Tranexamic Acid in Pediatric Cardiac Surgery (TXA)

October 13, 2009 updated by: Okayama University

Tranexamic Acid Reduces Blood Loss 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 months to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the amount of blood loss (mediastinal and pericardial tube drainage) 24 hours after surgery
Time Frame: 24 hours after surgery
24 hours after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Okayama University

Investigators

  • Principal Investigator: Yuichiro Toda, MD, PhD, Department of Anesthesiology and Intensive Care, Okayama University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (ACTUAL)

August 1, 2007

Study Completion (ACTUAL)

April 1, 2008

Study Registration Dates

First Submitted

October 13, 2009

First Submitted That Met QC Criteria

October 13, 2009

First Posted (ESTIMATE)

October 14, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

October 14, 2009

Last Update Submitted That Met QC Criteria

October 13, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ped Txa Cya

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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