Tranexamic Acid in Pediatric Cardiac Surgery

Congenital Heart Disease Clinical Trial

— TXA  

Official title:

Tranexamic Acid Reduces Blood Loss in Pediatric Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00994994
• Other study ID #: Ped Txa Cya
• Status: Completed
• Phase: N/A
• First received: October 13, 2009
• Last updated: October 13, 2009
• Start date: January 2006
• Est. completion date: April 2008

Study information

• Verified date: October 2009
• Source: Okayama University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: April 2008
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Months to 18 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blood Loss
• Congenital Heart Disease
• Heart Defects, Congenital
• Hemorrhage

Intervention

Drug:
• 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 in TXA group. same volume of normal saline was given in Placebo group.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Okayama University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the amount of blood loss (mediastinal and pericardial tube drainage) 24 hours after surgery		24 hours after surgery	No
Secondary	blood loss 6 hours after surgery		6 hours after surgery	No
Secondary	the amount of blood transfusion		24 hour after surgery	No
Secondary	additional TXA administration		24 hours after surgery	No
Secondary	chest closure time (protamine to skin closure)		at the end of surgery	No
Secondary	re-exploration of chest for excess bleeding		within 24 hours after surgery	No
Secondary	duration of mechanical ventilation		at the time of extubation	No
Secondary	length of stay in intensive care unit		at the time of discharge from ICU	No
Secondary	episode of thrombotic complication		from drug administration to hospital discharge	Yes