Tranexamic Acid in Pediatric Cardiac Surgery (TXA)

O

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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