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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:
Information provided by:
Yonsei University
ClinicalTrials.gov Identifier:
NCT01067638
First received: January 15, 2010
Last updated: December 3, 2010
Last verified: December 2010
History of Changes
  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
Endpoint Classification: Efficacy Study
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01067638

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

No publications provided

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
Study First Received: January 15, 2010
Last Updated: December 3, 2010
Health Authority: South Korea: Institutional Review Board

Additional relevant MeSH terms:
Postoperative Hemorrhage
Hemorrhage
Pathologic Processes
Postoperative Complications
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 May 19, 2013