Antiplatelet Activity of Aspirin in Infants After Aortopulmonary and Cavopulmonary Shunts
This study is not yet open for participant recruitment.
Verified August 2012 by University of Utah
Sponsor:
University of Utah
Information provided by (Responsible Party):
Dongngan Truong, University of Utah
ClinicalTrials.gov Identifier:
NCT01656993
First received: July 26, 2012
Last updated: August 29, 2012
Last verified: August 2012
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Purpose
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.
| Condition |
|---|
|
Congenital Heart Disease |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Antiplatelet Activity of Aspirin in Infants After Aortopulmonary and Cavopulmonary Shunts |
Resource links provided by NLM:
MedlinePlus related topics:
Heart Diseases
Drug Information available for:
Aspirin
U.S. FDA Resources
Further study details as provided by University of Utah:
Primary Outcome Measures:
- The percentage of arachidonic acid inhibition of platelets, as measured by TEG-PM after the initiation of ASA. [ Time Frame: TEG-PM will be measured after the third dose of ASA is given postoperatively. (up to 6 months after surgery) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- The percentage of arachidonic acid inhibition of platelets, as measured by TEG-PM at the first postoperative cardiology clinic visit. [ Time Frame: The percentage of arachidonic acid inhibition will be measured at the first post-operative cardiology clinic vist (typically 2-4 weeks after hospital discharge) ] [ Designated as safety issue: No ]
- The percentage of arachidonic acid inhibition of platelets, as measured by TEG-PM 3-6 months after surgery. [ Time Frame: TEG-PM will be measured 3-6 months postoperatively to determine the percentage of arachidonic acid inhibition. ] [ Designated as safety issue: No ]
- The number of bleeding and thrombotic events while patients are on ASA. [ Time Frame: Patients will be monitored for bleeding and thrombotic events while on ASA for the duration of this study, thus for up to 1.5 years. ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 45 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
ASA activity
Participants (age 2.0 days to 12 months) undergoing cardiac surgery for a shunt and planned treatment with aspirin
|
Show Detailed Description Eligibility| Ages Eligible for Study: | up to 12 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Infants undergoing cardiac surgery involving aortopulmonary and/or cavopulmonary shunts with planned aspirin treatment
Criteria
Inclusion Criteria:
- Undergoing cardiac surgery for a shunt and planned treatment with aspirin
- Age 2.0 days to 12 months
- Consent of parent or guardian
Exclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01656993
Contacts
| Contact: Dongngan Truong, MD | 801.662.5497 | dongngan.truong@imail.org |
Locations
| United States, Utah | |
| Primary Children's Medical Center | Not yet recruiting |
| Salt Lake City, Utah, United States, 84113 | |
| Contact: Dongngan Truong, MD 801-662-5497 dongngan.truong@imail.org | |
| Contact: LuAnn Minich, MD 801.662.5464 luann.minich@imail.org | |
| Principal Investigator: Dongngan Truong, MD | |
| Sub-Investigator: LuAnn Minich, MD | |
| Sub-Investigator: Gordon Mack, MD | |
| Sub-Investigator: Madolin Witte, MD | |
Sponsors and Collaborators
University of Utah
Investigators
| Principal Investigator: | Dongngan Truong, MD | University of Utah / Primary Children's Medical Center |
More Information
Publications:
Monagle P, Chan AK, Goldenberg NA, Ichord RN, Journeycake JM, Nowak-Gottl U, Vesely SK. Antithrombotic Therapy in Neonates and Children: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141:e737S-801S
| Responsible Party: | Dongngan Truong, Pediatric Cardiology Fellow, University of Utah |
| ClinicalTrials.gov Identifier: | NCT01656993 History of Changes |
| Other Study ID Numbers: | 55107 |
| Study First Received: | July 26, 2012 |
| Last Updated: | August 29, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Utah:
|
Aspirin ASA aortopulmonary shunt cavopulmonary shunt |
shunt TEG Antiplatelet |
Additional relevant MeSH terms:
|
Heart Diseases Heart Defects, Congenital Cardiovascular Diseases Cardiovascular Abnormalities Congenital Abnormalities Aspirin Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions |
Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Hematologic Agents Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 16, 2013