Phase 3
N=40
Nitric Oxide Administration During Pediatric Cardiopulmonary Bypass Surgery to Prevent Platelet Activation
Inflammation · Platelet Dysfunction
Bottom Line
View on ClinicalTrials.gov: NCT03455218 ↗Enrolled (actual)
40
Serious AEs
10.0%
Results posted
Aug 2020
Primary outcome: Primary: Change in Platelet Count — -221; -242 Count of platelets — p=0.55
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Nitric Oxide (Drug); Placebo (Drug); INOmax (Device)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Medical College of Wisconsin
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Platelet Count |
-221; -242 | 0.55 |
| PRIMARY 30 Day Mortality |
0; 0 | — |
| PRIMARY Hospital Length of Stay |
8; 16.5 | 0.30 |
| PRIMARY Methemoglobin Level Pre-CPB |
0.77; 0.99 | 0.11 |
| PRIMARY Methemoglobin Level-End of CPB |
1.56; 1.10 | 0.002 sig |
| PRIMARY Methemoglobin Level-ICU Admit |
1.3; 1.08 | 0.05 |
| SECONDARY Change in Platelet Response to TRAP as Measured by P-selectin Expression |
24; 30 | 0.27 |
| SECONDARY Change in Platelet Response to U46619 as Measured by P-selectin Expression |
51; 40 | 0.57 |
| SECONDARY Change in Platelet Response to CRP as Measured by P-selectin Expression |
23; 23 | — |
| SECONDARY Volume of Platelet Transfusion |
4; 9.8 | 0.48 |
| SECONDARY Volume of Packed Red Blood Cell Transfusion |
3.1; 0 | 0.96 |
| SECONDARY Transfusion Exposures |
2; 3 | 0.71 |
| SECONDARY Length of Mechanical Ventilation |
35.7; 28.2 | 0.97 |
| SECONDARY Vasoactive Infusion Score |
9; 9.5 | 0.53 |
| SECONDARY Number of Subjects Requiring Extracorporeal Membrane Oxygenation |
1; 1 | 1.0 |
| SECONDARY Hospital Cost |
137.7; 224.3 | 0.46 |
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.
Eligibility Criteria
Inclusion Criteria
- Infants less than one year of age
- Undergoing cardiac surgery with the use of cardiopulmonary bypass
Exclusion Criteria
- Prior surgery requiring CPB within the same hospitalization
- Pre-operative need for extracorporeal membrane oxygenation or mechanical circulatory support
- Known hypersensitivity to nitric oxide
- Known hemostatic or thrombotic disorder that results in an altered transfusion/anticoagulation protocol
Data sourced from ClinicalTrials.gov (NCT03455218). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.