Graduated compression stockings versus low-molecular-weight heparin for prevention of venous thromboembolism after knee arthroscopy: a prospective randomised trial

Completed

Conditions: Venous thromboembolism
Circulatory System

Registration Number: ISRCTN75056741

Lead Sponsor: niversity Hospital of Padua (Italy)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 1300

Inclusion Criteria

All consecutive outpatients scheduled for diagnostic arthroscopy or arthroscopy-assisted knee surgery for anterior cruciate ligament reconstruction, partial lateral and/or medial meniscectomy, cartilage shaving or resurfacing, chondroplasty, combined surgical procedures and other surgical procedures (e.g. loose body removal, patella realignment, etc.)

Exclusion Criteria

1. Aged less than 18 years
2. Pregnancy
3. Previous deep vein thrombosis (DVT) and/or pulmonary embolism (PE)
4. Active malignancy
5. Known thrombophilia
6. Mandatory anticoagulation
7. Hypersensitivity to low-molecular weight heparins
8. History of recent major bleeding, as described below (less than 4 weeks)
9. Severe renal or hepatic failure
10. Anticipated poor compliance with the study requirements
11. Geographic inaccessibility

Owing to the recommendations of latest ACCP conference, 17 patients with complicated procedures and a tourniquet thigh time longer than 60 minutes were excluded, because they were considered, hypothetically, at higher risk of developing venous thromboembolic complications and pharmacological thromboprophylaxis with fixed-dose of low-molecular weight heparins is suggested (grade 2B).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary efficacy outcome was the combined incidence of symptomatic PE, symptomatic and asymptomatic proximal DVT and symptomatic isolated calf DVT in both groups.<br><br>The primary safety end-point was the incidence of major and clinically relevant bleeding. Major bleedings included: <br>1. Clinically overt haemorrhages associated with a drop in haemoglobin of at least 20 g/L or with the transfusion of two or more units of packed cells<br>2. Disabling, retroperitoneal, or intracranial events<br>3. Bleedings requiring re-intervention<br>4. Haemarthrosis with a joint drainage of more than 450 millilitres of blood<br><br>A clinically relevant bleed was defined as haemarthrosis with a joint drainage of more than 100 and up to 450 millilitres of blood.

Secondary Outcome Measures

Name	Time	Method
1. Overall incidence of proximal and distal DVT and symptomatic PE<br>2. Overall incidence of bleeding, including minor episodes (defined as haemarthrosis with a joint drainage of less than 100 millilitres of blood, and all other non-major and non-clinically relevant bleedings)<br>3. Incidence of superficial thrombophlebitis