N/A
N=1,676
Prevention of Venous Thromboembolic Events After Elective Orthopaedic Surgery in Patients Treated With PRADAXA
Venous Thromboembolism
Bottom Line
View on ClinicalTrials.gov: NCT01139658 ↗Enrolled (actual)
1,676
Serious AEs
5.1%
Results posted
Jan 2014
Primary outcome: Primary: Occurrence of Symptomatic Venous Thromboembolic Events — 19; 5 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Sep 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Occurrence of Symptomatic Venous Thromboembolic Events |
19; 5 | — |
| PRIMARY Occurrence of Major Bleeding Events |
8; 16 | — |
| SECONDARY Dosage of Pradaxa at Initiation |
142; 162; 394; 417; 80; 122 | — |
| SECONDARY Duration Between Surgery and First Dose of Pradaxa |
12.6; 14.6 | — |
| SECONDARY Duration of Treatment |
27.5; 33.3 | — |
| SECONDARY Proportion of Patients With a Preoperative ALT Measurement |
73.3; 74.5 | — |
| SECONDARY Adherence to Treatment |
98.6; 97.3 | — |
| SECONDARY Concomitant Treatments |
150; 143; 79; 61; 9; 8 | — |
| SECONDARY Number of Patients Who Switched to Another Anticoagulant Therapy |
43; 45 | — |
| SECONDARY Prescription for the Surveillance of the Platelet Count on the Day of Hospital Discharge |
24; 44 | — |
| SECONDARY Prescription for Nursing Care and Nurse Visits on the Day of Hospital Discharge |
420; 584 | — |
| SECONDARY Reasons for Nurse Visits on the Day of Hospital Discharge |
366; 510; 27; 69; 29; 54 | — |
| SECONDARY Frequency of Nurse Visits on the Day of Hospital Discharge |
2.3; 2.5; 1.7; 1.7 | — |
| SECONDARY Duration of Unplanned Hospitalizations at Visit 3 |
— | — |
| SECONDARY Reasons for Unplanned Hospitalizations at Visit 3 |
— | — |
| SECONDARY Reasons for Usual Follow-up |
11; 17; 201; 292; 19; 28 | — |
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
- 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
Data sourced from ClinicalTrials.gov (NCT01139658). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.