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Tranexamic Acid in Pediatric Cardiac Surgery (TXA)

This study has been completed.
Sponsor:
Information provided by:
Okayama University
ClinicalTrials.gov Identifier:
NCT00994994
First received: October 13, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Blood Loss
Congenital Heart Disease
 Drug: Tranexamic Acid

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
Official Title: Tranexamic Acid Reduces Blood Loss in Pediatric Cardiac Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Okayama University:

Primary Outcome Measures:
  • the amount of blood loss (mediastinal and pericardial tube drainage) 24 hours after surgery [ Time Frame: 24 hours after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • blood loss 6 hours after surgery [ Time Frame: 6 hours after surgery ] [ Designated as safety issue: No ]
  • the amount of blood transfusion [ Time Frame: 24 hour after surgery ] [ Designated as safety issue: No ]
  • additional TXA administration [ Time Frame: 24 hours after surgery ] [ Designated as safety issue: No ]
  • chest closure time (protamine to skin closure) [ Time Frame: at the end of surgery ] [ Designated as safety issue: No ]
  • re-exploration of chest for excess bleeding [ Time Frame: within 24 hours after surgery ] [ Designated as safety issue: No ]
  • duration of mechanical ventilation [ Time Frame: at the time of extubation ] [ Designated as safety issue: No ]
  • length of stay in intensive care unit [ Time Frame: at the time of discharge from ICU ] [ Designated as safety issue: No ]
  • episode of thrombotic complication [ Time Frame: from drug administration to hospital discharge ] [ Designated as safety issue: Yes ]

Enrollment: 160
Study Start Date: January 2006
Study Completion Date: April 2008
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
 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.
Other Names:
  • transamine
  • antifibrinolytic
  • lysin analogue
Placebo Comparator: Placebo
same volume of normal saline was given.
 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.
Other Names:
  • transamine
  • antifibrinolytic
  • lysin analogue

  Eligibility

Ages Eligible for Study:   2 Months to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00994994

Sponsors and Collaborators
Okayama University
Investigators
Principal Investigator: Yuichiro Toda, MD, PhD Department of Anesthesiology and Intensive Care, Okayama University Hospital
  More Information

No publications provided by Okayama University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Yuichiro Toda, Dept. of Anesthesiology, Okayama University Hospital
ClinicalTrials.gov Identifier: NCT00994994     History of Changes
Other Study ID Numbers: Ped Txa Cya
Study First Received: October 13, 2009
Last Updated: October 13, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Okayama University:
pediatric cardiac surgery
bleeding
tranexamic acid
fibrinolysis
blood loss in pediatric cardiac surgery

Additional relevant MeSH terms:
Heart Diseases
Hemorrhage
Heart Defects, Congenital
Cardiovascular Diseases
Pathologic Processes
Cardiovascular Abnormalities
Congenital Abnormalities
Antifibrinolytic Agents
 Tranexamic Acid
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 13, 2013