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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 is a clinical trial that has completed, run by University of Utah. The registered enrollment target is 25 participants.
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
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2012-11 |
| Est. Completion | 2014-12 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01656993
The ClinicalTrials.gov registry entry for NCT01656993 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Utah, which has 818 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT01656993 reports 0 study locations.
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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