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

Boston Children's Hospital

Status: Completed

Conditions: Fibrinolysis; Rotational Thromboelastometry; Congenital Heart Disease

Treatments: Other: Intraoperative Blood Sample

Study type: Observational

Funder types: Other

Identifiers

NCT02352675

P00016186

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 2 to 12 months old

Volunteers: No Healthy Volunteers

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

Trial design

40 participants in 2 patient groups

Congenital Heart Disease

Description:

Infants with congenital heart disease (CHD) who are scheduled to undergo an elective cardiac catheterization lab procedure at Boston Children's Hospital

Treatment:

Other: Intraoperative Blood Sample

Non Congenital Heart Disease

Description:

Infants who do not have congenital heart disease (No-CHD) and are scheduled to undergo a non-cardiac surgery (such as craniofacial surgery, neurosurgery, or orthopedic surgery) in the operating room at Boston Children's Hospital.

Treatment:

Other: Intraoperative Blood Sample