Venous thromboembolism Circulatory System Venous thromboembolism
Conditions
Interventions
Patients with objectively documented VTE were treated according to standard protocols, while patients with a normal diagnostic workup were followed up clinically for three months
Current intervention
Sponsors
University Hospital of Padua (Italy)
Eligibility
Inclusion criteria
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
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy outcome was the combined incidence of symptomatic PE, symptomatic and asymptomatic proximal DVT and symptomatic isolated calf DVT in both groups. The primary safety end-point was the incidence of major and clinically relevant bleeding. Major bleedings included: 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 2. Disabling, retroperitoneal, or intracranial events 3. Bleedings requiring re-intervention 4. Haemarthrosis with a joint drainage of more than 450 millilitres of blood A clinically relevant bleed was defined as haemarthrosis with a joint drainage of more than 100 and up to 450 millilitres of blood. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Overall incidence of proximal and distal DVT and symptomatic PE 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) 3. Incidence of superficial thrombophlebitis | — |
Countries
Italy
Outcome results
None listed