Arthroplasty, ReplacementNCT00847301

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

An observational study of Arthroplasty, Replacement and Thromboembolism, run by Boehringer Ingelheim at 53 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Arthroplasty, Replacement, Thromboembolism
How many people: 472 participants
Where: 53 sitesin 7 countries
Study dates: Apr 2009to Jul 2014
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Moderate renal insufficiency

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

53 sites in 7 countries.

Country

City, postcode or hospital

53 sites in 7 countries

France20 sites

1160.84.3311 Boehringer Ingelheim Investigational Site
Angers
1160.84.3334 Boehringer Ingelheim Investigational Site
Bordeaux
1160.84.3303 Boehringer Ingelheim Investigational Site
Caen
1160.84.3314 Boehringer Ingelheim Investigational Site
Clermont-Ferrand
1160.84.3320 Boehringer Ingelheim Investigational Site
Créteil
1160.84.3307 Boehringer Ingelheim Investigational Site
Dijon Cédex
1160.84.3310 Boehringer Ingelheim Investigational Site
Illkirch-Graffenstaden
1160.84.3335 Boehringer Ingelheim Investigational Site
Le Havre
1160.84.3326 Boehringer Ingelheim Investigational Site
Les Lilas
1160.84.3312 Boehringer Ingelheim Investigational Site
Lyon
1160.84.3305 Boehringer Ingelheim Investigational Site
Marseille
1160.84.3323 Boehringer Ingelheim Investigational Site
Nantes Cédex 2
1160.84.3302 Boehringer Ingelheim Investigational Site
Paris
1160.84.3306 Boehringer Ingelheim Investigational Site
Paris
1160.84.3313 Boehringer Ingelheim Investigational Site
Pierre-Bénite
1160.84.3324 Boehringer Ingelheim Investigational Site
Poitiers Cédex
1160.84.3322 Boehringer Ingelheim Investigational Site
Saint Etienne Cédex 2
1160.84.3319 Boehringer Ingelheim Investigational Site
Saint-Saulve
1160.84.3316 Boehringer Ingelheim Investigational Site
Toulouse Cédex 9
1160.84.3332 Boehringer Ingelheim Investigational Site
Vannes Cédex

Other trials in France

Germany11 sites

1160.84.04903 Boehringer Ingelheim Investigational Site
Berlin
1160.84.04947 Boehringer Ingelheim Investigational Site
Erlangen
1160.84.4922 Boehringer Ingelheim Investigational Site
Gelnhausen
1160.84.04927 Boehringer Ingelheim Investigational Site
Hachenburg
1160.84.04929 Boehringer Ingelheim Investigational Site
Koblenz
1160.84.04902 Boehringer Ingelheim Investigational Site
Marburg
1160.84.04946 Boehringer Ingelheim Investigational Site
München
1160.84.04913 Boehringer Ingelheim Investigational Site
Olsberg
1160.84.04914 Boehringer Ingelheim Investigational Site
Sylt
1160.84.04938 Boehringer Ingelheim Investigational Site
Wismar
1160.84.04948 Boehringer Ingelheim Investigational Site
Würzburg

Other trials in Germany

Spain8 sites

1160.84.3409 Boehringer Ingelheim Investigational Site
Badalona (Barcelona)
1160.84.3410 Boehringer Ingelheim Investigational Site
Barcelona
1160.84.3403 Boehringer Ingelheim Investigational Site
Madrid
1160.84.3405 Boehringer Ingelheim Investigational Site
Málaga
1160.84.3404 Boehringer Ingelheim Investigational Site
Pamplona
1160.84.3412 Boehringer Ingelheim Investigational Site
Pozuelo de Alarcón - Madrid
1160.84.3401 Boehringer Ingelheim Investigational Site
Valencia
1160.84.3402 Boehringer Ingelheim Investigational Site
Zaragoza

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United Kingdom5 sites

1160.84.04405 Boehringer Ingelheim Investigational Site
Basildon
1160.84.04408 Boehringer Ingelheim Investigational Site
Bedford
1160.84.04403 Boehringer Ingelheim Investigational Site
Luton
1160.84.04401 Boehringer Ingelheim Investigational Site
Wigan
1160.84.04407 Boehringer Ingelheim Investigational Site
Yeovil

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Italy4 sites

1160.84.03908 Boehringer Ingelheim Investigational Site
Latina
1160.84.03902 Boehringer Ingelheim Investigational Site
Milan
1160.84.03904 Boehringer Ingelheim Investigational Site
Monza
1160.84.03909 Boehringer Ingelheim Investigational Site
Udine

Other trials in Italy

Sweden3 sites

1160.84.4603 Boehringer Ingelheim Investigational Site
Kungälv
1160.84.4601 Boehringer Ingelheim Investigational Site
Motala
1160.84.4604 Boehringer Ingelheim Investigational Site
Sollefteå

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Austria2 sites

1160.84.4301 Boehringer Ingelheim Investigational Site
Vienna
1160.84.4310 Boehringer Ingelheim Investigational Site
Vienna

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About this study

Official title: 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

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

Conditions: Arthroplasty, Replacement, Thromboembolism
Medical subject headings: Thromboembolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00847301
Study group	Role	What they receive
Renal Impairment		Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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 Symptomatic Venous Thromboembolic Events (sVTE) and All Cause Mortality
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.
Measured: 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

Secondary outcomes (3)

Documented Symptomatic Proximal DVT, Documented Symptomatic Distal DVT, Documented Symptomatic Nonfatal Pulmonary Embolism and All-cause Mortality
Percentage of participant with documented symptomatic proximal DVT (deep vein thrombosis), documented symptomatic distal DVT, documented symptomatic nonfatal pulmonary embolism and all-cause mortality
Measured: 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
Percentage of Patients With Major Extra-surgical Site Bleedings
Measured: 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 (Post-operative)
Volume of Wound Drainage after surgery
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2009Jul 2014

First posted19 Feb 2009 (estimated)
Study startApr 2009
Primary completionJul 2014
Study completionJul 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Arthroplasty, ReplacementStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 472 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00847301
Sponsor's protocol ID: 1160.84
Status last verified: Aug 2015
First submitted: 18 Feb 2009
Last updated: 25 Sep 2015
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Comparison of Functional Results of ADM X3-MoP Cup (Stryker) and a CoC Cup (Zimmer) in Young Patients
Arthroplasties, Hip Replacement
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At Home, Digital Rehabilitation for Patients After Reverse Total Shoulder Arthroplasty
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Enrolling by invitationObservational study
Persona SoluTion PPS Femur PMCF
Rhematoid Arthritis, Osteo Arthritis of the Knee
Not yet recruiting
Negative Pressure Wound Therapy Devices in Total Knee Arthroplasty
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Active, not recruiting
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All Arthroplasty, Replacement trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT00847301
Acronym / sponsor ID: 1160.84
Conditions: Arthroplasty, Replacement, Thromboembolism
Study type: Observational
Recruitment status: Completed
Enrolment: 472 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Apr 2009
Primary completion: Jul 2014 (actual)
Study completion: Jul 2014 (actual)
First posted: 19 Feb 2009 (estimated)
Results: Posted 25 Sep 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Renal Impairment	–	–

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Moderate renal insufficiency

Key inclusion criteria (1 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Percentage of Patients With Major Bleeding Events (MBE)
Time frame: 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
Time frame: 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.

3 secondary outcomes

Documented Symptomatic Proximal DVT, Documented Symptomatic Distal DVT, Documented Symptomatic Nonfatal Pulmonary Embolism and All-cause Mortality
Time frame: 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
Time frame: 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 (Post-operative)
Time frame: 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

Results and safety

Results posted to the registry on 25 Sep 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Overall Study Design	428	374

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

Time frame: 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. Number (95% Confidence Interval). Unit: percentage of participants

Measure	All Patients n = 428
Value	2.10 (0.97 to 3.95)

Population analysed: Treated set with moderate renal impairment: this patient set included all patients with CrCl 30 - 50 mL/min who received at least one 1 of dabigatran etexilate.

Primary outcome: Percentage of Patients With Symptomatic Venous Thromboembolic Events (sVTE) and All Cause Mortality

Measure	All Patients n = 428
Value	0.70 (0.14 to 2.03)

Population analysed: Treated set with moderate renal impairment: this patient set included all patients with CrCl 30 - 50 mL/min who received at least one 1 of dabigatran etexilate.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first drug intake up to 24 h after last drug intake; planned number of days after surgery: knee replacement: 10 days, hip replacement: 28-35 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Patients	34 of 468 (7.3%)	24 of 468 (5.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Arthroplasty, Replacement

Enrolling by invitation
Comparison of Functional Results of ADM X3-MoP Cup (Stryker) and a CoC Cup (Zimmer) in Young Patients
Arthroplasties, Hip Replacement
Active, not recruiting
At Home, Digital Rehabilitation for Patients After Reverse Total Shoulder Arthroplasty
Arthroplasty, Replacement, Shoulder, Reverse Total Shoulder Arthroplasty
Enrolling by invitationObservational study
Persona SoluTion PPS Femur PMCF
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Not yet recruiting
Negative Pressure Wound Therapy Devices in Total Knee Arthroplasty
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Active, not recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

53 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Arthroplasty, Replacement and Thromboembolism, run by Boehringer Ingelheim at 53 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in France, Germany, Spain, United Kingdom, Italy and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Patients With Major Bleeding Events (MBE) (time frame: 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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00847301.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2015.