Venous Thromboembolism Clinical Trial
Official title:
Observational Cohort Study on the Prevention of Venous Thromboembolic Events After Elective Orthopaedic Surgery in Patients Treated With PRADAXA
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
Status | Completed |
Enrollment | 1676 |
Est. completion date | September 2012 |
Est. primary completion date | September 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion criteria: 1. Patients treated with Pradaxa undergoing surgery for Total Knee Replacement or Total Hip Replacement 2. Patients 18 years of age or older at the time of recruitment Exclusion criteria: 1. Patients presenting contraindication to prescription of Pradaxa 2. Patients in whom long term Anti vitamin K treatment is indicated |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
France | 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 | Boehringer Ingelheim Investigational Site 35 | Chateaubernard | |
France | Boehringer Ingelheim Investigational Site 10 | Chateaubriant | |
France | Boehringer Ingelheim Investigational Site 9 | Clinique des Maussins-Paris | |
France | Boehringer Ingelheim Investigational Site 44 | Dole | |
France | Boehringer Ingelheim Investigational Site 3 | Dracy le Fort | |
France | Boehringer Ingelheim Investigational Site 46 | Haguenau | |
France | Boehringer Ingelheim Investigational Site 33 | Illkirch-Graffenstaden | |
France | Boehringer Ingelheim Investigational Site 23 | La Roche sur Yon | |
France | Boehringer Ingelheim Investigational Site 22 | Lannion | |
France | Boehringer Ingelheim Investigational Site 27 | Le Blanc Menil | |
France | Boehringer Ingelheim Investigational Site 31 | Le Port Marly | |
France | Boehringer Ingelheim Investigational Site 21 | Libourne | |
France | Boehringer Ingelheim Investigational Site 5 | Lille | |
France | Boehringer Ingelheim Investigational Site 19 | Lyon | |
France | Boehringer Ingelheim Investigational Site 12 | Macon | |
France | Boehringer Ingelheim Investigational Site 47 | Marcq en Bareuil | |
France | Boehringer Ingelheim Investigational Site 28 | Merignac | |
France | Boehringer Ingelheim Investigational Site 26 | Morlaix | |
France | Boehringer Ingelheim Investigational Site 48 | Nancy | |
France | Boehringer Ingelheim Investigational Site 7 | Nancy | |
France | Boehringer Ingelheim Investigational Site 8 | Nice | |
France | Boehringer Ingelheim Investigational Site 11 | Paris | |
France | Boehringer Ingelheim Investigational Site 17 | Paris | |
France | Boehringer Ingelheim Investigational Site 6 | Paris | |
France | Boehringer Ingelheim Investigational Site 24 | Perpignan | |
France | Boehringer Ingelheim Investigational Site 49 | Ploemeur | |
France | Boehringer Ingelheim Investigational Site 14 | Poissy | |
France | Boehringer Ingelheim Investigational Site 39 | Pontarlier | |
France | Boehringer Ingelheim Investigational Site 43 | Pringy | |
France | Boehringer Ingelheim Investigational Site 15 | Reims | |
France | Boehringer Ingelheim Investigational Site 20 | Rennes | |
France | Boehringer Ingelheim Investigational Site 4 | Saint Grégoire | |
France | Boehringer Ingelheim Investigational Site 37 | Saumur | |
France | Boehringer Ingelheim Investigational Site 34 | Semur en Auxois | |
France | Boehringer Ingelheim Investigational Site 53 | St Colombe les Viennes | |
France | Boehringer Ingelheim Investigational Site 52 | St Georges de Didonne | |
France | Boehringer Ingelheim Investigational Site 18 | St Priest en Jarez | |
France | Boehringer Ingelheim Investigational Site 32 | St Priest en Jarez | |
France | Boehringer Ingelheim Investigational Site 51 | St Saulve | |
France | Boehringer Ingelheim Investigational Site 1 | Strasbourg | |
France | Boehringer Ingelheim Investigational Site 38 | Toulouse | |
France | Boehringer Ingelheim Investigational Site 29 | Tourcoing | |
France | Boehringer Ingelheim Investigational Site 16 | Villeneuve sur Lot |
Lead Sponsor | Collaborator |
---|---|
Boehringer Ingelheim |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Occurrence of Symptomatic Venous Thromboembolic Events | 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). | 11 weeks | Yes |
Primary | Occurrence of Major Bleeding Events | 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). |
11 weeks | Yes |
Secondary | Dosage of Pradaxa at Initiation | Baseline | No | |
Secondary | Duration Between Surgery and First Dose of Pradaxa | 11 weeks | No | |
Secondary | Duration of Treatment | 11 weeks | No | |
Secondary | Proportion of Patients With a Preoperative ALT Measurement | 11 weeks | No | |
Secondary | Adherence to Treatment | The adherence to treatment was measured by patient declaration. | 11 weeks | No |
Secondary | Concomitant Treatments | Concomitant treatments prescribed at hospital discharge. | 11 weeks | No |
Secondary | Number of Patients Who Switched to Another Anticoagulant Therapy | 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. | 11 weeks | No |
Secondary | Prescription for the Surveillance of the Platelet Count on the Day of Hospital Discharge | 11 weeks | No | |
Secondary | Prescription for Nursing Care and Nurse Visits on the Day of Hospital Discharge | 11 weeks | No | |
Secondary | Reasons for Nurse Visits on the Day of Hospital Discharge | 11 weeks | No | |
Secondary | Frequency of Nurse Visits on the Day of Hospital Discharge | 11 weeks | No | |
Secondary | Duration of Unplanned Hospitalizations at Visit 3 | 11 weeks | No | |
Secondary | Reasons for Unplanned Hospitalizations at Visit 3 | 11 weeks | No | |
Secondary | Reasons for Usual Follow-up | 11 weeks | No |
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