Evaluation of Coagulation Testing in Patients Undergoing Cardiac Surgery

NCT ID: NCT02410473

Last Updated: 2023-01-10

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2023-12-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: OTHER

Discarded Urine Sample

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

Intervention Type: OTHER

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)

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Juan Ibla

Cardiac Anesthesiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Juan Ibla, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

Boston Children's Hospital

Boston, Massachusetts, United States

Countries

United States

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Other Identifiers

P00016625

Identifier Type: -

Identifier Source: org_study_id