A Pilot Study Comparing Anti-Inflammatory Effects Of TXA Versus EACA In Pediatric Congenital Hear… (NCT02656472) | Clinical Trial Compass
CompletedPhase 4
A Pilot Study Comparing Anti-Inflammatory Effects Of TXA Versus EACA In Pediatric Congenital Heart Surgery
United States22 participantsStarted 2016-02
Plain-language summary
The purpose of this study is to compare anti-inflammatory effects of two anti-fibrinolytic drugs (Tranexamic acid versus Epsilon-aminocaproic acid) in pediatric patients undergoing pediatric cardiac surgery.
Who can participate
Age range3 Months – 17 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients undergoing pediatric cardiac surgery, with redo sternotomy needing cardiopulmonary bypass
Exclusion Criteria:
* Patients undergoing Fontan or Glenn procedures
* Allergy to EACA or TXA
* Baseline coagulation profile abnormality \* (The coagulation profile will be used as an exclusion criteria, if results available. Occasionally the results of coagulation profile may be unavailable prior to surgery due to a clotted sample. For such patients, as per the current clinical practice, we would not be redrawing the lab solely for a research purpose)
* Prothrombin time (PT) \>50% of High Normal value
* Partial Thromboplastin Time (PTT) \> 50% of High Normal value
* Platelets \< 50,000/mm3
* International normalized ratio (INR) \>2
* Acute or chronic renal failure (creatinine \> 2x high normal for age)
* Chronic hepatopathy (any transaminase \> 2x high normal for age)
* Use of immunosuppressant drugs (within last 1 month)
* History of seizures (currently on antiepileptic drugs for epilepsy or history of seizure within last 6 months)