Venous ThromboembolismNCT01153698

Pradaxa (Dabigatran Etexilate) VTE Prevention After Elective Total Hip or Knee Replacement Surgery

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

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

an open, prospective, observational study to collect data on safety (major bleeding events) and efficacy (symptomatic venous thromboembolism(VTE)) of a switch from Enoxaparin to dabigatran etexilate in patients with total knee replacement (TKR) and total hip replacement (THR) Read more about this study

Who is it for?: Ages 18 to 99 years
Conditions the study is for: Venous Thromboembolism, Arthroplasty, Replacement
What is being tested?: dabigatran
How many people: 167 participants
Where: 7 sitesAustria
Study dates: Aug 2010to 21 Dec 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 99 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: specialist care

Who may be able to join

patients age 18 years or above undergoing elective total hip or knee replacement surgery

Who cannot join

according to the label recommendation for Pradaxa 220 mg QD

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

Austria7 sites

1160.118.43004 Boehringer Ingelheim Investigational Site
Braunau am Inn
1160.118.43002 Boehringer Ingelheim Investigational Site
Ehebichl
1160.118.43005 Boehringer Ingelheim Investigational Site
Graz
1160.118.43016 Boehringer Ingelheim Investigational Site
Stolzalpe
1160.118.43001 Boehringer Ingelheim Investigational Site
Vienna
1160.118.43007 Boehringer Ingelheim Investigational Site
Vienna
1160.118.43011 Boehringer Ingelheim Investigational Site
Vienna

Other trials in Austria

About this study

Official title: Observational Cohort Study to Evaluate the Safety and Efficacy of Switching From Lovenox (Enoxaparin) 40mg to Pradaxa (Dabigatran Etexilate) 220mg in Patients Undergoing Elective Total Hip or Knee Replacement Surgery

Conditions: Venous Thromboembolism, Arthroplasty, Replacement
Being tested: dabigatran
Medical subject headings: Venous Thromboembolism

What participants receive

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

dabigatranDrug
anticoagulation

Study groups in NCT01153698
Study group	Role	What they receive
patients after hip or knee replacement		Not described Receives: Drug: dabigatran

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 the Switch-/ Post-switch Treatment Period
Major bleeding events were defined according to the modified McMaster criteria. The criteria for MBEs 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 last enoxaparin administration until 24 hours after last Pradaxa intake( planned: knee replacement: Day 10 after surgery, hip replacement:Day 28-35 after surgery)
Percentage of Patients With Symptomatic Venous Thromboembolic Events (sVTE) and All-cause Mortality Events During the Switch-/ Post-switch Treatment Period
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 last enoxaparin administration until 24 hours after last Pradaxa intake (planned: knee replacement: Day 10 after surgery, hip replacement:Day 28-35 after surgery)

Secondary outcomes (8)

Percentage of Patients With MBE During Total Treatment Period
MBEs were defined according to the modified McMaster criteria. The criteria for MBEs 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 enoxaparin administration until 24 hours after last Pradaxa intake if switch to Pradaxa was performed or to 35 hours after last enoxaparin administration if no switch was performed
Percentage of Patients With MBE During Pre-switch Treatment Period
MBEs were defined according to the modified McMaster criteria. The criteria for MBEs 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 enoxaparin administration until last enoxaparin administration
Percentage of Patients With sVTE and All-cause Mortality Events During Total Treatment Period
sVTE was defined as the composite of documented symptomatic proximal and distal DVT and documented symptomatic non-fatal PE.
Measured: From first enoxaparin administration until 24 hours after last Pradaxa intake if switch to Pradaxa was performed or to 35 hours after last enoxaparin administration if no switch was performed
Percentage of Patients With sVTE and All-cause Mortality Events During Pre-switch Treatment Period
sVTE was defined as the composite of documented symptomatic proximal and distal DVT and documented symptomatic non-fatal PE.
Measured: From first enoxaparin administration until last enoxaparin administration
Percentage of Patients With sVTE and All-cause Mortality Events During Switch Treatment Period
sVTE was defined as the composite of documented symptomatic proximal and distal DVT and documented symptomatic non-fatal PE.
Symptomatic DVT is defined as clinically symptomatic venous thromboembolic event and symptomatic non-fatal PE is defined as symptomatic pulmonary embolism
Measured: From last enoxaparin administration until first Pradaxa intake
Percentage of Patients With Major Extra-surgical Site Bleedings During Total Treatment Period
Major extra-surgical site bleedings include all major bleedings not occurred at surgical site
Measured: From first enoxaparin administration until 24 hours after last Pradaxa intake if switch to Pradaxa was performed or to 35 hours after last enoxaparin administration if no switch was performed
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 Pradaxa intake
Percentage of Patients With Single Components of Composite of sVTE and All-cause Mortality Events During Total Treatment Period
Total treatment period is defined from first enoxaparin administration to 24h after last Pradaxa intake or to 35h after last enoxaparin administration if no switch was performed.
Measured: From first enoxaparin administration until 24 hours after last Pradaxa intake ( planned: knee replacement: Day 10 after surgery, hip replacement:Day 28-35 after surgery)

Timeline

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

Aug 201021 Dec 2011

First posted30 Jun 2010 (estimated)
Study startAug 2010
Primary completion21 Dec 2011
Study completion21 Dec 2011

Why it stopped: This trial was prematurely discontinued due to low enrolment.

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 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: 167 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01153698
Sponsor's protocol ID: 1160.118
Status last verified: Sep 2023
First submitted: 29 Jun 2010
Last updated: 3 Oct 2023
Results posted: Yes, on ClinicalTrials.gov

Publications

Wurnig C, Clemens A, Rauscher H, Kleine E, Feuring M, Windhager R, Grohs J. Safety and efficacy of switching from low molecular weight heparin to dabigatran in patients undergoing elective total hip or knee replacement surgery. Thromb J. 2015 Nov 26;13:37. doi: 10.1186/s12959-015-0066-9. eCollection 2015.
PubMed 26612979

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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All Venous Thromboembolism trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Oct 2023. 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 Switching From Lovenox (Enoxaparin) 40mg to Pradaxa (Dabigatran Etexilate) 220mg in Patients Undergoing Elective Total Hip or Knee Replacement Surgery
ClinicalTrials.gov ID: NCT01153698
Acronym / sponsor ID: 1160.118
Conditions: Venous Thromboembolism, Arthroplasty, Replacement
Study type: Observational
Recruitment status: TerminatedReason stopped: This trial was prematurely discontinued due to low enrolment.
Enrolment: 167 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Aug 2010
Primary completion: 21 Dec 2011 (actual)
Study completion: 21 Dec 2011 (actual)
First posted: 30 Jun 2010 (estimated)
Results: Posted 4 Jan 2013

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
patients after hip or knee replacement	–	Drug: dabigatran

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: specialist care

Key inclusion criteria (1 listed)

patients age 18 years or above undergoing elective total hip or knee replacement surgery

Key exclusion criteria (1 listed)

according to the label recommendation for Pradaxa 220 mg QD

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

Interventions

Intervention	Type	Arms
dabigatrananticoagulation	Drug	patients after hip or knee replacement

Primary outcome

Percentage of Patients With Major Bleeding Events (MBE) During the Switch-/ Post-switch Treatment Period
Time frame: From last enoxaparin administration until 24 hours after last Pradaxa intake( planned: knee replacement: Day 10 after surgery, hip replacement:Day 28-35 after surgery)
Major bleeding events were defined according to the modified McMaster criteria. The criteria for MBEs 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 Events During the Switch-/ Post-switch Treatment Period
Time frame: From last enoxaparin administration until 24 hours after last Pradaxa intake (planned: knee replacement: Day 10 after surgery, hip replacement:Day 28-35 after surgery)
sVTE was defined as the composite of documented symptomatic proximal and distal deep vein thrombosis (DVT) and documented symptomatic non-fatal pulmonary embolism (PE).

8 secondary outcomes

Percentage of Patients With MBE During Total Treatment Period
Time frame: From first enoxaparin administration until 24 hours after last Pradaxa intake if switch to Pradaxa was performed or to 35 hours after last enoxaparin administration if no switch was performed
Percentage of Patients With MBE During Pre-switch Treatment Period
Time frame: From first enoxaparin administration until last enoxaparin administration
Percentage of Patients With sVTE and All-cause Mortality Events During Total Treatment Period
Time frame: From first enoxaparin administration until 24 hours after last Pradaxa intake if switch to Pradaxa was performed or to 35 hours after last enoxaparin administration if no switch was performed
Percentage of Patients With sVTE and All-cause Mortality Events During Pre-switch Treatment Period
Time frame: From first enoxaparin administration until last enoxaparin administration
Percentage of Patients With sVTE and All-cause Mortality Events During Switch Treatment Period
Time frame: From last enoxaparin administration until first Pradaxa intake
Percentage of Patients With Major Extra-surgical Site Bleedings During Total Treatment Period
Time frame: From first enoxaparin administration until 24 hours after last Pradaxa intake if switch to Pradaxa was performed or to 35 hours after last enoxaparin administration if no switch was performed
Volume of Wound Drainage (Post-operative)
Time frame: From end of surgery (before first dosing) until 24 hours after last Pradaxa intake
Percentage of Patients With Single Components of Composite of sVTE and All-cause Mortality Events During Total Treatment Period
Time frame: From first enoxaparin administration until 24 hours after last Pradaxa intake ( planned: knee replacement: Day 10 after surgery, hip replacement:Day 28-35 after surgery)

Results and safety

Results posted to the registry on 4 Jan 2013, 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	168	139

Primary outcome: Percentage of Patients With Major Bleeding Events (MBE) During the Switch-/ Post-switch Treatment Period

Time frame: From last enoxaparin administration until 24 hours after last Pradaxa intake( planned: knee replacement: Day 10 after surgery, hip replacement:Day 28-35 after surgery). Number (95% Confidence Interval). Unit: Percentage of participants

Measure	All Patients n = 163
Value	0.61 (0.02 to 3.37)

Population analysed: Treated set (TS) reduced to patients with switch-/ post-switch period. TS includes all patients who received at least one dose of enoxaparin or at least one dose of Pradaxa.

Primary outcome: Percentage of Patients With Symptomatic Venous Thromboembolic Events (sVTE) and All-cause Mortality Events During the Switch-/ Post-switch Treatment Period

Time frame: From last enoxaparin administration until 24 hours after last Pradaxa intake (planned: knee replacement: Day 10 after surgery, hip replacement:Day 28-35 after surgery). Number (95% Confidence Interval). Unit: Percentage of participants

Measure	All Patients n = 163
Value	0 (0 to 2.24)

Population analysed: TS reduced to patients with switch-/ post-switch period.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Enoxaparin 40mg: From first enoxaparin administration until first Pradaxa intake (if switch was performed) otherwise until 35h after last Enoxaparin administration; Pradaxa 220mg: From first Pradaxa intake until 24h after last Pradaxa intake. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Enoxaparin 40mg	0 of 166 (0%)	0 of 166 (0%)	Not reported
Pradaxa 220mg	4 of 163 (2.5%)	14 of 163 (8.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26612979Wurnig C, Clemens A, Rauscher H, Kleine E, Feuring M, Windhager R, Grohs J. Safety and efficacy of switching from low molecular weight heparin to dabigatran in patients undergoing elective total hip or knee replacement surgery. Thromb J. 2015 Nov 26;13:37. doi: 10.1186/s12959-015-0066-9. eCollection 2015.

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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

7 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 and Arthroplasty, Replacement, run by Boehringer Ingelheim at 7 sites in Austria.

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: stopped early, as of the sponsor's last update on 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Austria. 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 4 Jan 2013). 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 the Switch-/ Post-switch Treatment Period (time frame: From last enoxaparin administration until 24 hours after last Pradaxa intake( planned: knee replacement: Day 10 after surgery, hip replacement:Day 28-35 after surgery)). 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 NCT01153698, 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 3 Oct 2023.