Thromboelastogram During Total Knee Replacement

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

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Key information

Conditions

Orthopedic Procedures, Tranexamic Acid

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Change in coagulation status during and after surgery compared to pre-surgery

Time frame: During and after surgery compared to pre-surgery
Change in fibrinolytic activity during and after surgery compared to pre-surgery

Time frame: During and after surgery compared to pre-surgery

Sponsors and collaborators

Lead sponsor

Rambam Health Care Campus

Other

Registry information

Official study title

Thromboelastogram During Surgery for Total Knee Replacement With Tourniquet Application and Single Dose Tranexamic Acid

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Feb 27, 2015
Registry last updated: Apr 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.