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Prevention of Venous Thromboembolic Events After Elective Orthopaedic Surgery in Patients Treated With PRADAXA

Completed
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
Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Occurrence of Symptomatic Venous Thromboembolic Events11 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 Events11 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 β‰₯ 2 g/dL or requiring transfusion β‰₯ 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
NameTimeMethod
Concomitant Treatments11 weeks

Concomitant treatments prescribed at hospital discharge.

Reasons for Nurse Visits on the Day of Hospital Discharge11 weeks
Proportion of Patients With a Preoperative ALT Measurement11 weeks
Adherence to Treatment11 weeks

The adherence to treatment was measured by patient declaration.

Duration of Treatment11 weeks
Prescription for Nursing Care and Nurse Visits on the Day of Hospital Discharge11 weeks
Frequency of Nurse Visits on the Day of Hospital Discharge11 weeks
Duration of Unplanned Hospitalizations at Visit 311 weeks
Dosage of Pradaxa at InitiationBaseline
Duration Between Surgery and First Dose of Pradaxa11 weeks
Number of Patients Who Switched to Another Anticoagulant Therapy11 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 Discharge11 weeks
Reasons for Unplanned Hospitalizations at Visit 311 weeks
Reasons for Usual Follow-up11 weeks

Trial Locations

Locations (53)

Boehringer Ingelheim Investigational Site 19

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Lyon, France

Boehringer Ingelheim Investigational Site 30

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Angers, France

Boehringer Ingelheim Investigational Site 40

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Beauvais, France

Boehringer Ingelheim Investigational Site 23

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La Roche sur Yon, France

Boehringer Ingelheim Investigational Site 12

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Macon, France

Boehringer Ingelheim Investigational Site 41

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Arles, France

Boehringer Ingelheim Investigational Site 15

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Reims, France

Boehringer Ingelheim Investigational Site 1

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Strasbourg, France

Boehringer Ingelheim Investigational Site 45

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Boulogne sur Mer, France

Boehringer Ingelheim Investigational Site 42

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Cahors, France

Boehringer Ingelheim Investigational Site 10

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Chateaubriant, France

Boehringer Ingelheim Investigational Site 36

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Chantilly, France

Boehringer Ingelheim Investigational Site 6

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Paris, France

Boehringer Ingelheim Investigational Site 18

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St Priest en Jarez, France

Boehringer Ingelheim Investigational Site 38

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Toulouse, France

Boehringer Ingelheim Investigational Site 2

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Berck sur Mer, France

Boehringer Ingelheim Investigational Site 25

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Bordeaux, France

Boehringer Ingelheim Investigational Site 13

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Bruay la Buissiere, France

Boehringer Ingelheim Investigational Site 50

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Castelnau le Lez, France

Boehringer Ingelheim Investigational Site 35

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Chateaubernard, France

Boehringer Ingelheim Investigational Site 9

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Clinique des Maussins-Paris, France

Boehringer Ingelheim Investigational Site 44

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Dole, France

Boehringer Ingelheim Investigational Site 27

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Le Blanc Menil, France

Boehringer Ingelheim Investigational Site 3

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Dracy le Fort, France

Boehringer Ingelheim Investigational Site 46

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Haguenau, France

Boehringer Ingelheim Investigational Site 33

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Illkirch-Graffenstaden, France

Boehringer Ingelheim Investigational Site 22

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Lannion, France

Boehringer Ingelheim Investigational Site 31

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Le Port Marly, France

Boehringer Ingelheim Investigational Site 5

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Lille, France

Boehringer Ingelheim Investigational Site 21

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Libourne, France

Boehringer Ingelheim Investigational Site 26

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Morlaix, France

Boehringer Ingelheim Investigational Site 47

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Marcq en Bareuil, France

Boehringer Ingelheim Investigational Site 28

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Merignac, France

Boehringer Ingelheim Investigational Site 48

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Nancy, France

Boehringer Ingelheim Investigational Site 7

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Nancy, France

Boehringer Ingelheim Investigational Site 11

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Paris, France

Boehringer Ingelheim Investigational Site 8

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Nice, France

Boehringer Ingelheim Investigational Site 17

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Paris, France

Boehringer Ingelheim Investigational Site 24

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Perpignan, France

Boehringer Ingelheim Investigational Site 14

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Poissy, France

Boehringer Ingelheim Investigational Site 49

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Ploemeur, France

Boehringer Ingelheim Investigational Site 39

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Pontarlier, France

Boehringer Ingelheim Investigational Site 43

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Pringy, France

Boehringer Ingelheim Investigational Site 20

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Rennes, France

Boehringer Ingelheim Investigational Site 4

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Saint GrΓ©goire, France

Boehringer Ingelheim Investigational Site 37

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Saumur, France

Boehringer Ingelheim Investigational Site 52

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St Georges de Didonne, France

Boehringer Ingelheim Investigational Site 34

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Semur en Auxois, France

Boehringer Ingelheim Investigational Site 53

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St Colombe les Viennes, France

Boehringer Ingelheim Investigational Site 32

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St Priest en Jarez, France

Boehringer Ingelheim Investigational Site 51

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St Saulve, France

Boehringer Ingelheim Investigational Site 29

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Tourcoing, France

Boehringer Ingelheim Investigational Site 16

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Villeneuve sur Lot, France

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