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

Completed

• Conditions: Congenital Heart Disease; Fibrinolysis; Rotational Thromboelastometry
• Interventions: Other: Intraoperative Blood Sample

• Registration Number: NCT02352675
• Lead Sponsor: Boston Children's Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-26
• Study First Submitted QC: 2015-01-28
• Study First Posted: 2015-02-02
• Study Start: 2015-04
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-28
• Last Update Posted: 2017-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non Congenital Heart Disease	Intraoperative Blood Sample	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.
Congenital Heart Disease	Intraoperative Blood Sample	Infants with congenital heart disease (CHD) who are scheduled to undergo an elective cardiac catheterization lab procedure at Boston Children's Hospital

Primary Outcome Measures

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

Trial Locations

Locations (1)

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States