Tranexamic Acid in Pediatric Cardiac Surgery

NCT ID: NCT00994994

Last Updated: 2009-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2008-04-30

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.

Conditions

Blood Loss; Congenital Heart Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Tranexamic Acid

Intervention Type: 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.

Placebo

same volume of normal saline was given.

Group Type: PLACEBO_COMPARATOR

Tranexamic Acid

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

transamine; antifibrinolytic; lysin analogue

Eligibility 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

• Minimum Eligible Age: 2 Months
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Okayama University

OTHER

Sponsor Role: lead

Responsible Party

Dept. of Anesthesiology, Okayama University Hospital

Principal Investigators

Yuichiro Toda, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology and Intensive Care, Okayama University Hospital

References

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.

Reference Type: DERIVED

PMID: 21947753 (View on PubMed)

Other Identifiers

Ped Txa Cya

Identifier Type: -

Identifier Source: org_study_id