Arthroplasty, Replacement, Hip, Thromboembolism
Conditions
Brief summary
Open, prospective, uncontrolled, observational cohort study.
Interventions
None listed
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
* patients age 18 years or above undergoing elective total hip or knee replacement surgery * Written informed consent obtained for data collection and source data verification.
Exclusion criteria
According to the approved label the following patients should not be treated with Pradaxar® 220mg q.d.: * age of \> 75 years * renal impairment (creatinine clearance \<50ml/min) * patients on concomitant therapy with amiodarone or verapamil. * elevated liver enzymes \>2 upper limit of normal (ULN) and / or hepatic impairment or liver disease expected to have any impact on survival * anaesthesia with post-operative indwelling epidural catheters * hypersensitivity to dabigatran etexilate or to any of the excipients * active clinically significant bleeding * organic lesion at risk of bleeding * spontaneous or pharmacological impairment of haemostasis except for the above-included patients groups * concomitant treatment with quinidine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Venous Thromboembolic Events | 6 Months |
Secondary
| Measure | Time frame |
|---|---|
| Major Bleeding Events (MBE) | From 12 To 37 Days |
| Major Extra Surgical Site Bleedings | From 12 To 37 Days |
| Volume of Wound Drainage | From 12 To 37 Days |
Countries
Mexico
Participant flow
Recruitment details
Only two patients were included into the study. The sponsor decided to finish it due to a delay of recruitment period.
Participants by arm
| Arm | Count |
|---|---|
| Dabigatran Exilate 220 Once Daily (OD) 10 days for Knee Replacement or 28-35 Hip Replacement | 0 |
| Total | 0 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
Primary
Venous Thromboembolic Events
Time frame: 6 Months
Population: The trial was stopped due poor enrollment
Secondary
Major Bleeding Events (MBE)
Time frame: From 12 To 37 Days
Population: The trial was stopped due poor enrollment
Secondary
Major Extra Surgical Site Bleedings
Time frame: From 12 To 37 Days
Population: The trial was stopped due poor enrollment
Secondary
Volume of Wound Drainage
Time frame: From 12 To 37 Days
Population: The trial was stopped due poor enrollment