Antiplatelet Activity of Aspirin in Infants After Aortopulmonary and Cavopulmonary Shunts

Completed

Conditions studied: Congenital Heart Disease

In brief

Background: Blood clots cause poor outcomes, including death, in babies with heart defects that require a surgical connection ("shunt") to provide blood flow to their lungs. Aspirin (ASA) blocks the part of the blood that helps clots form (platelets). Aspirin is used in babies with shunts to prevent blood clots. The dose of aspirin given to babies is based on adult research. Because babies are different from adults, the investigators do not know if the dose is enough to block platelets, or if it is too much and may cause bleeding. The investigators can test the platelets using a blood test called Thromboelastography with Platelet Mapping (TEG-PM). This test needs a small amount of blood so it can be used in babies. Hypothesis and Specific Aims: The investigators suspect the aspirin doses typically given babies are not enough to block platelets and prevent blood clots in their shunts. The investigators want to determine the percentage of babies whose platelets are not blocked enough (\< 70% inhibition), by using TEG-PM. The investigators also want to determine how often bleeding or clots occur in babies receiving aspirin.

Key facts

Study ID

NCT01656993

Run by

University of Utah

People needed

25

Starts

2012-11-01

Expected to finish

2014-12-01

Last updated by the study team

2017-05-05

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Undergoing cardiac surgery for a shunt and planned treatment with aspirin
• Age 2.0 days to 12 months
• Consent of parent or guardian

You may not qualify if…

• Known or suspected congenital or acquired coagulation disorders (such as hemophilia, von Willebrands disease, Glansmans thrombasthenia).
• History of aspirin use within 7 days of surgery.
• Platelet count < 50K prior to surgery.
• Weight < 2.5 kg.
• Prematurity defined as gestational age < 37 weeks.

Where it is running

• Primary Children's Medical Center — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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