Determination of the Minimal Concentration of Antifibrinolytics Required to Inhibit t-PA-activated Fibrinolysis
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 3/16/2015 |
| Start Date: | February 2015 |
| End Date: | February 2016 |
| Contact: | David Faraoni, MD |
| Email: | david.faraoni@childrens.harvard.edu |
| Phone: | +1 (617) 919-3445 |
Determination of the Minimal Concentration of Antifibrinolytics Required to Inhibit t-PA-activated Fibrinolysis Using an in Vitro Experimental Model of Fibrinolysis.
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.
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.
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
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Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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