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

NCT01153698 | Terminated Results

• 1 other identifier: 1160.118
• Study Type: observational
• Target: 167
• Locations: 1 country
• Sites: 7

Brief 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)

Conditions

Venous Thromboembolism; Arthroplasty, Replacement

Outcome Measures

Primary Outcomes (2)

• 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.

  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).

  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

  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

  From first enoxaparin administration until last enoxaparin administration

• Percentage of Patients With sVTE and All-cause Mortality Events During Total Treatment Period

  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

  From first enoxaparin administration until last enoxaparin administration

• Percentage of Patients With sVTE and All-cause Mortality Events During Switch Treatment Period

  From last enoxaparin administration until first Pradaxa intake

Study Arms (1)

patients after hip or knee replacement

Drug: dabigatran

Interventions

dabigatran DRUG

anticoagulation

patients after hip or knee replacement

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

specialist care

You may qualify if:

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

You may not qualify if:

• according to the label recommendation for Pradaxa 220 mg QD

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (7)

1160.118.43004 Boehringer Ingelheim Investigational Site

Braunau am Inn, Austria

Location

1160.118.43002 Boehringer Ingelheim Investigational Site

Ehebichl, Austria

Location

1160.118.43005 Boehringer Ingelheim Investigational Site

Graz, Austria

Location

1160.118.43016 Boehringer Ingelheim Investigational Site

Stolzalpe, Austria

Location

1160.118.43001 Boehringer Ingelheim Investigational Site

Vienna, Austria

Location

1160.118.43007 Boehringer Ingelheim Investigational Site

Vienna, Austria

Location

1160.118.43011 Boehringer Ingelheim Investigational Site

Vienna, Austria

Location

Related Publications (1)

• 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.

  PMID: 26612979 DERIVED

MeSH Terms

Conditions

Venous Thromboembolism

Interventions

Dabigatran

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2010
• First Posted: June 30, 2010
• Study Start: August 1, 2010
• Primary Completion: December 21, 2011
• Study Completion: December 21, 2011
• Last Updated: October 3, 2023
• Results First Posted: January 4, 2013

Record last verified: 2023-09

Locations

AU (7)