Skip to main content
OpenTrials
Completed

NCT Number: NCT00994994

Tranexamic Acid in Pediatric Cardiac Surgery

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Blood Loss Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital Heart Disease Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

2 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tranexamic Acid

Drug

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.

Other names: transamine, antifibrinolytic, lysin analogue

Primary outcomes

  1. the amount of blood loss (mediastinal and pericardial tube drainage) 24 hours after surgery

    Time frame: 24 hours after surgery

Secondary outcomes

  1. blood loss 6 hours after surgery

    Time frame: 6 hours after surgery

  2. the amount of blood transfusion

    Time frame: 24 hour after surgery

  3. additional TXA administration

    Time frame: 24 hours after surgery

  4. chest closure time (protamine to skin closure)

    Time frame: at the end of surgery

  5. re-exploration of chest for excess bleeding

    Time frame: within 24 hours after surgery

  6. duration of mechanical ventilation

    Time frame: at the time of extubation

  7. length of stay in intensive care unit

    Time frame: at the time of discharge from ICU

  8. episode of thrombotic complication

    Time frame: from drug administration to hospital discharge

Sponsors and collaborators

Lead sponsor

Okayama University

Other

Registry information

Official study title

Tranexamic Acid Reduces Blood Loss in Pediatric Cardiac Surgery

Acronym: TXA

Important dates

Study start
2006
Primary completion
2007
Study completion
2008
First posted
Oct 14, 2009
Registry last updated
Oct 14, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.