Tranexamic Acid in Off-pump Coronary Surgery
TAOPCAB
Tranexamic Acid Reduces Blood Loss After Off-pump Coronary Artery Bypass Grafting
1 other identifier
interventional
231
1 country
1
Brief Summary
The aim of this prospective, randomized, double-blinded, placebo-controlled study was to evaluate the effects of tranexamic acid, a synthetic antifibrinolytic drug, on the postoperative bleeding and transfusion requirements in patients undergoing off-pump coronary artery bypass graphing (OPCAB) surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2009
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 4, 2010
CompletedFirst Posted
Study publicly available on registry
February 8, 2010
CompletedResults Posted
Study results publicly available
February 3, 2011
CompletedFebruary 3, 2011
February 1, 2010
8 months
February 4, 2010
August 30, 2010
January 11, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Patients Required Allogenic Red Blood Cells Transfusion
1month postoperative
Secondary Outcomes (1)
Postoperative Chest Tube Drainage
24h postoperative
Study Arms (2)
Tranexamic Acid group
EXPERIMENTALControl group
PLACEBO COMPARATORInterventions
In tranexamic acid group, tranexamic acid, 1 g, was given 20 minutes before incision and 400 mg/h during the entire surgical procedure. The patients from control group were infused with normal saline as a placebo.
Eligibility Criteria
You may qualify if:
- Patients for elective offpump coronary artery bypass surgery
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
- Myocardial infarction \< 7 days before surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cardiovascular Institute and Fuwai Hospital
Beijing, 100037, China
Related Publications (1)
Wang G, Xie G, Jiang T, Wang Y, Wang W, Ji H, Liu M, Chen L, Li L. Tranexamic acid reduces blood loss after off-pump coronary surgery: a prospective, randomized, double-blind, placebo-controlled study. Anesth Analg. 2012 Aug;115(2):239-43. doi: 10.1213/ANE.0b013e3182264a11. Epub 2011 Jul 7.
PMID: 21737704DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Guyan Wang
- Organization
- Cardiovascular Institute & Fuwai Hospital
Study Officials
- STUDY CHAIR
Lihuan Li, M.D
Chinese Academy of Medical Sciences, Fuwai Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
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
Study Record Dates
First Submitted
February 4, 2010
First Posted
February 8, 2010
Study Start
February 1, 2009
Primary Completion
October 1, 2009
Study Completion
December 1, 2009
Last Updated
February 3, 2011
Results First Posted
February 3, 2011
Record last verified: 2010-02