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Clinical Trials/NCT01355900
NCT01355900
Completed
Not Applicable

Influence of the Intraoperative Tourniquet Application Method on the Perioperative Blood Loss, Frequency of Transfusion and Close Postoperative Outcomes in Primary Total Knee Arthroplasty Patients

Vilnius University1 site in 1 country120 target enrollmentJanuary 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Knee Osteoarthritis
Sponsor
Vilnius University
Enrollment
120
Locations
1
Primary Endpoint
Perioperative blood loss.
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

Different strategies of tourniquet application during elective primary total knee arthroplasty are thought to be associated with different outcomes. In that context, the study investigates different tactics in the search of optimal application of the tourniquet and the related fluid management during 24 perioperative hours.

Detailed Description

The optimal application of tourniquet should reduce perioperative blood loss, create bloodless operative field, improve cementing technique and shorten surgery time. Meanwhile, inadequate application may increase the risk of deep vein thrombosis and pulmonary thromboembolism. Previous attempts to compare the tourniquet strategies in respect to the perioperative blood loss did not show significant difference. The investigators use the volume loading test aiming to optimize the fluid status and obtain the hemoglobin concentration in the conditions of standardized plasma dilution. The test is deployed just before the surgery and after postoperative 24 hrs in ICU. Functional outcomes and possible length of hospital stay is also evaluated.

Registry
clinicaltrials.gov
Start Date
January 2010
End Date
January 2014
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Narunas Porvaneckas

Pofessor, PhD

Vilnius University

Eligibility Criteria

Inclusion Criteria

  • Patients with osteoarthritis of the knee undergoing total knee arthroplasty with spinal-epidural anesthesia
  • Age \> 50 and \< 80 years
  • ASA (American Society of Anesthesiology Classification) II physical status
  • Signed informed consent form

Exclusion Criteria

  • History of a bleeding disorder
  • Current chronic anticoagulation therapy
  • History of DVT (Deep Vein Thrombosis), thromboembolic complications, acute cardiac insufficiency
  • Anemia before surgery required blood transfusion
  • ASA I, ASA\>=III physical status
  • Age \< 50 and \> 80 years
  • BMI (Body Mass Index) \< 20 and \> 40kg/m2
  • Intravascular fluid infusion within 24 hours before study
  • Chronic non-steroidal anti-inflammatory drug use (more than 6month daily use)
  • Rheumatoid arthritis

Outcomes

Primary Outcomes

Perioperative blood loss.

Time Frame: Before (baseline) the surgery and 24 hrs postoperatively

The volume loading test is deployed for the comparison of perioperative hemoglobin in the standardized plasma dilution.

Secondary Outcomes

  • Wound healing(Within 6 days postoperatively)
  • Hemodilution(Within 6 days postoperatively)
  • Cardiac stroke volume(Within 6 days postoperatively)
  • Body temperature(Within 6 days postoperatively)
  • Pain (Visual Analog Scale)(Within 6 days postoperatively)
  • Number of opiate injections(Within 6 days postoperatively)
  • Straight-leg raising test(Within 6 days postoperatively)
  • Timed up and go test(Within 6 days postoperatively)
  • Knee flexion, extension, extension lag(Within 6 days postoperatively)
  • Knee swelling(Within 6 days postoperatively)
  • Complications(Within 6 days postoperatively)

Study Sites (1)

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