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The Effect of Tranexamic Acid on Postoperative Blood Loss and Coagulation in Patients With Preoperative Anemia Undergoing Off-Pump Coronary Artery Bypass Graft; Double Blind Randomized Control Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01067638
First Posted: February 11, 2010
Last Update Posted: December 6, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Yonsei University
  Purpose
The Effect of Tranexamic Acid on Postoperative Blood loss and Coagulation in Patients with Preoperative Anemia Undergoing Off-Pump Coronary Artery Bypass Graft; double blind randomized control study.

Condition Intervention Phase
Coronary Artery Occlusive Disease Drug: Tranexamic Acid Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Tranexamic acid significantly reduce the amount and incidence of homologous transfusion in anemic patients undergoing off-pump coronary artery bypass (OPCAB) [ Time Frame: Check the amount 3 times before sugery and 24 hours after surgery ]

Enrollment: 90
Study Start Date: November 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: tranexamic acid
Tranexamic Acid on Postoperative Blood loss and Coagulation in Patients with Preoperative Anemia Undergoing Off-Pump Coronary Artery Bypass Graft
Drug: Tranexamic Acid
1.0g loading dose before skin incision and continuous infusion 200 mg/h during surgery

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Fifty patients undergoing OPCAB with preoperative hematocrit levels lower than 35%

Exclusion Criteria:

Patient who has

  • Open heart surgery history before
  • Thrombosis history
  • Myocardial infarction (MI) within 7days recently
  • Liver or Kidney disease
  • been scheduled emergency surgery
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01067638


Locations
Korea, Republic of
Yonsei Univ.
Seoul, Korea, Republic of
Sponsors and Collaborators
Yonsei University
  More Information

Responsible Party: Kwak, Young-Lan, Severance Hospital, Dept. of Anesthesiology & Pain Medicine
ClinicalTrials.gov Identifier: NCT01067638     History of Changes
Other Study ID Numbers: 4-2009-0488
First Submitted: January 15, 2010
First Posted: February 11, 2010
Last Update Posted: December 6, 2010
Last Verified: December 2010

Additional relevant MeSH terms:
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants