Tourniquet study: Is the high thrombosis risk after knee arthroscopy caused by limb-tourniquet application? A randomized clinical trial into the effect of tourniquet use on the coagulation system.

Recruiting

• Conditions: blood clot in vein of the leg; Venous thrombosis; 10023213; 10014523

• Registration Number: NL-OMON40719
• Lead Sponsor: Groene Hart Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

Age of 18 years or older and arthroscopy of the knee for the following indications: Meniscectomy, diagnostic arthroscopy, removal of corpora libera

Exclusion Criteria

• Any kind of coagulation disorder
• pregnant or within 3 months of childbirth
• Use of hormonal anticonception
• A history of venous thrombosis
• Had major surgery in the past two monhts
• A history of cast-immobilization of the lower extremity the past two months
• A neoplasm or inflammatory disease
• A BMI>30
• using anticoagulant therapy
• Any other anaesthesia technique than spinal anaesthesia

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Data on duration of surgery and duration of tourniquet use will be collected.<br /><br>Blood collected from the cubital vein and the great saphenous vein during<br /><br>arthroscopy of the knee will be analyzed on outcome parameters that reflect a<br /><br>hypoxic state, an inflammatory reaction, involvement of the endothelium, a<br /><br>procoagulant state and thrombin formation.<br /><br><br /><br>Primary markers:<br /><br>• Prothrombin fragments 1 + 2<br /><br>• von Willebrand Factor (vWF)<br /><br>• D-dimer<br /><br>• P-selectin<br /><br>• Plasmin Activator Inhibitor 1 (PAI-1)<br /><br>• pH<br /><br>• pO2<br /><br>• pCO2<br /><br>• Lactate<br /><br>• White Blood Cell Count (WBCC)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• factor VIII<br /><br>• Thrombin and Antithrombin complexes (TAT)<br /><br>• Plasmin and antiplasmin complexes (PAP)<br /><br>• E-selectin<br /><br>• Tissue plasminogen activator (tPA)<br /><br>• Thrombomodulin<br /><br>• Neutrophil extracellular traps (NETs)</p><br>