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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: Completed Phase 2 study, sponsored by Medical College of Wisconsin.
NCT03455218 is a Phase 2 study that has completed, run by Medical College of Wisconsin. The registered enrollment target is 40 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Change in platelet count from baseline to conclusion of cardiopulmonary bypass = (Platelet count at end of CPB) - (Platelet count prior to start of 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 |
What the finished NCT03455218 record still lists
NCT03455218 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03455218 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03455218's enrollment target sits among peer trials
40 1362nd of 2000 higher than 542 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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