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Nitric Oxide During Bypass for Arterial Switch Operation

NCT03661385 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2024-04-18

No results posted yet for this study

Summary

This trial will test if adding nitric oxide (NO) gas to the cardiopulmonary bypass (CPB) circuit in infants undergoing an arterial switch operation (ASO) for Transposition of the Great Arteries (TGA) changes the incidence of major postoperative adverse events (AEs).

Major postoperative AEs include cardiac arrest, emergency chest opening, use of ECMO (machine that acts as an artificial heart and lung during surgery), and death.

Participants will be randomised to receive oxygen plus nitric oxide (intervention arm) or oxygen without nitric oxide (control arm) during CPB.

Conditions

  • Low Cardiac Output Syndrome
  • Transposition of Great Vessels

Interventions

DRUG

Nitric Oxide

Addition of nitric oxide 20ppm into bypass circuit

Sponsors & Collaborators

  • Murdoch Childrens Research Institute

    lead OTHER

Principal Investigators

  • Warwick Butt · MRCI

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
0 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-11
Primary Completion
2022-03-23
Completion
2023-04-23
FDA Drug
Yes

Countries

  • Australia
  • Canada
  • Indonesia
  • Malaysia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03661385 on ClinicalTrials.gov