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

NCT01139658 | Completed Results

• 1 other identifier: 1160.102
• Study Type: observational
• Target: 1,676
• Locations: 1 country
• Sites: 53

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

Conditions

Venous Thromboembolism

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (14)

• Dosage of Pradaxa at Initiation

  Baseline

• Duration Between Surgery and First Dose of Pradaxa

  11 weeks

• Duration of Treatment

  11 weeks

• Proportion of Patients With a Preoperative ALT Measurement

  11 weeks

• Adherence to Treatment

  11 weeks

Study Arms (1)

All comers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Demographic, medical and chirurgical characteristics

You may qualify if:

• Patients treated with Pradaxa undergoing surgery for Total Knee Replacement or Total Hip Replacement
• Patients 18 years of age or older at the time of recruitment

You may not qualify if:

• Patients presenting contraindication to prescription of Pradaxa
• Patients in whom long term Anti vitamin K treatment is indicated

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (53)

Boehringer Ingelheim Investigational Site 30

Angers, France

Location

Boehringer Ingelheim Investigational Site 41

Arles, France

Location

Boehringer Ingelheim Investigational Site 40

Beauvais, France

Location

Boehringer Ingelheim Investigational Site 2

Berck, France

Location

Boehringer Ingelheim Investigational Site 25

Bordeaux, France

Location

Boehringer Ingelheim Investigational Site 45

Boulogne-sur-Mer, France

Location

Boehringer Ingelheim Investigational Site 13

Bruay-la-Buissière, France

Location

Boehringer Ingelheim Investigational Site 42

Cahors, France

Location

Boehringer Ingelheim Investigational Site 50

Castelnau-le-Lez, France

Location

Boehringer Ingelheim Investigational Site 36

Chantilly, France

Location

Boehringer Ingelheim Investigational Site 35

Châteaubernard, France

Location

Boehringer Ingelheim Investigational Site 10

Châteaubriant, France

Location

Boehringer Ingelheim Investigational Site 9

Clinique Des Maussins-Paris, France

Location

Boehringer Ingelheim Investigational Site 44

Dole, France

Location

Boehringer Ingelheim Investigational Site 3

Dracy-le-Fort, France

Location

Boehringer Ingelheim Investigational Site 46

Haguenau, France

Location

Boehringer Ingelheim Investigational Site 33

Illkirch-Graffenstaden, France

Location

Boehringer Ingelheim Investigational Site 23

La Roche-sur-Yon, France

Location

Boehringer Ingelheim Investigational Site 22

Lannion, France

Location

Boehringer Ingelheim Investigational Site 27

Le Blanc Menil, France

Location

Boehringer Ingelheim Investigational Site 31

Le Port-Marly, France

Location

Boehringer Ingelheim Investigational Site 21

Libourne, France

Location

Boehringer Ingelheim Investigational Site 5

Lille, France

Location

Boehringer Ingelheim Investigational Site 19

Lyon, France

Location

Boehringer Ingelheim Investigational Site 47

Marcq En Bareuil, France

Location

Boehringer Ingelheim Investigational Site 12

Mâcon, France

Location

Boehringer Ingelheim Investigational Site 28

Mérignac, France

Location

Boehringer Ingelheim Investigational Site 26

Morlaix, France

Location

Boehringer Ingelheim Investigational Site 48

Nancy, France

Location

Boehringer Ingelheim Investigational Site 7

Nancy, France

Location

Boehringer Ingelheim Investigational Site 8

Nice, France

Location

Boehringer Ingelheim Investigational Site 11

Paris, France

Location

Boehringer Ingelheim Investigational Site 17

Paris, France

Location

Boehringer Ingelheim Investigational Site 6

Paris, France

Location

Boehringer Ingelheim Investigational Site 24

Perpignan, France

Location

Boehringer Ingelheim Investigational Site 49

Ploemeur, France

Location

Boehringer Ingelheim Investigational Site 14

Poissy, France

Location

Boehringer Ingelheim Investigational Site 39

Pontarlier, France

Location

Boehringer Ingelheim Investigational Site 43

Pringy, France

Location

Boehringer Ingelheim Investigational Site 15

Reims, France

Location

Boehringer Ingelheim Investigational Site 20

Rennes, France

Location

Boehringer Ingelheim Investigational Site 53

Saint Colombe Les Viennes, France

Location

Boehringer Ingelheim Investigational Site 52

Saint-Georges-de-Didonne, France

Location

Boehringer Ingelheim Investigational Site 4

Saint-Grégoire, France

Location

Boehringer Ingelheim Investigational Site 18

Saint-Priest-en-Jarez, France

Location

Boehringer Ingelheim Investigational Site 32

Saint-Priest-en-Jarez, France

Location

Boehringer Ingelheim Investigational Site 51

Saint-Saulve, France

Location

Boehringer Ingelheim Investigational Site 37

Saumur, France

Location

Boehringer Ingelheim Investigational Site 34

Semur-en-Auxois, France

Location

Boehringer Ingelheim Investigational Site 1

Strasbourg, France

Location

Boehringer Ingelheim Investigational Site 38

Toulouse, France

Location

Boehringer Ingelheim Investigational Site 29

Tourcoing, France

Location

Boehringer Ingelheim Investigational Site 16

Villeneuve-sur-Lot, France

Location

MeSH Terms

Conditions

Venous Thromboembolism

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

Data for the following secondary endpoints were not collected: Medical appointments with a general practitioner or specialist at visit 3, Frequency of medical appointments at visit 3, Prescription received at visit 3.

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2010
• First Posted: June 8, 2010
• Study Start: August 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: January 16, 2014
• Results First Posted: January 16, 2014

Record last verified: 2013-11

Locations

FR (53)