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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on November 25, 2014