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NCT01656993 · ClinicalTrials.gov registry record

Antiplatelet Activity of Aspirin in Infants After Aortopulmonary and Cavopulmonary Shunts

A clinical trial, sponsored by University of Utah.

Completed
Registry status
25
Enrollment target

NCT01656993: Completed study, sponsored by University of Utah.

NCT01656993 is a clinical trial that has completed, run by University of Utah. The registered enrollment target is 25 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01656993 has completed, sponsored by University of Utah.

COMPLETED
Registry status
25 participants
Enrollment target

Study Summary

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.

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2012-11
Est. Completion 2014-12
University of Utah

818 total trials

What the finished NCT01656993 record still lists

NCT01656993 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 25 participants, a relatively small participant target.

The record links to 0 conditions, and to 0 interventions.

NCT01656993 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01656993 about?

NCT01656993 is a clinical study titled "Antiplatelet Activity of Aspirin in Infants After Aortopulmonary and Cavopulmonary Shunts". 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...

What is the current status of trial NCT01656993?

This trial is currently completed. The enrollment target is 25 participants. The study started on 2012-11. Estimated completion is 2014-12.

Who is sponsoring clinical trial NCT01656993?

This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT01656993, the US trial registry maintained by the National Library of Medicine. NCT01656993 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.