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

Study Overview
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Brief Summary
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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)

Official Title
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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
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Venous Thromboembolism, Arthroplasty, Replacement

Intervention / Treatment
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* Drug: dabigatran


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients after hip or knee replacement<br> | Drug: dabigatran<br>* anticoagulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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 | 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 | 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. | 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. | 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) |