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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01139658
Other study ID # 1160.102
Secondary ID
Status Completed
Phase N/A
First received June 7, 2010
Last updated November 27, 2013
Start date August 2010
Est. completion date September 2012

Study information

Verified date November 2013
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority France: Haute Autorite de Sante Transparency Commission
Study type Observational

Clinical Trial 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


Recruitment information / eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

France, 

Outcome

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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