Determination of the Minimal Concentration of Antifibrinolytics Required to Inhibit t-PA-activated Fibrinolysis

Boston Children's Hospital40 enrolled

Overview

Lysine analogs, like tranexamic acid (TXA) or epsilon aminocaproic acid (EACA), are antifibrinolytic agents routinely administered in children undergoing different surgeries associated with a high bleeding risk (e.g. cardiac, craniofacial, and orthopedic surgeries). Although there is a growing literature regarding the pharmacokinetic characteristics of these drugs in children, the plasmatic concentration required to completely inhibit fibrinolysis remains to be determined. In this in vitro study, the investigators will use an experimental model of fibrinolysis designed for rotational thromboelastometry (ROTEM®) to determine the minimal concentration inhibiting fibrinolysis for both TXA and EACA. In addition, this study will be used to create and validate a new experimental assay to measure fibrinolysis and the effect of antifibrinolytic agents.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Congenital Heart Disease Fibrinolysis Rotational Thromboelastometry

Interventions

Eligibility

Sex: ALLMin age: 2 MonthsMax age: 12 Months

Medical Language ↔ Plain English

Inclusion Criteria: * infants between 2 months of age and equal to or less than 12 months of age * weigh over 5.0 kg * either have CHD and are scheduled to undergo an elective cardiac catheterization lab procedure or do not have CHD and are scheduled to undergo a non-cardiac surgery (such as craniofacial surgery, neurosurgery, or orthopedic surgery) in the operating room Exclusion Criteria: * undergoing an emergent procedure, * child in a moribund condition (American Society of Anesthesiology (ASA 5) * children with a hematological and/or oncological disease * Jehovah witnesses * children with preoperative coagulopathy, defined as a platelet count \< 100,000/μL, fibrinogen level \< 100 mg/dL, prothrombin time (PT) and activated partial thromboplastin time (PTT) \> 1.5 normal range

Outcomes

Primary Outcomes

Concentration of antifibrinolytics associated with a complete inhibition of t-PA activated fibrinolysis confirmed by EXTEM test and the Star-TEM test.

Time frame: One Year