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
1 other identifier
interventional
90
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Nov 2009
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 15, 2010
CompletedFirst Posted
Study publicly available on registry
February 11, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedDecember 6, 2010
December 1, 2010
10 months
January 15, 2010
December 3, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
tranexamic acid
EXPERIMENTALTranexamic Acid on Postoperative Blood loss and Coagulation in Patients with Preoperative Anemia Undergoing Off-Pump Coronary Artery Bypass Graft
Interventions
1.0g loading dose before skin incision and continuous infusion 200 mg/h during surgery
Eligibility Criteria
You may qualify if:
- Fifty patients undergoing OPCAB with preoperative hematocrit levels lower than 35%
You may not qualify if:
- Patient who has
- Open heart surgery history before
- Thrombosis history
- Myocardial infarction (MI) within 7days recently
- Liver or Kidney disease
- been scheduled emergency surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yonsei Univ.
Seoul, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 15, 2010
First Posted
February 11, 2010
Study Start
November 1, 2009
Primary Completion
September 1, 2010
Study Completion
September 1, 2010
Last Updated
December 6, 2010
Record last verified: 2010-12