Tranexamic Acid in Pediatric Cardiac Surgery
TXA
Tranexamic Acid Reduces Blood Loss in Pediatric Cardiac Surgery
1 other identifier
interventional
160
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2006
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 13, 2009
CompletedFirst Posted
Study publicly available on registry
October 14, 2009
CompletedOctober 14, 2009
October 1, 2009
1.6 years
October 13, 2009
October 13, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the amount of blood loss (mediastinal and pericardial tube drainage) 24 hours after surgery
24 hours after surgery
Secondary Outcomes (8)
blood loss 6 hours after surgery
6 hours after surgery
the amount of blood transfusion
24 hour after surgery
additional TXA administration
24 hours after surgery
chest closure time (protamine to skin closure)
at the end of surgery
re-exploration of chest for excess bleeding
within 24 hours after surgery
- +3 more secondary outcomes
Study Arms (2)
Tranexamic acid
ACTIVE COMPARATOR50 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.
Placebo
PLACEBO COMPARATORsame volume of normal saline was given.
Interventions
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.
Eligibility Criteria
You may qualify if:
- children undergoing elective cardiac surgery with cardiopulmonary bypass
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Shimizu K, Toda Y, Iwasaki T, Takeuchi M, Morimatsu H, Egi M, Suemori T, Suzuki S, Morita K, Sano S. Effect of tranexamic acid on blood loss in pediatric cardiac surgery: a randomized trial. J Anesth. 2011 Dec;25(6):823-30. doi: 10.1007/s00540-011-1235-z. Epub 2011 Sep 24.
PMID: 21947753DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yuichiro Toda, MD, PhD
Department of Anesthesiology and Intensive Care, Okayama University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 13, 2009
First Posted
October 14, 2009
Study Start
January 1, 2006
Primary Completion
August 1, 2007
Study Completion
April 1, 2008
Last Updated
October 14, 2009
Record last verified: 2009-10