A Pilot Study Comparing Anti-Inflammatory Effects Of TXA Versus EACA In Pediatric Congenital Heart Surgery

Completed · Phase 4

Conditions studied: Pediatric Cardiac Surgery, Complication of Extracorporeal Circulation

In brief

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.

Key facts

Study ID: NCT02656472
Run by: Wake Forest University Health Sciences
People needed: 22
Starts: 2016-02-01
Expected to finish: 2017-04-01
Last updated by the study team: 2024-10-24

Who can join

Age: 0 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients undergoing pediatric cardiac surgery, with redo sternotomy needing cardiopulmonary bypass

You may not qualify if…

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)

Where it is running

Advocate Childrens Hospital — Oak Lawn, Illinois, United States

Full record on ClinicalTrials.gov

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