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

• Status: Completed
• Trial end date: 2017-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare anti-inflammatory effects of two anti-fibrinolyntic drugs (Tranexamic acid versus Epsilon-aminocaproic acid) in pediatric patients undergoing pediatric cardiac surgery.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Andrew VanBergen, MD
• Treatments: Aminocaproic Acid; Anti-Inflammatory Agents; Tranexamic Acid

Criteria

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)