Evaluation of Coagulation Testing in Patients Undergoing Cardiac Surgery

NCT02410473 | Unknown

• 1 other identifier: P00016625
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Heart Disease

Keywords

Congenital Heart Disease; Point-of-care coagulation monitoring

Outcome Measures

Primary Outcomes (1)

• Evaluate newer technologies for coagulation diagnostics with the aim to standardize bleeding management in high risk cardiac patients

  1 year

Interventions

Discarded blood samples OTHER

Will utilize the discarded blood from routine clinical blood samples to evaluate the input of the newer technologies that helped for the diagnostic of coagulopathy.

Discarded Urine Sample OTHER

Will utilized the discarded urine samples from the routinely placed Foley catheter to measure the indices of oxidative stress.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Neonates and infants undergoing cardiac surgery with cardiopulmonary bypass

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (9)

• 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.

  PMID: 17944993 BACKGROUND

• 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.

  PMID: 18249331 BACKGROUND

• 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.

  PMID: 23809731 BACKGROUND

• 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.

  PMID: 14602292 BACKGROUND

• 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.

  PMID: 17915295 BACKGROUND

• 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.

  PMID: 8901751 BACKGROUND

• 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.

  PMID: 17237658 BACKGROUND

• 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.

  PMID: 17854314 BACKGROUND

• 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.

  PMID: 17182981 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Collect discarded blood from 4 routine blood samples. These will be obtained at 4 different time-points: 1. After induction of anesthesia and placement of arterial line, 2. After cardiopulmonary Bipass (CPB), 3 minutes after protamine administration, 3. At the end of the surgery, before transfer to CICU, 4. 24- 48 hrs post-surgery in the ICU. Collect two 5 mL of urine samples. One sample prior to CPB, as well as following CPB, from an routinely placed Foley catheter.

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

• Juan Ibla, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiac Anesthesiologist

Study Record Dates

• First Submitted: April 2, 2015
• First Posted: April 7, 2015
• Study Start: April 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: December 1, 2023
• Last Updated: January 10, 2023

Record last verified: 2023-01

Locations

US (1)