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Thromboelastogram During Total Knee Replacement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02373969
Recruitment Status : Completed
First Posted : February 27, 2015
Last Update Posted : April 6, 2016
Sponsor:
Information provided by (Responsible Party):
Rambam Health Care Campus

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

Condition or disease
Orthopedic Procedures, Tranexamic Acid

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.

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Thromboelastogram During Surgery for Total Knee Replacement With Tourniquet Application and Single Dose Tranexamic Acid
Study Start Date : August 2011
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement




Primary Outcome Measures :
  1. Change in coagulation status during and after surgery compared to pre-surgery [ Time Frame: During and after surgery compared to pre-surgery ]
  2. Change in fibrinolytic activity during and after surgery compared to pre-surgery [ Time Frame: During and after surgery compared to pre-surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
As described in eligibility criteria
Criteria

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
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Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT02373969    
Other Study ID Numbers: TEG-099-11
First Posted: February 27, 2015    Key Record Dates
Last Update Posted: April 6, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No