NCT02352675

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

Determination of the Minimal Concentration of Antifibrinolytics Required to Inhibit t-PA-activated Fibrinolysis Using an in Vitro Experimental Model of Fibrinolysis.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 40 (actual)
• Sponsor: Boston Children's Hospital · Academic / Other
• Sex: All
• Age: 2 Months – 12 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Congenital Heart Disease
• Fibrinolysis
• Rotational Thromboelastometry

Interventions

Type	Name	Description
OTHER	Intraoperative Blood Sample	Blood sample will be run using rotational thromboelastometry to determine the minimal concentration of TXA and EACA need to inhibit fibrinolysis

Timeline

• Start date: 2015-04-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2015-02-02
• Last updated: 2017-08-01

Locations

1 site across 1 country: United States