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.

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. - Tourniquet study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON40719

Enrollment

Registered

2015-04-07

Start date

2015-09-02

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

blood clot in vein of the leg Venous thrombosis

Interventions

Patients will be randomized to knee arthroscopy without tourniquet use and to knee arthroscopy with tourniquet use. In patients randomized to arthroscopy with tourniquet use, exsanguination in the l

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

Measure	Time frame
• factor VIII • Thrombin and Antithrombin complexes (TAT) • Plasmin and antiplasmin complexes (PAP) • E-selectin • Tissue plasminogen activator (tPA) • Thrombomodulin • Neutrophil extracellular traps (NETs)	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)