Prevention of Venous Thromboembolic Events After Elective Orthopaedic Surgery in Patients Treated With PRADAXA
- Conditions
- Venous Thromboembolism
- Registration Number
- NCT01139658
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Observational cohort study on the prevention of venous thromboembolic events after elective orthopaedic surgery for Total Knee Replacement or Total Hip Replacement iin patients treated with PRADAXA to evaluate the efficacy ant safety of Pradaxa in real-life conditions
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1676
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Occurrence of Symptomatic Venous Thromboembolic Events 11 weeks Occurrence of symptomatic venous thromboembolic (VTE) events in patients treated with Pradaxa (dabigatran etexilate) after orthopaedic surgery (either Total Hip Replacement (THR) or Total Knee Replacement surgery (TKR)). Symptomatic VTE events were defined as a confirmed proximal or distal deep vein thrombosis (DVT) or a confirmed pulmonary embolism (PE).
Occurrence of Major Bleeding Events 11 weeks Occurrence of major bleeding events (MBEs) in patients treated with Pradaxa (dabigatran etexilate) after orthopaedic surgery (either THR or TKR surgery). MBEs were defined as any fatal haemorrhage, any overt bleeding greater than could be expected combined with a loss of haemoglobin ≥ 2 g/dL or requiring transfusion ≥ 2 packed red blood cells units (PRBC), any symptomatic retroperitoneal, intracranial, intraocular or intraspinal haemorrhage or any bleeding requireing treatment cessation or reoperation.
a confirmed proximal or distal deep vein thrombosis (DVT) or a confirmed pulmonary emboliam (PE).
- Secondary Outcome Measures
Name Time Method Proportion of Patients With a Preoperative ALT Measurement 11 weeks Duration of Treatment 11 weeks Prescription for Nursing Care and Nurse Visits on the Day of Hospital Discharge 11 weeks Frequency of Nurse Visits on the Day of Hospital Discharge 11 weeks Duration of Unplanned Hospitalizations at Visit 3 11 weeks Dosage of Pradaxa at Initiation Baseline Adherence to Treatment 11 weeks The adherence to treatment was measured by patient declaration.
Concomitant Treatments 11 weeks Concomitant treatments prescribed at hospital discharge.
Reasons for Nurse Visits on the Day of Hospital Discharge 11 weeks Duration Between Surgery and First Dose of Pradaxa 11 weeks Number of Patients Who Switched to Another Anticoagulant Therapy 11 weeks Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.
Prescription for the Surveillance of the Platelet Count on the Day of Hospital Discharge 11 weeks Reasons for Unplanned Hospitalizations at Visit 3 11 weeks Reasons for Usual Follow-up 11 weeks
Trial Locations
- Locations (53)
Boehringer Ingelheim Investigational Site 30
🇫🇷Angers, France
Boehringer Ingelheim Investigational Site 41
🇫🇷Arles, France
Boehringer Ingelheim Investigational Site 40
🇫🇷Beauvais, France
Boehringer Ingelheim Investigational Site 2
🇫🇷Berck sur Mer, France
Boehringer Ingelheim Investigational Site 25
🇫🇷Bordeaux, France
Boehringer Ingelheim Investigational Site 45
🇫🇷Boulogne sur Mer, France
Boehringer Ingelheim Investigational Site 13
🇫🇷Bruay la Buissiere, France
Boehringer Ingelheim Investigational Site 42
🇫🇷Cahors, France
Boehringer Ingelheim Investigational Site 50
🇫🇷Castelnau le Lez, France
Boehringer Ingelheim Investigational Site 36
🇫🇷Chantilly, France
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