Tranexamic Acid (TXA) in Pediatric Cardiac Surgery

Tranexamic Acid (TXA) During Pediatric Cardiac Surgery: A Prospective Randomised Study Comparing Two Dosing Regimens

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01141127

Acronym

Exacyl

Enrollment

Registered

2010-06-10

Start date

2010-06-30

Completion date

2011-12-31

Last updated

2014-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bleeding

Keywords

tranexamic acid in pediatric surgery, fibrinolysis and paediatric cardiac surgery

Brief summary

The purpose of this study is to determine tranexamic acid plasma levels in children undergoing cardiac surgery at risk of bleeding and to compare two dosing regimens.

Detailed description

Tranexamic acid (TXA) is administered intravenously to prevent bleeding associated with cardiac surgery and by pass in adult and children. The pharmacokinetic of this product is unknown in the pediatric population. Only a few studies report a clinical efficacy with different dosages. The purpose of this study is to determine the plasma level of TXA using two different administrations methods: continuous versus intermittent. The second objective is to determine whether fibrinolysis decreased. The population consists in children weighting 10 to 30 Kilos, undergoing cardiac surgery and at high risk of bleeding.

Interventions

DRUGTranexamic Acid

Comparison of two dosage regimen of Tranexamic Acid

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

12 Months to 12 Years

Healthy volunteers

Inclusion criteria

* children weighing between 10 and 30kg surgery with cardiopulmonary bypass for congenital heart disease deemed hemorrhagic

Exclusion criteria

* the patients undergoing a surgical procedure short and simple * patients with past history of convulsions neurologiques especially allergies to the TA * patients with renal insufficiency

Design outcomes

Primary

Measure	Time frame
Preoperative plasma tranexamic acid concentration is measured using high performance liquid chromatography	Blood samples are collected during the operative period within 24 hours

Secondary

Measure	Time frame
preoperative plasma tranexamic acid concentration is measured using high performance liquid chromatography	blood samples collected during the operative period within the first 24 hours

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026