Thromboelastogram During Total Knee Replacement

Completed

• Conditions: Orthopedic Procedures, Tranexamic Acid

• Registration Number: NCT02373969
• Lead Sponsor: Rambam Health Care Campus

Brief Summary

Verify the changes in coagulation system during total knee replacement surgery with tranexamic acid single bolus infusion.

Detailed Description

The study was set to reveal changes in the coagulation and fibrinolytic systems during total knee surgery and especially during tourniquet placement, tourniquet removal and revascularization of ischemic limb, after tranexamic acid single bolus infusion, and at post operative day 1.

Study Timeline

• Study Start: 2011-08
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Study First Submitted: 2015-02-22
• Study First Submitted QC: 2015-02-22
• Study First Posted: 2015-02-27
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-05
• Last Update Posted: 2016-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Osteoarthrosis
• TKR operation elective
• ASA I-III

Exclusion Criteria

• TKR due to any reason but osteoarthrosis
• known coagulation problems
• platelets < 100,000/DcL
• Hb < 12 g%
• past thrombo-embolic event
• treatment with aspiring during last week
• treatment with NSAID's during last 48 hours
• malignancy
• known allergy to tranexamic acid
• general anesthesia

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in coagulation status during and after surgery compared to pre-surgery	During and after surgery compared to pre-surgery
Change in fibrinolytic activity during and after surgery compared to pre-surgery	During and after surgery compared to pre-surgery