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Evaluation of Coagulation Testing in Patients Undergoing Cardiac Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02410473
Recruitment Status : Active, not recruiting
First Posted : April 7, 2015
Last Update Posted : April 22, 2019
Information provided by (Responsible Party):
Juan Ibla, Boston Children’s Hospital

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.

Condition or disease Intervention/treatment
Congenital Heart Disease Other: Discarded blood samples Other: Discarded Urine Sample

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Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Coagulation Testing in Patients Undergoing Cardiac Surgery
Actual Study Start Date : April 2015
Actual Primary Completion Date : July 2017
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Intervention Details:
  • Other: Discarded blood samples
    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.
  • Other: Discarded Urine Sample
    Will utilized the discarded urine samples from the routinely placed Foley catheter to measure the indices of oxidative stress.

Primary Outcome Measures :
  1. Evaluate newer technologies for coagulation diagnostics with the aim to standardize bleeding management in high risk cardiac patients [ Time Frame: 1 year ]

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.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Neonates and infants undergoing cardiac surgery with cardiopulmonary bypass

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02410473

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United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children’s Hospital
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Principal Investigator: Juan Ibla, MD Boston Children’s Hospital


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Responsible Party: Juan Ibla, Cardiac Anesthesiologist, Boston Children’s Hospital Identifier: NCT02410473     History of Changes
Other Study ID Numbers: P00016625
First Posted: April 7, 2015    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019

Keywords provided by Juan Ibla, Boston Children’s Hospital:
Congenital Heart Disease
Point-of-care coagulation monitoring

Additional relevant MeSH terms:
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Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities