Clinical trial NCT01139658: Prevention of Venous Thromboembolic Events After Elective Orthopaedic Surgery in Patients Treated With PRADAXA
Official title: Observational Cohort Study on the Prevention of Venous Thromboembolic Events After Elective Orthopaedic Surgery in Patients Treated With PRADAXA
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Thromboembolism
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2010-06-08
Enrollment: 1676
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Demographic, medical and chirurgical characteristics

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


Eligibility criteria: 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

Primary outcomes:
measure: Occurrence of Symptomatic Venous Thromboembolic Events
timeFrame: 11 weeks
measure: Occurrence of Major Bleeding Events
timeFrame: 11 weeks
Secondary outcomes:
measure: Dosage of Pradaxa at Initiation
timeFrame: Baseline
measure: Duration Between Surgery and First Dose of Pradaxa
timeFrame: 11 weeks
measure: Duration of Treatment
timeFrame: 11 weeks
measure: Proportion of Patients With a Preoperative ALT Measurement
timeFrame: 11 weeks
measure: Adherence to Treatment
timeFrame: 11 weeks
measure: Concomitant Treatments
timeFrame: 11 weeks
measure: Number of Patients Who Switched to Another Anticoagulant Therapy
timeFrame: 11 weeks
measure: Prescription for the Surveillance of the Platelet Count on the Day of Hospital Discharge
timeFrame: 11 weeks
measure: Prescription for Nursing Care and Nurse Visits on the Day of Hospital Discharge
timeFrame: 11 weeks
measure: Reasons for Nurse Visits on the Day of Hospital Discharge
timeFrame: 11 weeks
measure: Frequency of Nurse Visits on the Day of Hospital Discharge
timeFrame: 11 weeks
measure: Duration of Unplanned Hospitalizations at Visit 3
timeFrame: 11 weeks
measure: Reasons for Unplanned Hospitalizations at Visit 3
timeFrame: 11 weeks
measure: Reasons for Usual Follow-up
timeFrame: 11 weeks
Other outcomes:
Locations:
city: Angers
country: France
facility: Boehringer Ingelheim Investigational Site 30
city: Arles
country: France
facility: Boehringer Ingelheim Investigational Site 41
city: Beauvais
country: France
facility: Boehringer Ingelheim Investigational Site 40
city: Berck sur Mer
country: France
facility: Boehringer Ingelheim Investigational Site 2
city: Bordeaux
country: France
facility: Boehringer Ingelheim Investigational Site 25
city: Boulogne sur Mer
country: France
facility: Boehringer Ingelheim Investigational Site 45
city: Bruay la Buissiere
country: France
facility: Boehringer Ingelheim Investigational Site 13
city: Cahors
country: France
facility: Boehringer Ingelheim Investigational Site 42
city: Castelnau le Lez
country: France
facility: Boehringer Ingelheim Investigational Site 50
city: Chantilly
country: France
facility: Boehringer Ingelheim Investigational Site 36
city: Chateaubernard
country: France
facility: Boehringer Ingelheim Investigational Site 35
city: Chateaubriant
country: France
facility: Boehringer Ingelheim Investigational Site 10
city: Clinique des Maussins-Paris
country: France
facility: Boehringer Ingelheim Investigational Site 9
city: Dole
country: France
facility: Boehringer Ingelheim Investigational Site 44
city: Dracy le Fort
country: France
facility: Boehringer Ingelheim Investigational Site 3
city: Haguenau
country: France
facility: Boehringer Ingelheim Investigational Site 46
city: Illkirch-Graffenstaden
country: France
facility: Boehringer Ingelheim Investigational Site 33
city: La Roche sur Yon
country: France
facility: Boehringer Ingelheim Investigational Site 23
city: Lannion
country: France
facility: Boehringer Ingelheim Investigational Site 22
city: Le Blanc Menil
country: France
facility: Boehringer Ingelheim Investigational Site 27
city: Le Port Marly
country: France
facility: Boehringer Ingelheim Investigational Site 31
city: Libourne
country: France
facility: Boehringer Ingelheim Investigational Site 21
city: Lille
country: France
facility: Boehringer Ingelheim Investigational Site 5
city: Lyon
country: France
facility: Boehringer Ingelheim Investigational Site 19
city: Macon
country: France
facility: Boehringer Ingelheim Investigational Site 12
city: Marcq en Bareuil
country: France
facility: Boehringer Ingelheim Investigational Site 47
city: Merignac
country: France
facility: Boehringer Ingelheim Investigational Site 28
city: Morlaix
country: France
facility: Boehringer Ingelheim Investigational Site 26
city: Nancy
country: France
facility: Boehringer Ingelheim Investigational Site 48
city: Nancy
country: France
facility: Boehringer Ingelheim Investigational Site 7
city: Nice
country: France
facility: Boehringer Ingelheim Investigational Site 8
city: Paris
country: France
facility: Boehringer Ingelheim Investigational Site 11
city: Paris
country: France
facility: Boehringer Ingelheim Investigational Site 17
city: Paris
country: France
facility: Boehringer Ingelheim Investigational Site 6
city: Perpignan
country: France
facility: Boehringer Ingelheim Investigational Site 24
city: Ploemeur
country: France
facility: Boehringer Ingelheim Investigational Site 49
city: Poissy
country: France
facility: Boehringer Ingelheim Investigational Site 14
city: Pontarlier
country: France
facility: Boehringer Ingelheim Investigational Site 39
city: Pringy
country: France
facility: Boehringer Ingelheim Investigational Site 43
city: Reims
country: France
facility: Boehringer Ingelheim Investigational Site 15
city: Rennes
country: France
facility: Boehringer Ingelheim Investigational Site 20
city: Saint Grégoire
country: France
facility: Boehringer Ingelheim Investigational Site 4
city: Saumur
country: France
facility: Boehringer Ingelheim Investigational Site 37
city: Semur en Auxois
country: France
facility: Boehringer Ingelheim Investigational Site 34
city: St Colombe les Viennes
country: France
facility: Boehringer Ingelheim Investigational Site 53
city: St Georges de Didonne
country: France
facility: Boehringer Ingelheim Investigational Site 52
city: St Priest en Jarez
country: France
facility: Boehringer Ingelheim Investigational Site 18
city: St Priest en Jarez
country: France
facility: Boehringer Ingelheim Investigational Site 32
city: St Saulve
country: France
facility: Boehringer Ingelheim Investigational Site 51
city: Strasbourg
country: France
facility: Boehringer Ingelheim Investigational Site 1
city: Toulouse
country: France
facility: Boehringer Ingelheim Investigational Site 38
city: Tourcoing
country: France
facility: Boehringer Ingelheim Investigational Site 29
city: Villeneuve sur Lot
country: France
facility: Boehringer Ingelheim Investigational Site 16
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: