Tranexamic Acid in Pediatric Cardiac Surgery (TXA)

Okayama University

Status: Completed

Conditions: Congenital Heart Disease; Blood Loss

Treatments: Drug: Tranexamic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT00994994

Ped Txa Cya

Details and patient eligibility

About

Tranexamic acid(TXA) is an antifibrinolytic agent to reduce blood loss in cardiac surgery. Previous seven RCTs comparing effects of TXA in pediatric cardiac surgery showed conflict results. The reason why they showed mixed results would be the imbalance of patients population with regard to presence of cyanosis. TXA would reduce blood loss in pediatric cardiac surgery with well balanced patients population.

Enrollment: 160 patients

Sex: All

Ages: 2 months to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• children undergoing elective cardiac surgery with cardiopulmonary bypass

Exclusion criteria

• neonate born within 1 month
• preoperative inotropes
• preoperative mechanical ventilation
• preexisting coagulation disorder
• reoperation within 48 hours
• significant liver or kidney disease
• known allergy to TXA

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

160 participants in 2 patient groups, including a placebo group

Tranexamic acid

Active Comparator group

Description:

50 mg/kg of tranexamic acid was given as a bolus at the induction of anesthesia, followed by 15 mg/kg of continuous infusion and another 50 mg/kg into the bypass circuit.

Treatment:

Drug: Tranexamic Acid

Placebo

Placebo Comparator group

Description:

same volume of normal saline was given.

Treatment:

Drug: Tranexamic Acid