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

Observational Cohort Study to Evaluate Safety and Efficacy of Pradaxa (Dabigatran Etexilate) in Patients With Moderate Renal Impairment (Creatinine Clearance 30-50 ml/Min) Undergoing Elective Total Hip Replacement Surgery or Total Knee Replacement Surgery

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00847301

Enrollment

472

Registered

2009-02-19

Start date

2009-04-30

Completion date

2014-07-31

Last updated

2015-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthroplasty, Replacement, Thromboembolism

Brief 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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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 \< 30 ml/min); elevated liver enzymes \> 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

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Patients With Major Bleeding Events (MBE)	From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa	Major bleeding events were defined according to the modified McMaster criteria, and were classified by the investigator as Major bleeding event or Any bleeding event. The criteria for MBE's were: fatal; clinically overt associated with loss of haemoglobin \>=20g/L in excess of what was expected; clinically overt leading to the transfusion of \>=2 units packed cells or whole blood in excess of what was expected; symptomatic retroperitoneal, intracranial, intraocular or intraspinal; requiring treatment cessation; leading to re-operation
Percentage of Patients With Symptomatic Venous Thromboembolic Events (sVTE) and All Cause Mortality	From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa	The co-primary efficacy variable sVTE was defined as the composite of documented symptomatic proximal and distal deep vein thrombosis (DVT) and documented symptomatic non-fatal pulmonary embolism (PE) and All Cause Mortality.

Secondary

Measure	Time frame	Description
Documented Symptomatic Proximal DVT, Documented Symptomatic Distal DVT, Documented Symptomatic Nonfatal Pulmonary Embolism and All-cause Mortality	From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa	Percentage of participant with documented symptomatic proximal DVT (deep vein thrombosis), documented symptomatic distal DVT, documented symptomatic nonfatal pulmonary embolism and all-cause mortality
Percentage of Patients With Major Extra-surgical Site Bleedings	From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa	Percentage of Patients With Major Extra-surgical Site Bleedings
Volume of Wound Drainage (Post-operative)	From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa	Volume of Wound Drainage after surgery

Countries

Austria, France, Germany, Italy, Spain, Sweden, United Kingdom

Participant flow

Recruitment details

There were 472 patients entered into the study, 428 were treated with moderate renal impairment. Treated patients with moderate renal impairment are presented.

Participants by arm

Arm	Count
All Patients All Patients treated with dabigatran etexilate (Pradaxa), planned dose: 75 mg at the day of surgery, from the day after surgery to last treatment day 150 mg once daily.	428
Total	428

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	35
Overall Study	Lost to Follow-up	1
Overall Study	No prescription after hospital discharge	1
Overall Study	Other reason not defined above	1
Overall Study	Switch to other anticoagulants	16

Baseline characteristics

Characteristic	All Patients
Age, Continuous	78.6 years STANDARD_DEVIATION 7.4
Sex: Female, Male Female	324 Participants
Sex: Female, Male Male	104 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	24 / 468
serious Total, serious adverse events	34 / 468

Outcome results

Primary

Percentage of Patients With Major Bleeding Events (MBE)

Major bleeding events were defined according to the modified McMaster criteria, and were classified by the investigator as Major bleeding event or Any bleeding event. The criteria for MBE's were: fatal; clinically overt associated with loss of haemoglobin \>=20g/L in excess of what was expected; clinically overt leading to the transfusion of \>=2 units packed cells or whole blood in excess of what was expected; symptomatic retroperitoneal, intracranial, intraocular or intraspinal; requiring treatment cessation; leading to re-operation