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This trial was prematurely discontinued due to low enrolment.
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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients after hip or knee replacement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dabigatran | Drug | anticoagulation |
|
| 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) |
| 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. |
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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
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specialist care
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1160.118.43004 Boehringer Ingelheim Investigational Site | Braunau am Inn | Austria | ||||
| 1160.118.43002 Boehringer Ingelheim Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26612979 | Derived | 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. |
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There were 168 patients enrolled and treated. 161 of these patients received enoxaparin and switched to dabigatran etexilate (Pradaxa), 2 patients were only treated with dabigatran etexilate and 5 patients only received enoxaparin but did not switch to dabigatran etexilate.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Patients | receiving at least one dose of enoxaparin 40mg or at least one dose of Pradaxa 220mg |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Patients | receiving at least one dose of enoxaparin 40mg or at least one dose of Pradaxa 220mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Treated set (TS) reduced to patients with switch-/ post-switch period. TS includes all patients who received at least one dose of enoxaparin or at least one dose of Pradaxa. | Posted | Number | 95% Confidence Interval | Percentage of participants | 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) |
|
Enoxaparin 40mg: From first enoxaparin administration until first Pradaxa intake (if switch was performed) otherwise until 35h after last Enoxaparin administration; Pradaxa 220mg: From first Pradaxa intake until 24h after last Pradaxa intake
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Enoxaparin 40mg | All patients treated with enoxaparin |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Seroma | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000069604 | Dabigatran |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
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| 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) |
| Ehebichl |
| Austria |
| 1160.118.43005 Boehringer Ingelheim Investigational Site | Graz | Austria |
| 1160.118.43016 Boehringer Ingelheim Investigational Site | Stolzalpe | Austria |
| 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 |
| Switch to other anticoagulants |
|
| Other |
|
| Not treated with Pradaxa |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
receiving at least one dose of enoxaparin 40mg or at least one dose of Pradaxa 220mg |
|
|
| Primary | 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). | TS reduced to patients with switch-/ post-switch period. | Posted | Number | 95% Confidence Interval | Percentage of participants | 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 | 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. | TS | Posted | Number | 95% Confidence Interval | Percentage of participants | 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 |
|
|
|
| Secondary | 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. | TS reduced to patients with pre-switch period. | Posted | Number | 95% Confidence Interval | Percentage of participants | From first enoxaparin administration until last enoxaparin administration |
|
|
|
| Secondary | 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. | TS | Posted | Number | 95% Confidence Interval | Percentage of participants | 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 |
|
|
|
| Secondary | 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. | TS reduced to patients with pre-switch period. | Posted | Number | 95% Confidence Interval | Percentage of participants | From first enoxaparin administration until last enoxaparin administration |
|
|
|
| Secondary | 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 | TS reduced to patients with switch period. | Posted | Number | 95% Confidence Interval | Percentage of participants | From last enoxaparin administration until first Pradaxa intake |
|
|
|
| Secondary | 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 | TS | Posted | Number | 95% Confidence Interval | Percentage of participants | 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 |
|
|
|
| Secondary | 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. | Treated Set (All patients with non-missing information for both, the volume drainage until first dose of Pradaxa and the volume drainage from first dose of Pradaxa and onwards). | Posted | Mean | Standard Deviation | ml | From end of surgery (before first dosing) until 24 hours after last Pradaxa intake |
|
|
|
| Secondary | 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. | Treated Set | Posted | Number | Number of participants | 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) |
|
|
|
| 0 |
| 166 |
| 0 |
| 166 |
| EG001 | Pradaxa 220mg | All patients treated with Pradaxa | 4 | 163 | 14 | 163 |
| Myocardial infarction | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 14.1 | Systematic Assessment |
|
| Device dislocation | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| Title | Measurements |
|---|---|
|
| All-cause mortality |
|