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:
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
  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:


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 April 16, 2014