MedDataX Logo

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

NCT ID: NCT01153698

Last Updated: 2023-10-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

167 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-08-31

Study Completion Date

2011-12-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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)

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT00846807

Arthroplasty, Replacement Thromboembolism
COMPLETED

Treatment of Patients Undergoing Primary Unilateral Elective Total Knee or Hip Replacement With Dabigatran Etexilate

NCT01184989

Arthroplasty, Replacement Prevention of Venous Thromboembolism Moderate Renal Impairment (CrCl 30-50 mL/Min)
COMPLETED PHASE4

Dabigatran Etexilate in Extended Venous Thromboembolism (VTE) Prevention After Hip Replacement Surgery

NCT00168818

Thromboembolism Arthroplasty, Replacement, Hip
COMPLETED PHASE3

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

NCT00847301

Arthroplasty, Replacement Thromboembolism
COMPLETED

Dabigatran Etexilate Compared With Enoxaparin in Prevention of Venous Thromboembolism (VTE) Following Total Hip Arthroplasty

NCT00657150

Venous Thromboembolism
COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Venous Thromboembolism Arthroplasty, Replacement

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

patients after hip or knee replacement

dabigatran

Intervention Type DRUG

anticoagulation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

dabigatran

anticoagulation

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

according to the label recommendation for Pradaxa 220 mg QD
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

1160.118.43004 Boehringer Ingelheim Investigational Site

Braunau am Inn, , Austria

Site Status

1160.118.43002 Boehringer Ingelheim Investigational Site

Ehebichl, , Austria

Site Status

1160.118.43005 Boehringer Ingelheim Investigational Site

Graz, , Austria

Site Status

1160.118.43016 Boehringer Ingelheim Investigational Site

Stolzalpe, , Austria

Site Status

1160.118.43001 Boehringer Ingelheim Investigational Site

Vienna, , Austria

Site Status

1160.118.43007 Boehringer Ingelheim Investigational Site

Vienna, , Austria

Site Status

1160.118.43011 Boehringer Ingelheim Investigational Site

Vienna, , Austria

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Austria

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 26612979 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1160.118

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Study to Evaluate the Safety and Efficacy of Pradaxar for the Prevention of Venous Thromboembolism in the Mexican Population Undergoing Elective Total Hip or Knee Replacement Surgery
NCT00967447 TERMINATED
Dabigatran Etexilate vs Enoxaparin in Prevention of Venous Thromboembolism (VTE) Post Total Knee Replacement
NCT00152971 COMPLETED PHASE3
Prevention of Venous Thromboembolic Events After Elective Orthopaedic Surgery in Patients Treated With PRADAXA
NCT01139658 COMPLETED
Evaluation of PD 0348292 for Preventing Blood Clots in the Lungs or Deep Leg Veins of Patients After Knee Surgery
NCT00306254 COMPLETED PHASE2
Safety of DAbigatran and RIvaroxaban Versus NAdroparin in the Prevention of Venous Thromboembolism After Knee Arthroplasty Surgery
NCT01431456 COMPLETED PHASE3
ENhanced Recovery and ABbreviated LEngth of Anticoagulation for Thromboprophylaxis After Primary Hip Arthroplasty
NCT06611319 RECRUITING PHASE3
Study of Apixaban for the Prevention of Thrombosis-related Events Following Knee Replacement Surgery
NCT00371683 COMPLETED PHASE3
A Phase 2b Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Hip Arthroplasty
NCT01203098 COMPLETED PHASE2
New Oral Anticoagulant Therapy for the Prevention of Blood Clots Following Hip or Knee Replacement Surgery
NCT00074828 COMPLETED PHASE2
Phase IIa Venous Thromboembolism (VTE) Prevention Study In Total Knee Replacement (TKR)
NCT00541320 WITHDRAWN PHASE2
Prophylaxis of Deep Vein Thrombosis Following Total Hip Arthroplasty
NCT02379663 COMPLETED PHASE4
Study of an Investigational Drug for the Prevention of Thrombosis-related Events Following Knee Replacement Surgery
NCT00452530 COMPLETED PHASE3
RE-MODEL Dabigatran Etexilate 150mg or 220mg Once Daily (o.d.) Versus (v.s.) Enoxaparin 40mg o.d. for Prevention of Thrombosis After Knee Surgery
NCT00168805 COMPLETED PHASE3
Switching Drug Therapy for the Prevention of Blood Clot Formation From Enoxaparin to Rivaroxaban After Orthopedic Surgery for Either Total Hip or Total Knee Replacement
NCT01094886 COMPLETED PHASE3
Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement Surgery
NCT00331838 COMPLETED PHASE2
A Phase 3 Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Knee Arthroplasty
NCT01181102 COMPLETED PHASE3
Prevention of Thromboembolic Events in Total Knee Replacement Patients
NCT03393481 WITHDRAWN PHASE2
PROphylaxis in NOn Major Orthopaedic Surgery
NCT02401594 TERMINATED PHASE3
Dose Ranging Study in Elective Total Hip Replacement Surgery
NCT00338897 COMPLETED PHASE2/PHASE3
Pilot Study Evaluating Alterations in Thrombogenicity and Platelet Reactivity Following Lower Extremity Arthroplasty
NCT01809054 COMPLETED PHASE4
inDividual, Targeted thrombosIS Prophylaxis Versus the Standard 'One Size Fits All' Approach in Patients Undergoing Total hIp or Total kNee replaCemenT
NCT06581965 RECRUITING PHASE4
Single IV Administration of TB-402 for Prophylaxis of Venous Thromboembolic Events (VTE) After Total Hip Replacement Surgery
NCT01344954 COMPLETED PHASE2
Efficacy and Safety of TAK-442 in Subjects Undergoing Total Knee Replacement
NCT00641732 COMPLETED PHASE2
Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Thromboembolism in Patients Undergoing Total Hip Replacement Surgery
NCT00697099 COMPLETED PHASE3
A Study of BIBR 1048 in Prevention of Venous Thromboembolism in Patients With TKR Surgery.
NCT00246025 COMPLETED PHASE2