Arthroplasty, ReplacementNCT00846807

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

An observational study of Arthroplasty, Replacement and Thromboembolism, run by Boehringer Ingelheim at 112 sites in 9 countries.

Completed

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

Official record

Search all trials

Trial 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 Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Arthroplasty, Replacement, Thromboembolism
How many people: 5,476 participants
Where: 112 sitesin 9 countries
Study dates: Feb 2009to Jul 2011
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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Subgroups of the general population

Who may be able to join

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

Who cannot join

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 <50 ml/min), patients with concomitant therapy of amiodarone, 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

Trial locations and contacts

112 sites in 9 countries.

Country

City, postcode or hospital

112 sites in 9 countries

Germany44 sites

1160.85.04924 Boehringer Ingelheim Investigational Site
Bad Homburg
1160.85.04926 Boehringer Ingelheim Investigational Site
Bayreuth
1160.85.04903 Boehringer Ingelheim Investigational Site
Berlin
1160.85.04931 Boehringer Ingelheim Investigational Site
Bochum
1160.85.04930 Boehringer Ingelheim Investigational Site
Breitenbrunn
1160.85.04923 Boehringer Ingelheim Investigational Site
Chemnitz
1160.85.04947 Boehringer Ingelheim Investigational Site
Erlangen
1160.85.04945 Boehringer Ingelheim Investigational Site
Fürth
1160.85.04912 Boehringer Ingelheim Investigational Site
Garmische-Partenkirchen
1160.85.04922 Boehringer Ingelheim Investigational Site
Gelnhausen
1160.85.04917 Boehringer Ingelheim Investigational Site
Gelsenkirchen
1160.85.04949 Boehringer Ingelheim Investigational Site
Günzburg
1160.85.04927 Boehringer Ingelheim Investigational Site
Hachenburg
1160.85.04910 Boehringer Ingelheim Investigational Site
Hamburg
1160.85.04906 Boehringer Ingelheim Investigational Site
Hanover
1160.85.04920 Boehringer Ingelheim Investigational Site
Hof
1160.85.04916 Boehringer Ingelheim Investigational Site
Kamp-Linfort
1160.85.04939 Boehringer Ingelheim Investigational Site
Kassel
1160.85.04929 Boehringer Ingelheim Investigational Site
Koblenz
1160.85.04909 Boehringer Ingelheim Investigational Site
Landstuhl
1160.85.04944 Boehringer Ingelheim Investigational Site
Lubin
1160.85.04935 Boehringer Ingelheim Investigational Site
Mainz
1160.85.04902 Boehringer Ingelheim Investigational Site
Marburg
1160.85.04934 Boehringer Ingelheim Investigational Site
Markgröningen
1160.85.04918 Boehringer Ingelheim Investigational Site
Marktheidenfeld
1160.85.04941 Boehringer Ingelheim Investigational Site
Merseburg
1160.85.04952 Boehringer Ingelheim Investigational Site
Minden
1160.85.04943 Boehringer Ingelheim Investigational Site
München
1160.85.04946 Boehringer Ingelheim Investigational Site
München
1160.85.04904 Boehringer Ingelheim Investigational Site
Nuremberg
1160.85.04913 Boehringer Ingelheim Investigational Site
Olsberg
1160.85.04932 Boehringer Ingelheim Investigational Site
Pfortzheim
1160.85.04901 Boehringer Ingelheim Investigational Site
Rosenheim
1160.85.04915 Boehringer Ingelheim Investigational Site
Rostock
1160.85.04928 Boehringer Ingelheim Investigational Site
Rostock
1160.85.04936 Boehringer Ingelheim Investigational Site
Rotenburg/Fulda
1160.85.04905 Boehringer Ingelheim Investigational Site
Schwarzenbruck
1160.85.04914 Boehringer Ingelheim Investigational Site
Sylt
1160.85.04933 Boehringer Ingelheim Investigational Site
Wertheim am Main
1160.85.04921 Boehringer Ingelheim Investigational Site
Wiesbaden
1160.85.04938 Boehringer Ingelheim Investigational Site
Wismar
1160.85.04907 Boehringer Ingelheim Investigational Site
Worms
1160.85.04940 Boehringer Ingelheim Investigational Site
Würzburg
1160.85.04948 Boehringer Ingelheim Investigational Site
Würzburg

Other trials in Germany

France26 sites

1160.85.3306A Boehringer Ingelheim Investigational Site
Angers
1160.85.3318A Boehringer Ingelheim Investigational Site
Bois Guillaume Cédex
1160.85.3333A Boehringer Ingelheim Investigational Site
Bordeaux
1160.85.3310A Boehringer Ingelheim Investigational Site
Caen
1160.85.3311A Boehringer Ingelheim Investigational Site
Clermont-Ferrand
1160.85.3315A Boehringer Ingelheim Investigational Site
Créteil
1160.85.3305A Boehringer Ingelheim Investigational Site
Dijon Cédex
1160.85.3304A Boehringer Ingelheim Investigational Site
Illkirch-Graffenstaden
1160.85.3334A Boehringer Ingelheim Investigational Site
Le Havre
1160.85.3324A Boehringer Ingelheim Investigational Site
Les Lilas
1160.85.3309A Boehringer Ingelheim Investigational Site
Lille
1160.85.3307A Boehringer Ingelheim Investigational Site
Lyon
1160.85.3325A Boehringer Ingelheim Investigational Site
Marseille
1160.85.3323A Boehringer Ingelheim Investigational Site
Metz
1160.85.3321A Boehringer Ingelheim Investigational Site
Nantes Cédex 2
1160.85.3301A Boehringer Ingelheim Investigational Site
Paris
1160.85.3302A Boehringer Ingelheim Investigational Site
Paris
1160.85.3303A Boehringer Ingelheim Investigational Site
Paris
1160.85.3320A Boehringer Ingelheim Investigational Site
Paris
1160.85.3308A Boehringer Ingelheim Investigational Site
Pierre-Bénite
1160.85.3322A Boehringer Ingelheim Investigational Site
Poitiers Cédex
1160.85.3319A Boehringer Ingelheim Investigational Site
Saint Etienne Cédex 2
1160.85.3317A Boehringer Ingelheim Investigational Site
Saint-Saulve
1160.85.3314A Boehringer Ingelheim Investigational Site
Toulouse
1160.85.3313A Boehringer Ingelheim Investigational Site
Toulouse Cédex 9
1160.85.3331A Boehringer Ingelheim Investigational Site
Vannes Cédex

Other trials in France

Austria11 sites

1160.85.4308 Boehringer Ingelheim Investigational Site
Graz
1160.85.4309 Boehringer Ingelheim Investigational Site
Klagenfurt
1160.85.4303 Boehringer Ingelheim Investigational Site
Linz
1160.85.4304 Boehringer Ingelheim Investigational Site
Linz
1160.85.4305 Boehringer Ingelheim Investigational Site
Saint Johann/Tirol
1160.85.4312 Boehringer Ingelheim Investigational Site
Stolzalpe
1160.85.4301 Boehringer Ingelheim Investigational Site
Vienna
1160.85.4302 Boehringer Ingelheim Investigational Site
Vienna
1160.85.4310 Boehringer Ingelheim Investigational Site
Vienna
1160.85.4311 Boehringer Ingelheim Investigational Site
Vienna
1160.85.4307 Boehringer Ingelheim Investigational Site
Wels

Other trials in Austria

Italy10 sites

1160.85.03911 Boehringer Ingelheim Investigational Site
Bari
1160.85.03905 Boehringer Ingelheim Investigational Site
Florence
1160.85.03904 Boehringer Ingelheim Investigational Site
Genova
1160.85.03906 Boehringer Ingelheim Investigational Site
Jesi (an)
1160.85.03914 Boehringer Ingelheim Investigational Site
Latina
1160.85.03901 Boehringer Ingelheim Investigational Site
Mantua
1160.85.03913 Boehringer Ingelheim Investigational Site
Ome (bs)
1160.85.03907 Boehringer Ingelheim Investigational Site
Roma
1160.85.03909 Boehringer Ingelheim Investigational Site
Torino
1160.85.03910 Boehringer Ingelheim Investigational Site
Vimercate (mi)

Other trials in Italy

Spain6 sites

1160.85.3404 Boehringer Ingelheim Investigational Site
Madrid
1160.85.3406 Boehringer Ingelheim Investigational Site
Madrid
1160.85.3405 Boehringer Ingelheim Investigational Site
Málaga
1160.85.3407 Boehringer Ingelheim Investigational Site
Pamplona
1160.85.3401 Boehringer Ingelheim Investigational Site
Valencia
1160.85.3402 Boehringer Ingelheim Investigational Site
Zaragoza

Other trials in Spain

United Kingdom6 sites

1160.85.04405 Boehringer Ingelheim Investigational Site
Basildon
1160.85.04406 Boehringer Ingelheim Investigational Site
Gateshead
1160.85.04402 Boehringer Ingelheim Investigational Site
Halifax
1160.85.04404 Boehringer Ingelheim Investigational Site
London
1160.85.04403 Boehringer Ingelheim Investigational Site
Luton
1160.85.04401 Boehringer Ingelheim Investigational Site
Wigan

Other trials in United Kingdom

Poland5 sites

1160.85.4806 Boehringer Ingelheim Investigational Site
Gmina Świebodzin
1160.85.4805 Boehringer Ingelheim Investigational Site
Kościerzyna
1160.85.4804 Boehringer Ingelheim Investigational Site
Lodz
1160.85.4803 Boehringer Ingelheim Investigational Site
Otwock
1160.85.4802 Boehringer Ingelheim Investigational Site
Piekary Śląskie

Other trials in Poland

Sweden3 sites

1160.85.4603 Boehringer Ingelheim Investigational Site
Kungälv
1160.85.4601 Boehringer Ingelheim Investigational Site
Motala
1160.85.4604 Boehringer Ingelheim Investigational Site
Sollefteå

Other trials in Sweden

Ireland1 site

1160.85.35301 Boehringer Ingelheim Investigational Site
Croom

Other trials in Ireland

About this study

Official title: Observational Cohort Study to Evaluate the Safety and Efficacy of Pradaxa (Dabigatran Etexilate) for the Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Hip Replacement Surgery or Total Knee Replacement Surgery in a Routine Clinical Setting.

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

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 NCT00846807
Study group	Role	What they receive
Patients 75 years or younger		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) During Treatment Period
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).
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)

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)
Total volume of wound drainage is calculated as sum of volume drainage from end of surgery until first dose of Pradaxa plus volume drainage from first dose of Pradaxa and onwards.
Measured: From end of surgery (before first dosing) 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 Single Components of Composite of sVTE 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

Timeline

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

Feb 2009Jul 2011

First posted19 Feb 2009 (estimated)
Study startFeb 2009
Primary completionJul 2011

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.
Publications (1)Papers the sponsor has linked to this study.
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: 5,476 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00846807
Sponsor's protocol ID: 1160.85
Status last verified: Sep 2012
First submitted: 13 Feb 2009
Last updated: 18 Sep 2012
Results posted: Yes, on ClinicalTrials.gov

Publications

Rosencher N, Samama CM, Feuring M, Brueckmann M, Kleine E, Clemens A, Frostick S. Dabigatran etexilate for thromboprophylaxis in over 5000 hip or knee replacement patients in a real-world clinical setting. Thromb J. 2016 Apr 1;14:8. doi: 10.1186/s12959-016-0082-4. eCollection 2016.
PubMed 27042163

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

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
Rhematoid Arthritis, Osteo Arthritis of the Knee
Not yet recruiting
Negative Pressure Wound Therapy Devices in Total Knee Arthroplasty
Wound Surgical, Diabetes
Active, not recruiting
Healthy Living After Knee Replacement
Arthroplasty, Overweight and Obesity

All Arthroplasty, Replacement trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Observational Cohort Study to Evaluate the Safety and Efficacy of Pradaxa (Dabigatran Etexilate) for the Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Hip Replacement Surgery or Total Knee Replacement Surgery in a Routine Clinical Setting.
ClinicalTrials.gov ID: NCT00846807
Acronym / sponsor ID: 1160.85
Conditions: Arthroplasty, Replacement, Thromboembolism
Study type: Observational
Recruitment status: Completed
Enrolment: 5,476 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Feb 2009
Primary completion: Jul 2011 (actual)
First posted: 19 Feb 2009 (estimated)
Results: Posted 28 Aug 2012

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 of the 220 mg dose Pradaxa to generate additional data in predefined sub populations of patients at increased risk of bleeding or VTE

Study design

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

Arm	Type	Receives
Patients 75 years or younger	–	–

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Subgroups of the general population

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

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 <50 ml/min), patients with concomitant therapy of amiodarone, 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

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) During Treatment Period
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).

3 secondary outcomes

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 end of surgery (before first dosing) 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 Single Components of Composite of 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

Results and safety

Results posted to the registry on 28 Aug 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Patients	5,292	4,660

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

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 = 5292
Value	0.72 (0.51, 0.98)

Population analysed: Treated Set (TS) comprises all patients who completed the surgery and received at least 1 dose of dabigatran etexilate.

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

Measure	All Patients n = 5292
Value	1.04 (0.78)

Population analysed: TS

3 secondary outcomes are reported in the full results.

Adverse events

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. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Patients	135 of 5,292 (2.6%)	0 of 5,292 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27042163Rosencher N, Samama CM, Feuring M, Brueckmann M, Kleine E, Clemens A, Frostick S. Dabigatran etexilate for thromboprophylaxis in over 5000 hip or knee replacement patients in a real-world clinical setting. Thromb J. 2016 Apr 1;14:8. doi: 10.1186/s12959-016-0082-4. eCollection 2016.

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

112 sites in 9 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 112 sites in 9 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 1 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 18 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 112 sites in Germany, France, Austria, Italy, Spain and 4 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 28 Aug 2012). 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) During Treatment Period (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 NCT00846807, which also lists 1 linked publication.

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 18 Sep 2012.