Overview

This trial is active, not recruiting.

Condition congenital heart disease
Sponsor University of Colorado, Denver
Start date April 2014
End date June 2015
Trial size 75 participants
Trial identifier NCT02064179, 13-3167, UL1TR001082

Summary

The use of heparin and aspirin for their respective anticoagulation and antiplatelet effects is routine in intensive care units around the country and world in children who have undergone surgery for congenital heart disease (CHD) who are at risk for thrombosis after repair. Most common protocols recommend heparin infusions after surgery with transition to oral aspirin when oral intake begins. Patients at risk for thrombosis after congenital heart surgery requiring long-term antiplatelet therapy include those undergoing shunt placement for single-ventricle palliation or establishment of pulmonary blood flow, valve replacements, or coronary artery manipulation. Post-operative thrombosis after congenital heart surgery is rare, but thrombosis can result in death. The routine use of aspirin in these patients is intended to prevent the potentially catastrophic consequences of thrombosis. However, there is no routine clinical assessment of the platelet inhibitory effect of aspirin; nor have there been any prospective studies to assess the effectiveness of aspirin's antiplatelet effect in children after congenital heart surgery. No data exists to suggest that the first dose of aspirin transition from heparin infusion is either sufficient or insufficient in its antiplatelet effect.

In this study, the investigators will evaluate the effectiveness of the first aspirin dose in its antiplatelet effects after surgery for congenital heart disease. Degree of antiplatelet effect will be evaluated with thromboelastograph (TEG) and TEG-platelet mapping study analysis. Thromboelastography is a clinical laboratory method of assessing whole blood hemostasis and allows for assessment of clot formation, strength, and stability. TEG is most commonly used in patients at risk for bleeding or thrombosis and also to monitor antiplatelet therapies (such as aspirin).

The investigators hypothesize: the first dose of aspirin transitioned from heparin infusion after congenital heart surgery is sufficient in its antiplatelet effect as tested by TEG and TEG-platelet mapping studies. Confirmation of the antiplatelet effect of aspirin will help support the current practice of empiric aspirin therapy to prevent post-operative thrombosis in children after congenital heart surgery.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective

Primary Outcomes

Measure
Full platelet inhibition with aspirin 4-hours after surgery compared to prior to surgery
time frame: 4-hours after first aspirin dose

Secondary Outcomes

Measure
Full platelet inhibition at 24-hours if not achieved by 4-hours after aspirin administration
time frame: 24-hours after first aspirin dose (prior to second)

Eligibility Criteria

Male or female participants up to 18 years old.

Inclusion Criteria: - Age 0-18 - Undergoing surgery for congenital heart disease requiring oral antiplatelet therapy Exclusion Criteria: - Strict: personal or family history of bleeding/clotting disorder, patients requiring anticoagulation rather than antiplatelet therapy after surgery. - Relative: patients with significant post-operative bleeding precluding the use of anticoagulation and/or antiplatelet therapy within the first 48-72 hours (eg. clinical instability preventing the initiation of oral aspirin therapy), patients requiring additional fresh platelet transfusion after the initiation of post-operative heparin infusion.

Additional Information

Official title Assessment of Efficacy of the First Aspirin Dose in Children Undergoing Surgery for Congenital Heart Disease (CHD) Who Require Post-operative Antiplatelet Therapy; Evaluated by Thromboelastograph (TEG) Analysis and TEG-platelet Mapping
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by University of Colorado, Denver.