Condition congenital heart disease
Treatments discarded blood samples, discarded urine sample
Sponsor Boston Children’s Hospital
Start date April 2015
End date March 2017
Trial size 100 participants
Trial identifier NCT02410473, P00016625


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.

Recruiting in the following locations…

United States Massachusetts
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Evaluate newer technologies for coagulation diagnostics with the aim to standardize bleeding management in high risk cardiac patients
time frame: 1 year

Eligibility Criteria

Male or female participants of any age.

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)

Additional Information

Official title Evaluation of Coagulation Testing in Patients Undergoing Cardiac Surgery
Principal investigator Juan Ibla, MD
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by Boston Children’s Hospital.