Arthroplasty, Replacement, Knee, Thromboembolism
Conditions
Brief summary
A phase III, randomised, parallel-group, double-blind, active controlled study to investigate the ef ficacy and safety of two different dose regimens of orally administered dabigatran etexilate capsule s \[150 or 220 mg once daily starting with a half dose (i.e.75 or 110 mg) on the day of surgery\] comp ared to subcutaneous enoxaparin 40 mg once daily for 6 to 10 days, in prevention of venous thromboem bolism in patients with primary elective total knee replacement surgery. RE-MODEL (Thromboembolism prevention after knee surgery)
Interventions
DRUGenoxaparin
40 mg once daily
DRUGdabigatran etexilate
150 mg once daily
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion criteria (selected): * Patients (18 years or older) scheduled to undergo a primary, unilateral, elect ive total knee replacement * Written Informed Consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period | First administration until 6-10 days | Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine bilateral venography), symptomatic DVT (confirmed by venous compression ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy). All of these components and all deaths were centrally adjudicated by the VTE events committee, which was not aware of the treatment allocation of the patients. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Proximal Deep Vein Thrombosis During Treatment Period | First administration until 6-10 days | Proximal Deep Vein Thrombosis as adjudicated by the VTE events committee |
| Number of Participants With Total Deep Vein Thrombosis During Treatment Period | First administration until 6-10 days | Total Deep Vein Thrombosis as adjudicated by the VTE events committee |
| Number of Participants With Symptomatic Deep Vein Thrombosis During Treatment Period | First administration until 6-10 days | Symptomatic Deep Vein Thrombosis, confirmed by venous compression ultrasound, venography or autopsy, and as adjudicated by the VTE events committee |
| Number of Participants With Pulmonary Embolism During Treatment Period | First administration until 6-10 days | Pulmonary embolism confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy, and as adjudicated by the VTE events committee |
| Number of Participants Who Died During Treatment Period | First administration until 6-10 days | All cause death, as adjudicated by the VTE events committee |
| Number of Participants With Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period | First administration until 6-10 days | Major Venous Thromboembolic Event (VTE) is defined as proximal DVT and PE, as adjudicated by the VTE events committee |
| Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period | First administration until 6-10 days | Major bleeding events were defined as * 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 Clinically-relevant was defined as * spontaneous skin hematoma greater than or equal to 25 cm² * wound hematoma greater than or equal to 100 cm² * spontaneous nose bleed lasting longer than 5 min * macroscopic hematuria spontaneous or lasting longer than 24 hours if associated with an intervention * spontaneous rectal bleeding (more than a spot on toilet paper) * gingival bleeding lasting longer than 5 min * any other bleeding event considered clinically relevant by the investigator Minor bleeding events were defined as all other bleeding events that did not fulfil the criteria from above. |
| Blood Transfusion | Day 1 | Blood transfusion for treated and operated patients on Day of surgery. |
| Volume of Blood Loss | Day 1 | Volume of blood loss for treated and operated patients during surgery. |
| Laboratory Analyses | First administration to end of study | Frequency of patients with possible clinically significant abnormalities. |
| Number of Participants With Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period | 3 months | Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine bilateral venography), symptomatic DVT (confirmed by venous compression ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy). |
Countries
Australia, Austria, Belgium, Czechia, Denmark, Finland, France, Germany, Hungary, Italy, Netherlands, Poland, South Africa, Spain, Sweden
Participant flow
Recruitment details
The treatment period is from first administration of study medication, until 3 days after last administration of study medication. Treatment duration is planned for 8 days. The study period is from first administration of study medication until day 84 - 91.
Pre-assignment details
Whilst 2101 patients were enrolled/randomised to treatment prior to surgery in this trial, only 2076 started treatment. Therefore, 25 patients were randomised but not treated (treatment was planned to start post surgery).
Participants by arm
| Arm | Count |
|---|---|
| Dabigatran 220mg qd (once daily) oral | 679 |
| Dabigatran 150mg qd (once daily) oral | 703 |
| Enoxaparin 40mg qd (once daily) subcutaneous | 694 |
| Total | 2,076 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 7 | 11 | 16 |
| Overall Study | Lost to Follow-up | 12 | 17 | 11 |
| Overall Study | Other | 24 | 21 | 22 |
| Overall Study | Protocol Violation | 12 | 11 | 8 |
| Overall Study | Withdrawal by Subject | 16 | 18 | 21 |
| Treatment | Adverse Event | 25 | 26 | 32 |
| Treatment | Other | 18 | 18 | 17 |
| Treatment | Protocol Violation | 3 | 5 | 5 |
| Treatment | Withdrawal by Subject | 3 | 7 | 8 |
Baseline characteristics
| Characteristic | Dabigatran 220mg | Dabigatran 150mg | Enoxaparin | Total |
|---|---|---|---|---|
| Age, Continuous | 67.3 Years STANDARD_DEVIATION 9 | 67.5 Years STANDARD_DEVIATION 8.8 | 68.3 Years STANDARD_DEVIATION 8.8 | 67.7 Years STANDARD_DEVIATION 8.9 |
| Body Mass Index N=(677;702;692;2071) | 29.9 kg/m^2 STANDARD_DEVIATION 4.9 | 30.1 kg/m^2 STANDARD_DEVIATION 5 | 29.8 kg/m^2 STANDARD_DEVIATION 4.9 | 29.9 kg/m^2 STANDARD_DEVIATION 4.9 |
| Sex: Female, Male Female | 441 Participants | 451 Participants | 478 Participants | 1370 Participants |
| Sex: Female, Male Male | 238 Participants | 252 Participants | 216 Participants | 706 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 405 / 679 | 438 / 703 | 426 / 694 |
| serious Total, serious adverse events | 31 / 679 | 44 / 703 | 43 / 694 |
Outcome results
Primary
Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period
Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine bilateral venography), symptomatic DVT (confirmed by venous compression ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy). All of these components and all deaths were centrally adjudicated by the VTE events committee, which was not aware of the treatment allocation of the patients.
Time frame: First administration until 6-10 days
Population: Full Analysis Set (all patients who had surgery and were randomised, received treatment, had an evaluable venogram for distal and proximal Deep Vein Thrombosis, or had confirmed symptomatic Deep Vein Thrombosis, Pulmonary Embolism, or had died)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran 220mg | Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period | 183 Participants |
| Dabigatran 150mg | Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period | 213 Participants |
| Enoxaparin | Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period | 193 Participants |
Comparison: Risk difference versus Enoxaparinp-value: 0.664895% CI: [-7.3, 4.6]Normal approximation
Comparison: Risk difference versus Enoxaparinp-value: 0.355395% CI: [-3.1, 8.7]Normal approximation
Secondary
Blood Transfusion
Blood transfusion for treated and operated patients on Day of surgery.
Time frame: Day 1
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dabigatran 220mg | Blood Transfusion | Patients with >=1 transfusions | 242 participants |
| Dabigatran 220mg | Blood Transfusion | Patients with >=1 non-autologous transfusions | 87 participants |
| Dabigatran 150mg | Blood Transfusion | Patients with >=1 transfusions | 253 participants |
| Dabigatran 150mg | Blood Transfusion | Patients with >=1 non-autologous transfusions | 86 participants |
| Enoxaparin | Blood Transfusion | Patients with >=1 transfusions | 265 participants |
| Enoxaparin | Blood Transfusion | Patients with >=1 non-autologous transfusions | 120 participants |
Secondary
Laboratory Analyses
Frequency of patients with possible clinically significant abnormalities.
Time frame: First administration to end of study
Population: Treated patients
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dabigatran 220mg | Laboratory Analyses | AST increase N=(620;645;636) | 9 participants |
| Dabigatran 220mg | Laboratory Analyses | AST decrease N=(620;645;636) | 0 participants |
| Dabigatran 220mg | Laboratory Analyses | ALT increase N=(621;645;637) | 16 participants |
| Dabigatran 220mg | Laboratory Analyses | ALT decrease N=(621;645;637) | 0 participants |
| Dabigatran 220mg | Laboratory Analyses | Bilirubin increase N=(619;644;635) | 19 participants |
| Dabigatran 220mg | Laboratory Analyses | Bilirubin decrease N=(619;644;635) | 0 participants |
| Dabigatran 150mg | Laboratory Analyses | Bilirubin decrease N=(619;644;635) | 0 participants |
| Dabigatran 150mg | Laboratory Analyses | AST increase N=(620;645;636) | 6 participants |
| Dabigatran 150mg | Laboratory Analyses | ALT decrease N=(621;645;637) | 0 participants |
| Dabigatran 150mg | Laboratory Analyses | Bilirubin increase N=(619;644;635) | 23 participants |
| Dabigatran 150mg | Laboratory Analyses | AST decrease N=(620;645;636) | 0 participants |
| Dabigatran 150mg | Laboratory Analyses | ALT increase N=(621;645;637) | 21 participants |
| Enoxaparin | Laboratory Analyses | AST decrease N=(620;645;636) | 0 participants |
| Enoxaparin | Laboratory Analyses | ALT increase N=(621;645;637) | 24 participants |
| Enoxaparin | Laboratory Analyses | Bilirubin decrease N=(619;644;635) | 0 participants |
| Enoxaparin | Laboratory Analyses | ALT decrease N=(621;645;637) | 0 participants |
| Enoxaparin | Laboratory Analyses | AST increase N=(620;645;636) | 9 participants |
| Enoxaparin | Laboratory Analyses | Bilirubin increase N=(619;644;635) | 14 participants |
Secondary
Number of Participants Who Died During Treatment Period
All cause death, as adjudicated by the VTE events committee
Time frame: First administration until 6-10 days
Population: Full Analysis Set - op
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran 220mg | Number of Participants Who Died During Treatment Period | 1 Participants |
| Dabigatran 150mg | Number of Participants Who Died During Treatment Period | 1 Participants |
| Enoxaparin | Number of Participants Who Died During Treatment Period | 1 Participants |
Comparison: Comparison versus Enoxaparinp-value: 1Fisher Exact
Comparison: Comparison versus Enoxaparinp-value: 1Fisher Exact
Secondary
Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period
Major bleeding events were defined as * 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 Clinically-relevant was defined as * spontaneous skin hematoma greater than or equal to 25 cm² * wound hematoma greater than or equal to 100 cm² * spontaneous nose bleed lasting longer than 5 min * macroscopic hematuria spontaneous or lasting longer than 24 hours if associated with an intervention * spontaneous rectal bleeding (more than a spot on toilet paper) * gingival bleeding lasting longer than 5 min * any other bleeding event considered clinically relevant by the investigator Minor bleeding events were defined as all other bleeding events that did not fulfil the criteria from above.
Time frame: First administration until 6-10 days
Population: Treated set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dabigatran 220mg | Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period | None | 569 Participants |
| Dabigatran 220mg | Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period | Major | 10 Participants |
| Dabigatran 220mg | Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period | Minor | 60 Participants |
| Dabigatran 220mg | Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period | Clinically relevant | 40 Participants |
| Dabigatran 150mg | Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period | Minor | 59 Participants |
| Dabigatran 150mg | Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period | None | 587 Participants |
| Dabigatran 150mg | Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period | Clinically relevant | 48 Participants |
| Dabigatran 150mg | Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period | Major | 9 Participants |
| Enoxaparin | Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period | None | 579 Participants |
| Enoxaparin | Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period | Clinically relevant | 37 Participants |
| Enoxaparin | Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period | Minor | 69 Participants |
| Enoxaparin | Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period | Major | 9 Participants |
Comparison: Comparison versus Enoxaparinp-value: 0.8209Fisher Exact
Comparison: Comparison versus Enoxaparinp-value: 1Fisher Exact
Secondary
Number of Participants With Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period
Major Venous Thromboembolic Event (VTE) is defined as proximal DVT and PE, as adjudicated by the VTE events committee
Time frame: First administration until 6-10 days
Population: Full Analysis Set - major (all patients who had surgery and were randomised, received treatment, had an evaluable venogram for proximal Deep Vein Thrombosis, or had confirmed symptomatic Deep Vein Thrombosis, Pulmonary Embolism, or had died by a Venous Thromboembolic Event-related death)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran 220mg | Number of Participants With Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period | 13 Participants |
| Dabigatran 150mg | Number of Participants With Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period | 20 Participants |
| Enoxaparin | Number of Participants With Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period | 18 Participants |
Comparison: Risk difference versus Enoxaparinp-value: 0.37695% CI: [-3.1, 1.2]Normal approximation
Comparison: Risk difference versus Enoxaparinp-value: 0.815195% CI: [-2, 2.6]Normal approximation
Secondary
Number of Participants With Proximal Deep Vein Thrombosis During Treatment Period
Proximal Deep Vein Thrombosis as adjudicated by the VTE events committee
Time frame: First administration until 6-10 days
Population: Full Analysis Set - pDVT (all patients who had surgery and were randomised, received treatment, had an evaluable venogram for proximal Deep Vein Thrombosis, or had confirmed symptomatic Deep Vein Thrombosis)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran 220mg | Number of Participants With Proximal Deep Vein Thrombosis During Treatment Period | 13 Participants |
| Dabigatran 150mg | Number of Participants With Proximal Deep Vein Thrombosis During Treatment Period | 18 Participants |
| Enoxaparin | Number of Participants With Proximal Deep Vein Thrombosis During Treatment Period | 17 Participants |
Comparison: Risk difference versus Enoxaparinp-value: 0.471595% CI: [-2.8, 1.3]Normal approximation
Comparison: Risk difference versus Enoxaparinp-value: 0.932595% CI: [-2.1, 2.3]Normal approximation
Secondary
Number of Participants With Pulmonary Embolism During Treatment Period
Pulmonary embolism confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy, and as adjudicated by the VTE events committee
Time frame: First administration until 6-10 days
Population: Full Analysis Set - op
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran 220mg | Number of Participants With Pulmonary Embolism During Treatment Period | 0 Participants |
| Dabigatran 150mg | Number of Participants With Pulmonary Embolism During Treatment Period | 1 Participants |
| Enoxaparin | Number of Participants With Pulmonary Embolism During Treatment Period | 1 Participants |
Comparison: Comparison versus Enoxaparinp-value: 1Fisher Exact
Comparison: Comparison versus Enoxaparinp-value: 1Fisher Exact
Secondary
Number of Participants With Symptomatic Deep Vein Thrombosis During Treatment Period
Symptomatic Deep Vein Thrombosis, confirmed by venous compression ultrasound, venography or autopsy, and as adjudicated by the VTE events committee
Time frame: First administration until 6-10 days
Population: Full Analysis Set - op (all patients who are treated and operated)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran 220mg | Number of Participants With Symptomatic Deep Vein Thrombosis During Treatment Period | 1 Participants |
| Dabigatran 150mg | Number of Participants With Symptomatic Deep Vein Thrombosis During Treatment Period | 3 Participants |
| Enoxaparin | Number of Participants With Symptomatic Deep Vein Thrombosis During Treatment Period | 8 Participants |
Comparison: Comparison versus Enoxaparinp-value: 0.0385Fisher Exact
Comparison: Comparison versus Enoxaparinp-value: 0.1414Fisher Exact
Secondary
Number of Participants With Total Deep Vein Thrombosis During Treatment Period
Total Deep Vein Thrombosis as adjudicated by the VTE events committee
Time frame: First administration until 6-10 days
Population: Full Analysis Set - tDVT (all patients who had surgery and were randomised, received treatment, had an evaluable venogram, or had confirmed symptomatic Deep Vein Thrombosis)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran 220mg | Number of Participants With Total Deep Vein Thrombosis During Treatment Period | 182 Participants |
| Dabigatran 150mg | Number of Participants With Total Deep Vein Thrombosis During Treatment Period | 211 Participants |
| Enoxaparin | Number of Participants With Total Deep Vein Thrombosis During Treatment Period | 192 Participants |
Comparison: Risk difference versus Enoxaparinp-value: 0.646395% CI: [-7.3, 4.5]Normal approximation
Comparison: Risk difference versus Enoxaparinp-value: 0.37495% CI: [-3.2, 8.6]Normal approximation
Secondary
Number of Participants With Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period
Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine bilateral venography), symptomatic DVT (confirmed by venous compression ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy).
Time frame: 3 months
Population: Patients with any data available during follow-up
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dabigatran 220mg | Number of Participants With Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period | Total VTE and all-cause mortality | 4 Participants |
| Dabigatran 220mg | Number of Participants With Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period | death | 1 Participants |
| Dabigatran 220mg | Number of Participants With Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period | asymptotic Deep Vein Thrombosis | 0 Participants |
| Dabigatran 220mg | Number of Participants With Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period | Pulmonary Embolism | 2 Participants |
| Dabigatran 220mg | Number of Participants With Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period | symptotic Deep Vein Thrombosis | 1 Participants |
| Dabigatran 150mg | Number of Participants With Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period | symptotic Deep Vein Thrombosis | 2 Participants |
| Dabigatran 150mg | Number of Participants With Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period | Pulmonary Embolism | 0 Participants |
| Dabigatran 150mg | Number of Participants With Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period | death | 0 Participants |
| Dabigatran 150mg | Number of Participants With Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period | Total VTE and all-cause mortality | 3 Participants |
| Dabigatran 150mg | Number of Participants With Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period | asymptotic Deep Vein Thrombosis | 1 Participants |
| Enoxaparin | Number of Participants With Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period | asymptotic Deep Vein Thrombosis | 0 Participants |
| Enoxaparin | Number of Participants With Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period | Total VTE and all-cause mortality | 2 Participants |
| Enoxaparin | Number of Participants With Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period | symptotic Deep Vein Thrombosis | 0 Participants |
| Enoxaparin | Number of Participants With Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period | death | 2 Participants |
| Enoxaparin | Number of Participants With Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period | Pulmonary Embolism | 0 Participants |
Secondary
Volume of Blood Loss
Volume of blood loss for treated and operated patients during surgery.
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dabigatran 220mg | Volume of Blood Loss | 187 mL | Standard Deviation 258 |
| Dabigatran 150mg | Volume of Blood Loss | 190 mL | Standard Deviation 250 |
| Enoxaparin | Volume of Blood Loss | 191 mL | Standard Deviation 254 |