Prevention of Venous Thromboembolic Events After Elective Orthopaedic Surgery in Patients Treated With PRADAXA

An observational study of Venous Thromboembolism, run by Boehringer Ingelheim at 53 sites in France.

Completed

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

Trial summary

Observational cohort study on the prevention of venous thromboembolic events after elective orthopaedic surgery for Total Knee Replacement or Total Hip Replacement iin patients treated with PRADAXA to evaluate the efficacy ant safety of Pradaxa in real-life conditions Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Venous Thromboembolism
How many people: 1,676 participants
Where: 53 sitesFrance
Study dates: Aug 2010to Sep 2012
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: Demographic, medical and chirurgical characteristics

Who may be able to join

Patients treated with Pradaxa undergoing surgery for Total Knee Replacement or Total Hip Replacement
Patients 18 years of age or older at the time of recruitment

Who cannot join

Patients presenting contraindication to prescription of Pradaxa
Patients in whom long term Anti vitamin K treatment is indicated

Trial locations and contacts

53 sites in 1 country.

City, postcode or hospital

53 sites in 1 country

France53 sites

Boehringer Ingelheim Investigational Site 30
Angers
Boehringer Ingelheim Investigational Site 41
Arles
Boehringer Ingelheim Investigational Site 40
Beauvais
Boehringer Ingelheim Investigational Site 2
Berck
Boehringer Ingelheim Investigational Site 25
Bordeaux
Boehringer Ingelheim Investigational Site 45
Boulogne-sur-Mer
Boehringer Ingelheim Investigational Site 13
Bruay-la-Buissière
Boehringer Ingelheim Investigational Site 42
Cahors
Boehringer Ingelheim Investigational Site 50
Castelnau-le-Lez
Boehringer Ingelheim Investigational Site 36
Chantilly
Boehringer Ingelheim Investigational Site 35
Châteaubernard
Boehringer Ingelheim Investigational Site 10
Châteaubriant
Boehringer Ingelheim Investigational Site 9
Clinique Des Maussins-Paris
Boehringer Ingelheim Investigational Site 44
Dole
Boehringer Ingelheim Investigational Site 3
Dracy-le-Fort
Boehringer Ingelheim Investigational Site 46
Haguenau
Boehringer Ingelheim Investigational Site 33
Illkirch-Graffenstaden
Boehringer Ingelheim Investigational Site 23
La Roche-sur-Yon
Boehringer Ingelheim Investigational Site 22
Lannion
Boehringer Ingelheim Investigational Site 27
Le Blanc Menil
Boehringer Ingelheim Investigational Site 31
Le Port-Marly
Boehringer Ingelheim Investigational Site 21
Libourne
Boehringer Ingelheim Investigational Site 5
Lille
Boehringer Ingelheim Investigational Site 19
Lyon
Boehringer Ingelheim Investigational Site 12
Mâcon
Boehringer Ingelheim Investigational Site 47
Marcq En Bareuil
Boehringer Ingelheim Investigational Site 28
Mérignac
Boehringer Ingelheim Investigational Site 26
Morlaix
Boehringer Ingelheim Investigational Site 48
Nancy
Boehringer Ingelheim Investigational Site 7
Nancy
Boehringer Ingelheim Investigational Site 8
Nice
Boehringer Ingelheim Investigational Site 11
Paris
Boehringer Ingelheim Investigational Site 17
Paris
Boehringer Ingelheim Investigational Site 6
Paris
Boehringer Ingelheim Investigational Site 24
Perpignan
Boehringer Ingelheim Investigational Site 49
Ploemeur
Boehringer Ingelheim Investigational Site 14
Poissy
Boehringer Ingelheim Investigational Site 39
Pontarlier
Boehringer Ingelheim Investigational Site 43
Pringy
Boehringer Ingelheim Investigational Site 15
Reims
Boehringer Ingelheim Investigational Site 20
Rennes
Boehringer Ingelheim Investigational Site 53
Saint Colombe Les Viennes
Boehringer Ingelheim Investigational Site 52
Saint-Georges-de-Didonne
Boehringer Ingelheim Investigational Site 4
Saint-Grégoire
Boehringer Ingelheim Investigational Site 18
Saint-Priest-en-Jarez
Boehringer Ingelheim Investigational Site 32
Saint-Priest-en-Jarez
Boehringer Ingelheim Investigational Site 51
Saint-Saulve
Boehringer Ingelheim Investigational Site 37
Saumur
Boehringer Ingelheim Investigational Site 34
Semur-en-Auxois
Boehringer Ingelheim Investigational Site 1
Strasbourg
Boehringer Ingelheim Investigational Site 38
Toulouse
Boehringer Ingelheim Investigational Site 29
Tourcoing
Boehringer Ingelheim Investigational Site 16
Villeneuve-sur-Lot

Other trials in France

About this study

Official title: Observational Cohort Study on the Prevention of Venous Thromboembolic Events After Elective Orthopaedic Surgery in Patients Treated With PRADAXA

Conditions: Venous Thromboembolism
Medical subject headings: Venous Thromboembolism

What participants receive

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

Study groups in NCT01139658
Study group	Role	What they receive
All comers		Not described

What is being measured

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

Occurrence of Symptomatic Venous Thromboembolic Events
Occurrence of symptomatic venous thromboembolic (VTE) events in patients treated with Pradaxa (dabigatran etexilate) after orthopaedic surgery (either Total Hip Replacement (THR) or Total Knee Replacement surgery (TKR)). Symptomatic VTE events were defined as a confirmed proximal or distal deep vein thrombosis (DVT) or a confirmed pulmonary embolism (PE).
Measured: 11 weeks
Occurrence of Major Bleeding Events
Occurrence of major bleeding events (MBEs) in patients treated with Pradaxa (dabigatran etexilate) after orthopaedic surgery (either THR or TKR surgery). MBEs were defined as any fatal haemorrhage, any overt bleeding greater than could be expected combined with a loss of haemoglobin ≥ 2 g/dL or requiring transfusion ≥ 2 packed red blood cells units (PRBC), any symptomatic retroperitoneal, intracranial, intraocular or intraspinal haemorrhage or any bleeding requireing treatment cessation or reoperation.
a confirmed proximal or distal deep vein thrombosis (DVT) or a confirmed pulmonary emboliam (PE).
Measured: 11 weeks

Secondary outcomes (14)

Dosage of Pradaxa at Initiation
Measured: Baseline
Duration Between Surgery and First Dose of Pradaxa
Measured: 11 weeks
Duration of Treatment
Measured: 11 weeks
Proportion of Patients With a Preoperative ALT Measurement
Measured: 11 weeks
Adherence to Treatment
The adherence to treatment was measured by patient declaration.
Measured: 11 weeks
Concomitant Treatments
Concomitant treatments prescribed at hospital discharge.
Measured: 11 weeks
Number of Patients Who Switched to Another Anticoagulant Therapy
Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.
Measured: 11 weeks
Prescription for the Surveillance of the Platelet Count on the Day of Hospital Discharge
Measured: 11 weeks
Prescription for Nursing Care and Nurse Visits on the Day of Hospital Discharge
Measured: 11 weeks
Reasons for Nurse Visits on the Day of Hospital Discharge
Measured: 11 weeks
Frequency of Nurse Visits on the Day of Hospital Discharge
Measured: 11 weeks
Duration of Unplanned Hospitalizations at Visit 3
Measured: 11 weeks
Reasons for Unplanned Hospitalizations at Visit 3
Measured: 11 weeks
Reasons for Usual Follow-up
Measured: 11 weeks

Timeline

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

Aug 2010Sep 2012

First posted8 Jun 2010 (estimated)
Study startAug 2010
Primary completionSep 2012
Study completionSep 2012

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 Venous ThromboembolismStudies 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: 1,676 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01139658
Sponsor's protocol ID: 1160.102
Status last verified: Nov 2013
First submitted: 7 Jun 2010
Last updated: 16 Jan 2014
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

RecruitingPhase 3
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
Venous Thromboembolism (VTE)
RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Venous Thromboembolism (VTE)
RecruitingPhase 3
REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
Cancer-Associated Thrombosis (CAT)
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
Recruiting
DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis
Venous Thromboembolism, Deep Venous Thrombosis

All Venous Thromboembolism trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Observational Cohort Study on the Prevention of Venous Thromboembolic Events After Elective Orthopaedic Surgery in Patients Treated With PRADAXA
ClinicalTrials.gov ID: NCT01139658
Acronym / sponsor ID: 1160.102
Conditions: Venous Thromboembolism
Study type: Observational
Recruitment status: Completed
Enrolment: 1,676 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Aug 2010
Primary completion: Sep 2012 (actual)
Study completion: Sep 2012 (actual)
First posted: 8 Jun 2010 (estimated)
Results: Posted 16 Jan 2014

Clinical summary

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

Study design

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

Arm	Type	Receives
All comers	–	–

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Demographic, medical and chirurgical characteristics

Key inclusion criteria (2 listed)

Patients treated with Pradaxa undergoing surgery for Total Knee Replacement or Total Hip Replacement
Patients 18 years of age or older at the time of recruitment

Key exclusion criteria (2 listed)

Patients presenting contraindication to prescription of Pradaxa
Patients in whom long term Anti vitamin K treatment is indicated

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

Occurrence of Symptomatic Venous Thromboembolic Events
Time frame: 11 weeks
Occurrence of symptomatic venous thromboembolic (VTE) events in patients treated with Pradaxa (dabigatran etexilate) after orthopaedic surgery (either Total Hip Replacement (THR) or Total Knee Replacement surgery (TKR)). Symptomatic VTE events were defined as a confirmed proximal or distal deep vein thrombosis (DVT) or a confirmed pulmonary embolism (PE).
Occurrence of Major Bleeding Events
Time frame: 11 weeks
Occurrence of major bleeding events (MBEs) in patients treated with Pradaxa (dabigatran etexilate) after orthopaedic surgery (either THR or TKR surgery). MBEs were defined as any fatal haemorrhage, any overt bleeding greater than could be expected combined with a loss of haemoglobin ≥ 2 g/dL or requiring transfusion ≥ 2 packed red blood cells units (PRBC), any symptomatic retroperitoneal, intracranial, intraocular or intraspinal haemorrhage or any bleeding requireing treatment cessation or reoperation. a confirmed proximal or distal deep vein thrombosis (DVT) or a confirmed pulmonary emboliam (PE).

14 secondary outcomes

Dosage of Pradaxa at Initiation
Time frame: Baseline
Duration Between Surgery and First Dose of Pradaxa
Time frame: 11 weeks
Duration of Treatment
Time frame: 11 weeks
Proportion of Patients With a Preoperative ALT Measurement
Time frame: 11 weeks
Adherence to Treatment
Time frame: 11 weeks
Concomitant Treatments
Time frame: 11 weeks
Number of Patients Who Switched to Another Anticoagulant Therapy
Time frame: 11 weeks
Prescription for the Surveillance of the Platelet Count on the Day of Hospital Discharge
Time frame: 11 weeks
Prescription for Nursing Care and Nurse Visits on the Day of Hospital Discharge
Time frame: 11 weeks
Reasons for Nurse Visits on the Day of Hospital Discharge
Time frame: 11 weeks
Frequency of Nurse Visits on the Day of Hospital Discharge
Time frame: 11 weeks
Duration of Unplanned Hospitalizations at Visit 3
Time frame: 11 weeks
Reasons for Unplanned Hospitalizations at Visit 3
Time frame: 11 weeks
Reasons for Usual Follow-up
Time frame: 11 weeks

Results and safety

Results posted to the registry on 16 Jan 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Total Knee Replacement	747	691
Total Hip Replacement	929	816

Primary outcome: Occurrence of Symptomatic Venous Thromboembolic Events

Time frame: 11 weeks. Number. Unit: participants

Measure	Total Knee Replacement n = 746	Total Hip Replacement n = 929
Value	19	5

Population analysed: Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.

Primary outcome: Occurrence of Major Bleeding Events

Time frame: 11 weeks. Number. Unit: participants

Measure	Total Knee Replacement n = 746	Total Hip Replacement n = 929
Value	8	16

Population analysed: Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.

14 secondary outcomes are reported in the full results.

Adverse events

Time frame: 11 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Total Knee Replacement	48 of 746 (6.4%)	0 of 746 (0%)	Not reported
Total Hip Replacement	37 of 929 (4%)	0 of 929 (0%)	Not reported

Limitations and caveats (from the sponsor): Data for the following secondary endpoints were not collected: Medical appointments with a general practitioner or specialist at visit 3, Frequency of medical appointments at visit 3, Prescription received at visit 3.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Venous Thromboembolism

RecruitingPhase 3
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
Venous Thromboembolism (VTE)
RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Venous Thromboembolism (VTE)
RecruitingPhase 3
REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
Cancer-Associated Thrombosis (CAT)
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
Recruiting
DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis
Venous Thromboembolism, Deep Venous Thrombosis

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 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Venous Thromboembolism, run by Boehringer Ingelheim at 53 sites in France.

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 2 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 16 Jan 2014. 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. 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 16 Jan 2014). 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?

Occurrence of Symptomatic Venous Thromboembolic Events (time frame: 11 weeks). 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 NCT01139658.

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 16 Jan 2014.