Dose-ranging Study of Tranexamic Acid in Valve Surgery

Hemorrhage Clinical Trial

Official title:

Comparison of Two Tranexamic Acid Dose Regimens on Postoperative Bleeding and Transfusion Needs in Primary Valve Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01191554
• Other study ID #: FW2009006
• Status: Completed
• Phase: N/A
• First received: August 30, 2010
• Last updated: November 2, 2012
• Start date: September 2010
• Est. completion date: October 2011

Study information

• Verified date: November 2012
• Source: Chinese Academy of Medical Sciences, Fuwai Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Cardiac surgical procedures account for a large amount of allogeneic transfusion. Tranexamic acid (TA), a synthetic antifibrinolytic drug, has been shown to reduce blood loss and transfusion requirements in cardiac surgery with Cardiopulmonary bypass. There are currently multiple dosing regimens for TA in cardiac surgery. Preliminary dose-response study has shown that low dose of TA would be as hemostatic efficacy as higher dose. Currently, no randomized study focus on TA in primary valve surgery. The aim of this prospective, double-blinded, randomized trial is to compare two dosing regimens of TA during primary valve surgery on perioperative blood loss and allogeneic blood transfusion.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: October 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• valvular disease patients requiring valvular replacement or repair surgery with cardiopulmonary bypass (CPB)

Exclusion Criteria:

• a history of bleeding disorders

• active chronic hepatitis or cirrhosis

• chronic renal insufficiency (serum creatinine > 2 mg/dl)

• preoperative anemia (Hb < 10 g/dl)

• previous cardiac surgery

• urgent and emergency surgery

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhage
• Valvular Heart Surgery

Intervention

Drug:
• Tranexamic Acid
High and low dosage. Loading dose followed by continuous infusion in operation.

Locations

Country	Name	City	State
China	Cardiovascular Institute and Fuwai Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of allogeneic red blood cells transfused		7 days post-operation	No
Secondary	Chest tube drainage		6 hours post-operation	No
Secondary	Chest tube drainage		24 hours post-operation	No