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Completed

NCT Number: NCT01139658

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Boehringer Ingelheim Investigational Site 30, Angers, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Occurrence of Symptomatic Venous Thromboembolic Events

    Time frame: 11 weeks

    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).

  2. Occurrence of Major Bleeding Events

    Time frame: 11 weeks

    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 outcomes

  1. Dosage of Pradaxa at Initiation

    Time frame: Baseline

  2. Duration Between Surgery and First Dose of Pradaxa

    Time frame: 11 weeks

  3. Duration of Treatment

    Time frame: 11 weeks

  4. Proportion of Patients With a Preoperative ALT Measurement

    Time frame: 11 weeks

  5. Adherence to Treatment

    Time frame: 11 weeks

    The adherence to treatment was measured by patient declaration.

  6. Concomitant Treatments

    Time frame: 11 weeks

    Concomitant treatments prescribed at hospital discharge.

  7. Number of Patients Who Switched to Another Anticoagulant Therapy

    Time frame: 11 weeks

    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.

  8. Prescription for the Surveillance of the Platelet Count on the Day of Hospital Discharge

    Time frame: 11 weeks

  9. Prescription for Nursing Care and Nurse Visits on the Day of Hospital Discharge

    Time frame: 11 weeks

  10. Reasons for Nurse Visits on the Day of Hospital Discharge

    Time frame: 11 weeks

  11. Frequency of Nurse Visits on the Day of Hospital Discharge

    Time frame: 11 weeks

  12. Duration of Unplanned Hospitalizations at Visit 3

    Time frame: 11 weeks

  13. Reasons for Unplanned Hospitalizations at Visit 3

    Time frame: 11 weeks

  14. Reasons for Usual Follow-up

    Time frame: 11 weeks

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Observational Cohort Study on the Prevention of Venous Thromboembolic Events After Elective Orthopaedic Surgery in Patients Treated With PRADAXA

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jun 8, 2010
Registry last updated
Jan 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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