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Clinical Trials/ACTRN12618000089235
ACTRN12618000089235
Recruiting
未知

A randomised controlled trial of nitric oxide administration during cardiopulmonary bypass in neonates undergoing Arterial Switch Operation for repair of transposition of the great arteries to evaluate an effect on major adverse events (death, ECMO, cardiac arrest)

Christopher James0 sites800 target enrollmentJanuary 19, 2018

Overview

Phase
未知
Intervention
Not specified
Conditions
congenital heart disease
Sponsor
Christopher James
Enrollment
800
Status
Recruiting
Last Updated
4 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 19, 2018
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Christopher James

Eligibility Criteria

Inclusion Criteria

  • Neonate diagnosed with TGA requiring Arterial Switch Operation
  • Consent of parents/guardian.

Exclusion Criteria

  • Signs of persistently elevated pulmonary vascular resistance preoperatively requiring iNO or preoperative use of drugs involved in the NO pathway, such as nitro\-glycerine, sildenafil
  • Requirement for ECLS prior to surgery
  • Concurrent viral or bacterial acute or chronic infection, including pulmonary conditions such as pneumonia
  • Pre\-operative acute respiratory distress syndrome
  • Cardiac arrest prior to surgery
  • Prior surgical exposure to cardio\-pulmonary bypass

Outcomes

Primary Outcomes

Not specified

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