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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01139658
First received: June 7, 2010
Last updated: November 27, 2013
Last verified: November 2013
  Purpose

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


Condition
Venous Thromboembolism

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Cohort Study on the Prevention of Venous Thromboembolic Events After Elective Orthopaedic Surgery in Patients Treated With PRADAXA

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Occurrence of Symptomatic Venous Thromboembolic Events [ Time Frame: 11 weeks ] [ Designated as safety issue: Yes ]
    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 Events [ Time Frame: 11 weeks ] [ Designated as safety issue: Yes ]

    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).



Secondary Outcome Measures:
  • Dosage of Pradaxa at Initiation [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Duration Between Surgery and First Dose of Pradaxa [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
  • Duration of Treatment [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
  • Proportion of Patients With a Preoperative ALT Measurement [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
  • Adherence to Treatment [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
    The adherence to treatment was measured by patient declaration.

  • Concomitant Treatments [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
    Concomitant treatments prescribed at hospital discharge.

  • Number of Patients Who Switched to Another Anticoagulant Therapy [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
    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 Discharge [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
  • Prescription for Nursing Care and Nurse Visits on the Day of Hospital Discharge [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
  • Reasons for Nurse Visits on the Day of Hospital Discharge [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
  • Frequency of Nurse Visits on the Day of Hospital Discharge [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
  • Duration of Unplanned Hospitalizations at Visit 3 [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
  • Reasons for Unplanned Hospitalizations at Visit 3 [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
  • Reasons for Usual Follow-up [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]

Enrollment: 1676
Study Start Date: August 2010
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
All comers

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Demographic, medical and chirurgical characteristics

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01139658

  Show 53 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01139658     History of Changes
Other Study ID Numbers: 1160.102
Study First Received: June 7, 2010
Results First Received: September 6, 2013
Last Updated: November 27, 2013
Health Authority: France: Haute Autorite de Sante Transparency Commission

Additional relevant MeSH terms:
Thromboembolism
Embolism
Venous Thromboembolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis

ClinicalTrials.gov processed this record on August 28, 2014