N/A N=5,292

Pradaxa (Dabigatran Etexilate 220 mg/q.d. in the General Population After Hip or Knee Replacement Surgery

Arthroplasty, Replacement · Thromboembolism

Bottom Line

View on ClinicalTrials.gov: NCT00846807 ↗

Enrolled (actual)

5,292

Serious AEs

2.6%

Results posted

Aug 2012

Primary outcome: Primary: Percentage of Patients With Major Bleeding Events (MBE) During Treatment Period — 0.72 Percentage of participants

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: —
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Boehringer Ingelheim
Primary completion: Jul 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Patients With Major Bleeding Events (MBE) During Treatment Period	0.72	—
PRIMARY Percentage of Patients With Symptomatic Venous Thromboembolic Events (sVTE) and All Cause Mortality	1.04	—
SECONDARY Percentage of Patients With Major Extra-surgical Site Bleedings	0.32	—
SECONDARY Volume of Wound Drainage (Post-operative)	704.5	—
SECONDARY Percentage of Patients With Single Components of Composite of sVTE and All-cause Mortality	0.17; 0.87; 0.09; 0.06	—

Summary

An observational cohort study on safety and efficacy of the 220 mg dose Pradaxa to generate additional data in predefined sub populations of patients at increased risk of bleeding or VTE

Eligibility Criteria

Inclusion criteria

Patients of 18 years of age or above undergoing elective total hip or knee replacement surgery who consent in writing to their participation in this observational study

Exclusion criteria

All patients who should not be treated with Pradaxa 220 mg according to the European Summary of Product Characteristics (SPC): age of > 75 years, renal impairment (creatinine clearance 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

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Data sourced from ClinicalTrials.gov (NCT00846807). 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.