Evaluation of Coagulation Testing in Patients Undergoing Cardiac Surgery



Status:Active, not recruiting
Conditions:Peripheral Vascular Disease, Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:6/3/2018
Start Date:April 2015
End Date:December 2018

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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.


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)
We found this trial at
1
site
300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Phone: 617-355-7737
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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mi
from
Boston, MA
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