Clinical trial NCT02410473: Evaluation of Coagulation Testing in Patients Undergoing Cardiac Surgery
Official title: Evaluation of Coagulation Testing in Patients Undergoing Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Congenital Heart Disease
Keywords: Congenital Heart Disease
Point-of-care coagulation monitoring
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2015-04-07
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neonates and infants undergoing cardiac surgery with cardiopulmonary bypass

Brief summary: Neonates, children with single ventricle congenital heart disease, and those undergoing multiple complex cardiac surgeries are at high risk of increased perioperative blood loss, and blood product transfusions. In addition, some of these patients will present an increased risk of postoperative thromboembolic complications. For a long time, bleeding management has been based on the empiric administration of different blood products (e.g. platelet concentrates, cryoprecipitates, and/or activated factor VII), topical hemostatic agents, and surgical manipulation. Recently, the use of viscoelastic tests (e.g. thromboelastography (TEG) or thromboelastometry (ROTEM)) increased, and allowed a better assessment of perioperative coagulopathy, and a more 'rational' treatment of bleeding. While TEG and ROTEM record the viscoelastic properties of whole blood by measuring mechanical impedance and related changes during clot formation, T2MR, a miniaturized, magnetic resonance-based diagnostic platform, measures how water molecules react in the presence of magnetic fields to evaluate a broad range of hemostasis measurements. In this study, we will prospectively collect demographic data, surgical characteristics, the amount of perioperative bleeding and blood product transfusion, results of laboratory assays, and postoperative outcomes (30-day follow-up or until discharge), with the aim to assess our current practice, and develop an algorithm-based approach for the administration of targeted blood product and pro-coagulant therapies. Our goals are: the reduction of blood product utilization, the reduction of the incidence of massive bleeding and postoperative thrombosis.


Eligibility criteria: Inclusion Criteria:

* Neonates and infant patients (0 -12 months of age) undergoing complex cardiac surgical procedures
* cardiac surgery patient \> 12 months of age who has previously undergone 2 or more sternotomies

Exclusion Criteria:

* child in a moribund condition (American Society of Anesthesiology (ASA 5)
* children with a hematological and/or oncological disease
* Jehovah witnesses
* If the child is only undergoing a patent ductus arteriosus (PDA) ligation or other procedures not considered at risk for thrombosis and/or bleeding or they do not provide consent for enrollment (e.g. Ventricular Septal Defect repair)

Primary outcomes:
measure: Evaluate newer technologies for coagulation diagnostics with the aim to standardize bleeding management in high risk cardiac patients
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Juan Ibla, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brummel-Ziedins K, Undas A, Orfeo T, Gissel M, Butenas S, Zmudka K, Mann KG. Thrombin generation in acute coronary syndrome and stable coronary artery disease: dependence on plasma factor composition. J Thromb Haemost. 2008 Jan;6(1):104-10. doi: 10.1111/j.1538-7836.2007.02799.x. Epub 2007 Oct 15.
citation: Eisses MJ, Chandler WL. Cardiopulmonary bypass parameters and hemostatic response to cardiopulmonary bypass in infants versus children. J Cardiothorac Vasc Anesth. 2008 Feb;22(1):53-9. doi: 10.1053/j.jvca.2007.06.006. Epub 2007 Aug 22.
citation: Emani S, Zurakowski D, Baird CW, Pigula FA, Trenor C 3rd, Emani SM. Hypercoagulability markers predict thrombosis in single ventricle neonates undergoing cardiac surgery. Ann Thorac Surg. 2013 Aug;96(2):651-6. doi: 10.1016/j.athoracsur.2013.04.061. Epub 2013 Jun 26.
citation: Fries D, Innerhofer P, Streif W, Schobersberger W, Margreiter J, Antretter H, Hormann C. Coagulation monitoring and management of anticoagulation during cardiac assist device support. Ann Thorac Surg. 2003 Nov;76(5):1593-7. doi: 10.1016/s0003-4975(03)01034-8.
citation: Koestenberger M, Cvirn G, Nagel B, Rosenkranz A, Leschnik B, Gamillscheg A, Beitzke A, Muntean W. Thrombin generation determined by calibrated automated thrombography (CAT) in pediatric patients with congenital heart disease. Thromb Res. 2008;122(1):13-9. doi: 10.1016/j.thromres.2007.08.016. Epub 2007 Oct 3.
citation: Livingston ER, Fisher CA, Bibidakis EJ, Pathak AS, Todd BA, Furukawa S, McClurken JB, Addonizio VP, Jeevanandam V. Increased activation of the coagulation and fibrinolytic systems leads to hemorrhagic complications during left ventricular assist implantation. Circulation. 1996 Nov 1;94(9 Suppl):II227-34.
citation: Nankervis CA, Preston TJ, Dysart KC, Wilkinson WD, Chicoine LG, Welty SE, Nelin LD. Assessing heparin dosing in neonates on venoarterial extracorporeal membrane oxygenation. ASAIO J. 2007 Jan-Feb;53(1):111-4. doi: 10.1097/01.mat.0000247777.65764.b3.
citation: Tappenden KA, Gallimore MJ, Evans G, Mackie IJ, Jones DW. Thrombin generation: a comparison of assays using platelet-poor and -rich plasma and whole blood samples from healthy controls and patients with a history of venous thromboembolism. Br J Haematol. 2007 Oct;139(1):106-12. doi: 10.1111/j.1365-2141.2007.06732.x.
citation: Vittinghoff E, McCulloch CE. Relaxing the rule of ten events per variable in logistic and Cox regression. Am J Epidemiol. 2007 Mar 15;165(6):710-8. doi: 10.1093/aje/kwk052. Epub 2006 Dec 20.