Effectiveness of aspirin in children undergoing heart surgery

Not Applicable

Recruiting

• Conditions: Congenital heart disease; Aspirin resistance; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12623001208695
• Lead Sponsor: Children's Health Queensland Hospital and Health Service

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-11-23
• Last Update Posted: 4 December 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

•Age 0-18 years of age
•Family/carer/patient able to provide informed consent.
•Children who require aspirin thromboprophylaxis after cardiac surgery such as;
•Systemic to pulmonary artery shunts
•Cavo-pulmonary shunt
•Fontan procedure
•Right ventricle to pulmonary artery conduit implantation
•Repairs involving large intra-cardiac baffles
•Valve repairs
•Any other patient receiving thromboprophylaxis with aspirin who does not meet the exclusion criteria

Exclusion Criteria

•Patients with documented allergic reaction to aspirin
•Patients in whom aspirin is contra-indicated due to past adverse reactions such as Reye’s syndrome or renal dysfunction
•Patients on long-term anticoagulation with other drugs in addition to aspirin e.g. warfarin, clopidogrel or other antiplatelet medications.
•Relative contraindication: Patients who had GI bleeds associated with aspirin in the past should be assessed carefully, but not excluded immediately, given that aspirin can cause gastritis in any patient if they are fasted, have a concurrent illness etc

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Inadequate response to aspirin as determined by LTA demonstrating >/=20% platelet aggregation stimulated by arachidonic acid [ After at least 3 days of adequate aspirin therapy - usually prior to hospital discharge, in rare circumstances at next outpatient visit]