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
Overview
- Phase
- Not Applicable
- Intervention
- dabigatran
- Conditions
- Venous Thromboembolism
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 167
- Locations
- 7
- Primary Endpoint
- Percentage of Patients With Major Bleeding Events (MBE) During the Switch-/ Post-switch Treatment Period
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
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)
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
patients after hip or knee replacement
Intervention: dabigatran
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- 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 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 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)
- Percentage of Patients With Major Extra-surgical Site Bleedings 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)
- Volume of Wound Drainage (Post-operative)(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(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))