Thromboelastogram During Total Knee Replacement

April 5, 2016 updated by: Rambam Health Care Campus

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

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

30

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

As described in eligibility criteria

Description

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 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in coagulation status during and after surgery compared to pre-surgery
Time Frame: 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
Time Frame: During and after surgery compared to pre-surgery
During and after surgery compared to pre-surgery

Collaborators and Investigators

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

Sponsor

Rambam Health Care Campus

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

August 1, 2011

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

February 22, 2015

First Submitted That Met QC Criteria

February 22, 2015

First Posted (Estimate)

February 27, 2015

Study Record Updates

Last Update Posted (Estimate)

April 6, 2016

Last Update Submitted That Met QC Criteria

April 5, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • TEG-099-11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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