitric Oxide Administration During Pediatric Cardiopulmonary Bypass Surgery to Prevent Platelet Activation". Open heart surgery requires the use of a cardiopulmonary bypass (CPB) circuit. As blood flows across the artificial surfaces of the CPB circuit, platelets are activated and consumed. This activation results in a profound inflammatory reaction and need for transfusion. This reaction is intensified in...
What is the current status of trial NCT03455218?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2018-04-25. Estimated completion is 2019-05-05.
What interventions are being tested in trial NCT03455218?
The interventions under investigation include: Placebo (DRUG), Nitric Oxide (DRUG), INOmax (DEVICE).
Who is sponsoring clinical trial NCT03455218?
This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.
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