Dose-ranging Study of Tranexamic Acid in Valve Surgery
Comparison of Two Tranexamic Acid Dose Regimens on Postoperative Bleeding and Transfusion Needs in Primary Valve Surgery
1 other identifier
interventional
175
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2010
1 active site
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
First Submitted
Initial submission to the registry
August 30, 2010
CompletedFirst Posted
Study publicly available on registry
August 31, 2010
CompletedStudy Start
First participant enrolled
September 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedNovember 6, 2012
November 1, 2012
1 year
August 30, 2010
November 2, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Frequency of allogeneic red blood cells transfused
7 days post-operation
Secondary Outcomes (2)
Chest tube drainage
6 hours post-operation
Chest tube drainage
24 hours post-operation
Study Arms (2)
High dosage
EXPERIMENTALA loading dose of 30 mg/kg and a maintenance infusion of 16 mg/kg through out the operation, and 2 mg/kg into the cardiopulmonary bypass (CPB) prime volume.
Low dosage
EXPERIMENTALA loading dose of 10 mg/kg and a maintenance infusion of 1 mg/kg through out the operation, and 1 mg/kg into the cardiopulmonary bypass (CPB) prime volume.
Interventions
High and low dosage. Loading dose followed by continuous infusion in operation.
Eligibility Criteria
You may qualify if:
- valvular disease patients requiring valvular replacement or repair surgery with cardiopulmonary bypass (CPB)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cardiovascular Institute and Fuwai Hospital
Beijing, 100037, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Lihuan Li, M.D
Fuwai Hospital & Cardiovascular Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
August 30, 2010
First Posted
August 31, 2010
Study Start
September 1, 2010
Primary Completion
September 1, 2011
Study Completion
October 1, 2011
Last Updated
November 6, 2012
Record last verified: 2012-11