CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 40 enrolled
Drug / intervention
Nitric Oxide +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03455218
NCT03455218Phase 3Completed

Nitric Oxide Administration During Pediatric Cardiopulmonary Bypass Surgery to Prevent Platelet activation-a Single Center Pilot Study

Medical College of Wisconsin·interventional·Posted Mar 6, 2018·Updated Aug 13, 2020

In Brief

A Phase 3 clinical trial evaluating Nitric Oxide, Placebo, and 1 other intervention for Inflammation and Platelet Dysfunction. Completed, enrolled 40 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedMar 6, 2018
Enrollment StartApr 25, 2018
Primary CompletionApr 20, 2019
Study CompletionMay 5, 2019
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 8.3 years ago

Interventions

Nitric Oxidedrug

20 ppm of Nitric Oxide gas delivered to the oxygenator for the duration of cardiopulmonary bypass

Placebodrug

INOmax device connected to oxygenator, but no gas is delivered

INOmaxdevice

All patients will have the INOmax device connected to the oxygenator