Tranexamic Acid in Pediatric Cardiac Surgery

Not Applicable

Completed

• Conditions: Blood Loss; Congenital Heart Disease
• Interventions: Drug: Tranexamic Acid

• Registration Number: NCT00994994
• Lead Sponsor: Okayama University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Primary Completion: 2007-08
• Study Completion: 2008-04
• Status Verified: 2009-10
• Study First Submitted: 2009-10-13
• Study First Submitted QC: 2009-10-13
• Last Update Submitted: 2009-10-13
• Study First Posted: 2009-10-14
• Last Update Posted: 2009-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tranexamic acid	Tranexamic Acid	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.
Placebo	Tranexamic Acid	same volume of normal saline was given.

Primary Outcome Measures

Name	Time	Method
the amount of blood loss (mediastinal and pericardial tube drainage) 24 hours after surgery	24 hours after surgery

Secondary Outcome Measures

Name	Time	Method
episode of thrombotic complication	from drug administration to hospital discharge
length of stay in intensive care unit	at the time of discharge from ICU
blood loss 6 hours after surgery	6 hours after surgery
the amount of blood transfusion	24 hour after surgery
additional TXA administration	24 hours after surgery
re-exploration of chest for excess bleeding	within 24 hours after surgery
duration of mechanical ventilation	at the time of extubation
chest closure time (protamine to skin closure)	at the end of surgery