Arthroplasty, Replacement, Venous Thromboembolism
Conditions
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)
Interventions
DRUGdabigatran
anticoagulation
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Major Bleeding Events (MBE) During the Switch-/ Post-switch Treatment Period | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | sVTE was defined as the composite of documented symptomatic proximal and distal DVT and documented symptomatic non-fatal PE. |
| Percentage of Patients With sVTE and All-cause Mortality Events During Pre-switch Treatment Period | From first enoxaparin administration until last enoxaparin administration | sVTE was defined as the composite of documented symptomatic proximal and distal DVT and documented symptomatic non-fatal PE. |
| Percentage of Patients With sVTE and All-cause Mortality Events During Switch Treatment Period | From last enoxaparin administration until first Pradaxa intake | 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 |
| 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 | 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. |
| Volume of Wound Drainage (Post-operative) | From end of surgery (before first dosing) until 24 hours after last Pradaxa intake | 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. |
| 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) | 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. |
| 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 | Major extra-surgical site bleedings include all major bleedings not occurred at surgical site |
| Percentage of Patients With MBE During Pre-switch Treatment Period | From first enoxaparin administration until last enoxaparin administration | 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. |
Countries
Austria
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| All Patients receiving at least one dose of enoxaparin 40mg or at least one dose of Pradaxa 220mg | 168 |
| Total | 168 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 12 |
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Not treated with Pradaxa | 5 |
| Overall Study | Other | 2 |
| Overall Study | Switch to other anticoagulants | 4 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | All Patients |
|---|---|
| Age, Continuous | 60.9 Years STANDARD_DEVIATION 9.2 |
| Sex: Female, Male Female | 96 Participants |
| Sex: Female, Male Male | 72 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 166 | 14 / 163 |
| serious Total, serious adverse events | 0 / 166 | 4 / 163 |
Outcome results
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.
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)
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Patients | Percentage of Patients With Major Bleeding Events (MBE) During the Switch-/ Post-switch Treatment Period | 0.61 Percentage of participants |
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).
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)
Population: TS reduced to patients with switch-/ post-switch period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Patients | Percentage of Patients With Symptomatic Venous Thromboembolic Events (sVTE) and All-cause Mortality Events During the Switch-/ Post-switch Treatment Period | 0 Percentage of participants |
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
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
Population: TS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Patients | Percentage of Patients With Major Extra-surgical Site Bleedings During Total Treatment Period | 0 Percentage of participants |
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.
Time frame: From first enoxaparin administration until last enoxaparin administration
Population: TS reduced to patients with pre-switch period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Patients | Percentage of Patients With MBE During Pre-switch Treatment Period | 0 Percentage of participants |
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.
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
Population: TS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Patients | Percentage of Patients With MBE During Total Treatment Period | 0.60 Percentage of participants |
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.
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)
Population: Treated Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Patients | Percentage of Patients With Single Components of Composite of sVTE and All-cause Mortality Events During Total Treatment Period | Documented symptomatic proximal DVT | 0 Number of participants |
| All Patients | Percentage of Patients With Single Components of Composite of sVTE and All-cause Mortality Events During Total Treatment Period | Documented symptomatic distal DVT | 0 Number of participants |
| All Patients | Percentage of Patients With Single Components of Composite of sVTE and All-cause Mortality Events During Total Treatment Period | Documented symptomatic non-fatal PE | 0 Number of participants |
| All Patients | Percentage of Patients With Single Components of Composite of sVTE and All-cause Mortality Events During Total Treatment Period | All-cause mortality | 0 Number of participants |
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.
Time frame: From first enoxaparin administration until last enoxaparin administration
Population: TS reduced to patients with pre-switch period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Patients | Percentage of Patients With sVTE and All-cause Mortality Events During Pre-switch Treatment Period | 0 Percentage of participants |
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
Time frame: From last enoxaparin administration until first Pradaxa intake
Population: TS reduced to patients with switch period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Patients | Percentage of Patients With sVTE and All-cause Mortality Events During Switch Treatment Period | 0 Percentage of participants |
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.
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
Population: TS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Patients | Percentage of Patients With sVTE and All-cause Mortality Events During Total Treatment Period | 0 Percentage of participants |
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.
Time frame: From end of surgery (before first dosing) until 24 hours after last Pradaxa intake
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Patients | Volume of Wound Drainage (Post-operative) | 462.1 ml | Standard Deviation 275.2 |