N/A N=428

Pradaxa (Dabigatran Etexilate) 150 mg/q.d. in Patients With Moderate Renal Impairment After Hip or Knee Replacement Surgery

Arthroplasty, Replacement · Thromboembolism

Bottom Line

View on ClinicalTrials.gov: NCT00847301 ↗

Enrolled (actual)

428

Serious AEs

7.3%

Results posted

Sep 2015

Primary outcome: Primary: Percentage of Patients With Major Bleeding Events (MBE) — 2.10 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 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Patients With Major Bleeding Events (MBE)	2.10	—
PRIMARY Percentage of Patients With Symptomatic Venous Thromboembolic Events (sVTE) and All Cause Mortality	0.70	—
SECONDARY Documented Symptomatic Proximal DVT, Documented Symptomatic Distal DVT, Documented Symptomatic Nonfatal Pulmonary Embolism and All-cause Mortality	0.23; 0.0; 0.23; 0.23	—
SECONDARY Percentage of Patients With Major Extra-surgical Site Bleedings	1.87	—
SECONDARY Volume of Wound Drainage (Post-operative)	685.2	—

Summary

An observational cohort study on safety and efficacy to generate additional data on the benefit/risk profile of the 150 mg dose of Pradaxa in patients with renal impairment

Eligibility Criteria

Inclusion criteria

Patients of 18 years of age or above with moderate renal impairment (creatinine clearance 30-50 ml/min) undergoing elective total hip replacement surgery who consent in writing to their participation in this observational study

Exclusion criteria

All patients who should not be treated with Pradaxa 150 mg according to the European Summary of Product Characteristics (SPC):

severe renal impairment (creatinine clearance 2 upper limit of normal (ULN); 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, concomitant treatment with quinidine, protehetic heart valve requiring anticoagulant treatment

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Data sourced from ClinicalTrials.gov (NCT00847301). 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.