Anticoagulant treatment after knee arthroscopy or during plaster cast lower leg immobilisation: determining the balance between benefits and risks

Recruiting

Conditions: blood cloth in vein of the leg
Venous Thrombosis
10005942
10017322
10014523

Registration Number: NL-OMON41615

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 3000

Inclusion Criteria

Arthroscopy of the knee
Lower leg plaster cast immobilisation.

Exclusion Criteria

Contra-indications for LMWH use (recent major bleeding, bleeding disorder, allergy)
Pregnancy
Pre-existent indication for anticoagulation therapy, either LMWH or vitamin K antagonists.
Mental of physical disability to fulfil study requirements.
Insufficient knowledge of the Dutch language.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary efficacy outcome is symptomatic venous thrombosis, i.e., deep<br /><br>venous thrombosis (DVT) or fatal or non-fatal pulmonary embolism (PE).<br /><br>The primary safety outcome is major bleeding, defined according to the<br /><br>guidelines of the ISTH:<br /><br>a) fatal bleeding or<br /><br>b) symptomatic bleeding in a critical area or organ, or<br /><br>c) extrasurgical site bleeding causing a fall in hemoglobin level of 1.24<br /><br>mmol/L or more, or leading to transfusion of one or more units of whole blood<br /><br>or red cells, or<br /><br>d) surgical site bleeding that requires a second intervention or a hemarthros<br /><br>interfering with rehabilitation, or surgical site bleeding for which<br /><br>bloodtransfusion is indicated</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Other clinically relevant bleeding, defined as overt bleeding not meeting the<br /><br>criteria for major bleeding but associated with medical intervention,<br /><br>unscheduled contact with a physician, (temporary) cessation of study treatment,<br /><br>or associated with discomfort such as pain, or impairment of activities of<br /><br>daily life.<br /><br><br /><br>Economic evaluation: Cost-effectiveness analysis (costs per prevented venous<br /><br>thrombosis and/or pulmonary embolism) and model-based cost-utiltity analysis<br /><br>from a societal perspective (costs per QALY)<br /><br><br /><br>Risk factor analysis:<br /><br>- Genetic variants: rs6025 (F5, Factor V Leiden), rs1799963 (F2, 20210 G>A),<br /><br>ABO blood Group, rs2066865 (FGG 10034 C>T), rs2289252 (F11)<br /><br>- Plasma levels: factor VIII, factorIX, prothrombin, fibrinogen, Protein C,<br /><br>Protein S, antithrombin.<br /><br>-Acquired risk factors (cancer, hormone use, etc)</p><br>