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)
Study Type
OBSERVATIONAL
Enrollment
167
anticoagulation
1160.118.43004 Boehringer Ingelheim Investigational Site
Braunau am Inn, Austria
1160.118.43002 Boehringer Ingelheim Investigational Site
Ehebichl, Austria
1160.118.43005 Boehringer Ingelheim Investigational Site
Graz, Austria
1160.118.43016 Boehringer Ingelheim Investigational Site
Stolzalpe, Austria
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.
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)
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).
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)
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.
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
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1160.118.43001 Boehringer Ingelheim Investigational Site
Vienna, Austria
1160.118.43007 Boehringer Ingelheim Investigational Site
Vienna, Austria
1160.118.43011 Boehringer Ingelheim Investigational Site
Vienna, Austria
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.
Time frame: 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.
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
sVTE was defined as the composite of documented symptomatic proximal and distal DVT and documented symptomatic non-fatal PE.
Time frame: 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
Time frame: 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
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)
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.
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
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.
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)