Phase 4
N=21
A Pilot Study Comparing Anti-Inflammatory Effects Of TXA Versus EACA In Pediatric Congenital Heart Surgery
Pediatric Cardiac Surgery · Complication of Extracorporeal Circulation
Bottom Line
View on ClinicalTrials.gov: NCT02656472 ↗Enrolled (actual)
21
Serious AEs
5.0%
Results posted
Oct 2024
Primary outcome: Primary: Inflammatory Markers/Cytokines — 1.5; 2.1; 1.6; 2.2 pg/dl
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Tranexamic acid (Drug); Epsilon Aminocaproic Acid (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Inflammatory Markers/Cytokines |
1.5; 2.1; 1.6; 2.2; 0.4; 0.6 | — |
| SECONDARY Chest Tube Output |
5.1; 7.8 | — |
| SECONDARY Blood Replacement Volume |
0.0; 0.0; 2.0; 1.4; 0.0; 0.0 | — |
| SECONDARY Platelet Levels |
163.7; 185.1; 124.8; 162.8 | — |
| SECONDARY Liver Enzymes |
131.8; 119.3; 254.8; 175.1; 36.6; 74.5 | — |
| SECONDARY Hemoglobin |
10.2; 11.1; 10.3; 9.9 | — |
| SECONDARY Creatinine |
0.6; 0.6; 0.5; 0.7 | — |
| SECONDARY Length of Stay |
4.0; 2.0; 4.0; 3.5 | — |
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.
Eligibility 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 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)
Data sourced from ClinicalTrials.gov (NCT02656472). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.