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Tranexamic Acid in Off-pump Coronary Surgery (TAOPCAB)

This study has been completed.
Sponsor:
Information provided by:
Cardiovascular Institute & Fuwai Hospital
ClinicalTrials.gov Identifier:
NCT01064167
First received: February 4, 2010
Last updated: January 11, 2011
Last verified: February 2010
History of Changes
  Purpose

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.


Condition Intervention
Off Pump Coronary Artery Bypass Surgery
 Drug: Tranexamic Acid

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Tranexamic Acid Reduces Blood Loss After Off-pump Coronary Artery Bypass Grafting

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Cardiovascular Institute & Fuwai Hospital:

Primary Outcome Measures:
  • Number of Patients Required Allogenic Red Blood Cells Transfusion [ Time Frame: 1month postoperative ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Postoperative Chest Tube Drainage [ Time Frame: 24h postoperative ] [ Designated as safety issue: No ]

Enrollment: 231
Study Start Date: February 2009
Study Completion Date: December 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tranexamic Acid group Drug: Tranexamic Acid
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.
Placebo Comparator: Control group Drug: Tranexamic Acid
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.

Detailed Description:

Cardiac surgical procedures account for a large amount of allogeneic transfusion. Although postoperative bleeding seems to be attenuated by the avoidance of cardiopulmonary bypass (CPB), hemorrhagic complications are not completely eliminated and the consequent need for allogeneic transfusions are still major problems after OPCAB.

Tranexamic acid, a synthetic antifibrinolytic drug, has been shown to reduce blood loss and transfusion requirements in cardiac surgery with CPB. About 30% of patients in OPCAB studies still receive a transfusion. A few small sample size studies concerned with the use of in OPCAB surgery, found that tranexamic acid appear to be effective in reducing postoperative bleeding, however, the results on transfusion requirements are still inconsistency. The purpose of this study was to evaluate the effects of tranexamic acid on the postoperative bleeding and transfusion requirements in a larger number of patients undergoing OPCAB surgery. In addition, the effect of tranexamic acid on mortality, morbidity and resource utilization was examined.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients for elective offpump coronary artery bypass surgery

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
  • Myocardial infarction < 7 days before surgery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01064167

Locations
China
Cardiovascular Institute and Fuwai Hospital
Beijing, China, 100037
Sponsors and Collaborators
Cardiovascular Institute & Fuwai Hospital
Investigators
Study Chair: Lihuan Li, M.D Fuwai Hospital
  More Information

No publications provided by Cardiovascular Institute & Fuwai Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Lihuan Li/Professor & Chief, Dep. of anesthesiology, Cardiovascular Institute and Fuwai Hospital, CAMS and PUMC
ClinicalTrials.gov Identifier: NCT01064167     History of Changes
Other Study ID Numbers: FWMZ013
Study First Received: February 4, 2010
Results First Received: August 30, 2010
Last Updated: January 11, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by Cardiovascular Institute & Fuwai Hospital:
Tranexamic Acid
off-pump coronary Artery Bypass

Additional relevant MeSH terms:
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013