Determination of the Minimal Concentration of Antifibrinolytics Required to Inhibit t-PA-activated Fibrinolysis
This trial is active, not recruiting.
|Conditions||congenital heart disease, fibrinolysis, rotational thromboelastometry|
|Treatment||intraoperative blood sample|
|Sponsor||Children's Hospital Boston|
|Start date||April 2015|
|End date||April 2016|
|Trial size||80 participants|
|Trial identifier||NCT02352675, P00016186|
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.
|Observational model||case control|
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
Male or female participants from 2 months up to 12 months old.
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
|Official title||Determination of the Minimal Concentration of Antifibrinolytics Required to Inhibit t-PA-activated Fibrinolysis Using an in Vitro Experimental Model of Fibrinolysis.|
|Principal investigator||David Faraoni, MD|
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