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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01139658
• Other study ID #: 1160.102
• 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

• Thromboembolism
• Venous Thromboembolism

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