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

December 3, 2010 updated by: Yonsei University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Check the amount 3 times before sugery and 24 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

January 15, 2010

First Submitted That Met QC Criteria

February 10, 2010

First Posted (Estimate)

February 11, 2010

Study Record Updates

Last Update Posted (Estimate)

December 6, 2010

Last Update Submitted That Met QC Criteria

December 3, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2009-0488

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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