Antiplatelet Activity of Aspirin in Infants After Aortopulmonary and Cavopulmonary Shunts

NCT01656993 | Completed DMC

• 1 other identifier: 55107
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Congenital Heart Disease

Keywords

Aspirin; ASA; aortopulmonary shunt; cavopulmonary shunt; shunt; TEG; Antiplatelet

Outcome Measures

Primary Outcomes (1)

• The percentage of arachidonic acid inhibition of platelets, as measured by TEG-PM after the initiation of ASA.

  TEG-PM will be measured after the third dose of ASA is given postoperatively. (up to 6 months after surgery)

Secondary Outcomes (3)

• The percentage of arachidonic acid inhibition of platelets, as measured by TEG-PM at the first postoperative cardiology clinic visit.

  The percentage of arachidonic acid inhibition will be measured at the first post-operative cardiology clinic vist (typically 2-4 weeks after hospital discharge)

• The percentage of arachidonic acid inhibition of platelets, as measured by TEG-PM 3-6 months after surgery.

  TEG-PM will be measured 3-6 months postoperatively to determine the percentage of arachidonic acid inhibition.

• The number of bleeding and thrombotic events while patients are on ASA.

  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.

Study Arms (1)

ASA activity

Participants (age 2.0 days to 12 months) undergoing cardiac surgery for a shunt and planned treatment with aspirin

Eligibility Criteria

• Age: 2 Days - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Infants undergoing cardiac surgery involving aortopulmonary and/or cavopulmonary shunts with planned aspirin treatment

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.

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

Primary Children's Medical Center

Salt Lake City, Utah, 84113, United States

Location

Related Publications (7)

• Li JS, Yow E, Berezny KY, Rhodes JF, Bokesch PM, Charpie JR, Forbus GA, Mahony L, Boshkov L, Lambert V, Bonnet D, Michel-Behnke I, Graham TP, Takahashi M, Jaggers J, Califf RM, Rakhit A, Fontecave S, Sanders SP. Clinical outcomes of palliative surgery including a systemic-to-pulmonary artery shunt in infants with cyanotic congenital heart disease: does aspirin make a difference? Circulation. 2007 Jul 17;116(3):293-7. doi: 10.1161/CIRCULATIONAHA.106.652172. Epub 2007 Jun 25.

  PMID: 17592082 BACKGROUND

• Monagle P, Chan AKC, 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 Feb;141(2 Suppl):e737S-e801S. doi: 10.1378/chest.11-2308.

  PMID: 22315277 BACKGROUND

• Fenton KN, Siewers RD, Rebovich B, Pigula FA. Interim mortality in infants with systemic-to-pulmonary artery shunts. Ann Thorac Surg. 2003 Jul;76(1):152-6; discussion 156-7. doi: 10.1016/s0003-4975(03)00168-1.

  PMID: 12842531 BACKGROUND

• Frelinger AL, Li Y, Linden MD, Tarnow I, Barnard MR, Fox ML, Michelson AD. Aspirin 'resistance': role of pre-existent platelet reactivity and correlation between tests. J Thromb Haemost. 2008 Dec;6(12):2035-44. doi: 10.1111/j.1538-7836.2008.03184.x. Epub 2008 Oct 7.

  PMID: 18983514 BACKGROUND

• Heistein LC, Scott WA, Zellers TM, Fixler DE, Ramaciotti C, Journeycake JM, Lemler MS. Aspirin resistance in children with heart disease at risk for thromboembolism: prevalence and possible mechanisms. Pediatr Cardiol. 2008 Mar;29(2):285-91. doi: 10.1007/s00246-007-9098-7. Epub 2007 Sep 25.

  PMID: 17896127 BACKGROUND

• Szczeklik A, Musial J, Undas A, Sanak M, Nizankowski R. Aspirin resistance. Pharmacol Rep. 2005;57 Suppl:33-41.

  PMID: 16415485 BACKGROUND

• Frelinger AL 3rd, Furman MI, Linden MD, Li Y, Fox ML, Barnard MR, Michelson AD. Residual arachidonic acid-induced platelet activation via an adenosine diphosphate-dependent but cyclooxygenase-1- and cyclooxygenase-2-independent pathway: a 700-patient study of aspirin resistance. Circulation. 2006 Jun 27;113(25):2888-96. doi: 10.1161/CIRCULATIONAHA.105.596627. Epub 2006 Jun 19.

  PMID: 16785341 BACKGROUND

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Dongngan Truong, MD

  University of Utah / Primary Children's Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Cardiology Fellow

Study Record Dates

• First Submitted: July 26, 2012
• First Posted: August 3, 2012
• Study Start: November 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 5, 2017

Record last verified: 2017-05

Locations

US (1)