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

Coronary Artery Occlusive Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01067638
• Other study ID #: 4-2009-0488
• Status: Completed
• Phase: Phase 4
• First received: January 15, 2010
• Last updated: December 3, 2010
• Start date: November 2009
• Est. completion date: September 2010

Study information

• Verified date: December 2010
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Occlusive Disease

Intervention

Drug:
• Tranexamic Acid
1.0g loading dose before skin incision and continuous infusion 200 mg/h during surgery

Locations

Country	Name	City	State
Korea, Republic of	Yonsei Univ.	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tranexamic acid significantly reduce the amount and incidence of homologous transfusion in anemic patients undergoing off-pump coronary artery bypass (OPCAB)		Check the amount 3 times before sugery and 24 hours after surgery	Yes