Current Environment:

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

Recruitment Status

Active, not recruiting

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)

Intervention

Intervention Type

Intervention Name

Other

Discarded blood samples

Other

Discarded Urine Sample

Gender

All

Minimum Age

N/A

Maximum Age

N/A

Download Date

May 12, 2022

Principal Investigator

Juan Ibla

Primary Contact Information

For more information on this trial, visit clinicaltrials.gov.

Contact

For more information and to contact the study team: