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

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

Sponsors

Lead sponsor: Boston Children’s Hospital

Source 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.

Overall Status Completed
Start Date April 2015
Completion Date March 2016
Primary Completion Date March 2016
Study Type Observational
Primary Outcome
Measure Time Frame
Concentration of antifibrinolytics associated with a complete inhibition of t-PA activated fibrinolysis confirmed by EXTEM test and the Star-TEM test. One Year
Enrollment 40
Condition
Intervention

Intervention type: Other

Intervention name: Intraoperative Blood Sample

Description: Blood sample will be run using rotational thromboelastometry to determine the minimal concentration of TXA and EACA need to inhibit fibrinolysis

Eligibility

Sampling method: Non-Probability Sample

Criteria:

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

Gender: All

Minimum age: 2 Months

Maximum age: 12 Months

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
David Faraoni, MD Principal Investigator Boston Children’s Hospital
Location
facility
Boston Children's Hospital
Location Countries

United States

Verification Date

July 2017

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Boston Children’s Hospital

Investigator full name: David Faraoni

Investigator title: Cardiac Anesthesiologist

Has Expanded Access No
Condition Browse
Arm Group

Arm group label: 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

Arm group label: 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.

Study Design Info

Observational model: Case-Control

Time perspective: Prospective

Source: ClinicalTrials.gov