Arthroplasty, Replacement, Hip, Thromboembolism
Conditions
Brief summary
The objective of this study is to determine the comparative efficacy and safety of two oral regimens of dabigatran etexilate, compared to a standard subcutaneous regimen of enoxaparin, in prevention of venous thromboembolism in patients with primary elective total hip replacement surgery.
Interventions
DRUGdabigatran etexilate
daily dose 150 mg once daily, half a dose on the day of surgery
DRUGenoxaparin
40 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, elective total hip replacement * Written Informed Consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period | First administration until 31-38 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 |
|---|---|---|
| Proximal Deep Vein Thrombosis During Treatment Period | First administration until 31-38 days | Proximal Deep Vein Thrombosis as adjudicated by the VTE events committee |
| Total Deep Vein Thrombosis During Treatment Period | First administration until 31-38 days | Total Deep Vein Thrombosis as adjudicated by the VTE events committee |
| Symptomatic Deep Vein Thrombosis During Treatment Period | First administration until 31-38 days | Symptomatic Deep Vein Thrombosis, confirmed by venous compression ultrasound, venography or autopsy, and as adjudicated by the VTE events committee |
| Pulmonary Embolism During Treatment Period | First administration until 31-38 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 |
| Death During Treatment Period | First administration until 31-38 days | All cause death, as adjudicated by the VTE events committee |
| Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period | First administration until 31-38 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 31-38 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. |
| Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period | end of treatment to day 91±7 | 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, Norway, 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 28 - 35 days. The study period is from first administration of study medication until day 84 - 91.
Pre-assignment details
Whilst 3494 patients were enrolled/randomised to treatment prior to surgery in this trial, only 3463 started treatment. Therefore, 31 patients were randomised but not treated (treatment was planned to start post surgery).
Participants by arm
| Arm | Count |
|---|---|
| Dabigatran 220mg Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes. | 1,146 |
| Dabigatran 150mg Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes. | 1,163 |
| Enoxaparin Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules. | 1,154 |
| Total | 3,463 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 23 | 29 | 31 |
| Overall Study | Lost to Follow-up | 13 | 4 | 15 |
| Overall Study | Other | 22 | 24 | 30 |
| Overall Study | Protocol Violation | 16 | 11 | 11 |
| Overall Study | Withdrawal by Subject | 43 | 41 | 37 |
| Treatment | Adverse Event | 77 | 89 | 68 |
| Treatment | Lost to Follow-up | 0 | 2 | 1 |
| Treatment | Other | 23 | 29 | 31 |
| Treatment | Protocol Violation | 8 | 11 | 11 |
| Treatment | Withdrawal by Subject | 25 | 20 | 22 |
Baseline characteristics
| Characteristic | Dabigatran 220mg | Dabigatran 150mg | Enoxaparin | Total |
|---|---|---|---|---|
| Age, Continuous | 64.6 Years STANDARD_DEVIATION 10.4 | 63.4 Years STANDARD_DEVIATION 11.1 | 63.8 Years STANDARD_DEVIATION 10.8 | 63.9 Years STANDARD_DEVIATION 10.8 |
| Body Mass Index N=(1146;1163;1151;3460) | 27.7 kg/m^2 STANDARD_DEVIATION 4.6 | 27.8 kg/m^2 STANDARD_DEVIATION 4.6 | 27.5 kg/m^2 STANDARD_DEVIATION 4.3 | 27.7 kg/m^2 STANDARD_DEVIATION 4.5 |
| Sex: Female, Male Female | 636 Participants | 667 Participants | 651 Participants | 1954 Participants |
| Sex: Female, Male Male | 510 Participants | 496 Participants | 503 Participants | 1509 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 | 620 / 1,146 | 642 / 1,163 | 648 / 1,154 |
| serious Total, serious adverse events | 89 / 1,146 | 91 / 1,163 | 82 / 1,154 |
Outcome results
Primary
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 31-38 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 symptomatic Deep Vein Thrombosis, Pulmonary Embolism, or had died)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran 220mg | Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period | 53 Participants |
| Dabigatran 150mg | Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period | 75 Participants |
| Enoxaparin | Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period | 60 Participants |
Comparison: Risk difference versus Enoxaparinp-value: 0.564895% CI: [-2.9, 1.6]Normal approximation
Comparison: Risk difference versus Enoxaparinp-value: 0.133995% CI: [-0.6, 4.4]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 | 517 participants |
| Dabigatran 220mg | Blood Transfusion | Patients with >=1 non-autologous transfusions | 259 participants |
| Dabigatran 150mg | Blood Transfusion | Patients with >=1 transfusions | 531 participants |
| Dabigatran 150mg | Blood Transfusion | Patients with >=1 non-autologous transfusions | 266 participants |
| Enoxaparin | Blood Transfusion | Patients with >=1 transfusions | 542 participants |
| Enoxaparin | Blood Transfusion | Patients with >=1 non-autologous transfusions | 286 participants |
Secondary
Death During Treatment Period
All cause death, as adjudicated by the VTE events committee
Time frame: First administration until 31-38 days
Population: Full Analysis Set - op (all patients who are treated and operated)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran 220mg | Death During Treatment Period | 3 Participants |
| Dabigatran 150mg | Death During Treatment Period | 3 Participants |
| Enoxaparin | Death During Treatment Period | 0 Participants |
Comparison: Comparison versus Enoxaparinp-value: 0.124Fisher Exact
Comparison: Comparison versus Enoxaparinp-value: 0.2497Fisher Exact
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=(1103;1097;1103) | 11 participants |
| Dabigatran 220mg | Laboratory Analyses | AST decrease N=(1103;1097;1103) | 0 participants |
| Dabigatran 220mg | Laboratory Analyses | ALT increase N=(1103;1098;1103) | 28 participants |
| Dabigatran 220mg | Laboratory Analyses | ALT decrease N=(1103;1098;1103) | 0 participants |
| Dabigatran 220mg | Laboratory Analyses | Bilirubin increase N=(1102;1094;1102) | 25 participants |
| Dabigatran 220mg | Laboratory Analyses | Bilirubin decrease N=(1102;1094;1102) | 0 participants |
| Dabigatran 150mg | Laboratory Analyses | Bilirubin decrease N=(1102;1094;1102) | 0 participants |
| Dabigatran 150mg | Laboratory Analyses | AST increase N=(1103;1097;1103) | 16 participants |
| Dabigatran 150mg | Laboratory Analyses | ALT decrease N=(1103;1098;1103) | 0 participants |
| Dabigatran 150mg | Laboratory Analyses | Bilirubin increase N=(1102;1094;1102) | 24 participants |
| Dabigatran 150mg | Laboratory Analyses | AST decrease N=(1103;1097;1103) | 0 participants |
| Dabigatran 150mg | Laboratory Analyses | ALT increase N=(1103;1098;1103) | 29 participants |
| Enoxaparin | Laboratory Analyses | AST decrease N=(1103;1097;1103) | 0 participants |
| Enoxaparin | Laboratory Analyses | ALT increase N=(1103;1098;1103) | 59 participants |
| Enoxaparin | Laboratory Analyses | Bilirubin decrease N=(1102;1094;1102) | 0 participants |
| Enoxaparin | Laboratory Analyses | ALT decrease N=(1103;1098;1103) | 0 participants |
| Enoxaparin | Laboratory Analyses | AST increase N=(1103;1097;1103) | 29 participants |
| Enoxaparin | Laboratory Analyses | Bilirubin increase N=(1102;1094;1102) | 34 participants |
Secondary
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 31-38 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 | Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period | 28 Participants |
| Dabigatran 150mg | Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period | 38 Participants |
| Enoxaparin | Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period | 36 Participants |
Comparison: Risk difference versus Enoxaparinp-value: 0.325695% CI: [-2.5, 0.8]Normal approximation
Comparison: Risk difference versus Enoxaparinp-value: 0.705295% CI: [-1.5, 2.2]Normal approximation
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 31-38 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 | Major | 23 Participants |
| Dabigatran 220mg | Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period | Clinical relevant | 48 Participants |
| Dabigatran 220mg | Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period | Minor | 70 Participants |
| Dabigatran 220mg | Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period | None | 1005 Participants |
| Dabigatran 150mg | Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period | None | 1021 Participants |
| Dabigatran 150mg | Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period | Major | 15 Participants |
| Dabigatran 150mg | Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period | Minor | 72 Participants |
| Dabigatran 150mg | Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period | Clinical relevant | 55 Participants |
| Enoxaparin | Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period | None | 1022 Participants |
| Enoxaparin | Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period | Clinical relevant | 40 Participants |
| Enoxaparin | Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period | Minor | 74 Participants |
| Enoxaparin | Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period | Major | 18 Participants |
Comparison: Comparison versus Enoxaparinp-value: 0.4352Fisher Exact
Comparison: Comparison versus Enoxaparinp-value: 0.6037Fisher Exact
Secondary
Proximal Deep Vein Thrombosis During Treatment Period
Proximal Deep Vein Thrombosis as adjudicated by the VTE events committee
Time frame: First administration until 31-38 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 | Proximal Deep Vein Thrombosis During Treatment Period | 23 Participants |
| Dabigatran 150mg | Proximal Deep Vein Thrombosis During Treatment Period | 35 Participants |
| Enoxaparin | Proximal Deep Vein Thrombosis During Treatment Period | 33 Participants |
Comparison: Risk difference versus Enoxaparinp-value: 0.186395% CI: [-2.7, 0.5]Normal approximation
Comparison: Risk difference versus Enoxaparinp-value: 0.70295% CI: [-1.4, 2.1]Normal approximation
Secondary
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 31-38 days
Population: Full Analysis Set - op (all patients who are treated and operated)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran 220mg | Pulmonary Embolism During Treatment Period | 5 Participants |
| Dabigatran 150mg | Pulmonary Embolism During Treatment Period | 1 Participants |
| Enoxaparin | Pulmonary Embolism During Treatment Period | 3 Participants |
Comparison: Comparison versus Enoxaparinp-value: 0.5062Fisher Exact
Comparison: Comparison versus Enoxaparinp-value: 0.3717Fisher Exact
Secondary
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 31-38 days
Population: Full Analysis Set - op (all patients who are treated and operated)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran 220mg | Symptomatic Deep Vein Thrombosis During Treatment Period | 6 Participants |
| Dabigatran 150mg | Symptomatic Deep Vein Thrombosis During Treatment Period | 9 Participants |
| Enoxaparin | Symptomatic Deep Vein Thrombosis During Treatment Period | 1 Participants |
Comparison: Comparison versus Enoxaparinp-value: 0.0694Fisher Exact
Comparison: Comparison versus Enoxaparinp-value: 0.0212Fisher Exact
Secondary
Total Deep Vein Thrombosis During Treatment Period
Total Deep Vein Thrombosis as adjudicated by the VTE events committee
Time frame: First administration until 31-38 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 | Total Deep Vein Thrombosis During Treatment Period | 46 Participants |
| Dabigatran 150mg | Total Deep Vein Thrombosis During Treatment Period | 72 Participants |
| Enoxaparin | Total Deep Vein Thrombosis During Treatment Period | 57 Participants |
Comparison: Risk difference versus Enoxaparinp-value: 0.317395% CI: [-3.3, 1.1]Normal approximation
Comparison: Risk difference versus Enoxaparinp-value: 0.127495% CI: [-0.5, 4.3]Normal approximation
Secondary
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: end of treatment to day 91±7
Population: Patients with any data available during follow-up
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dabigatran 220mg | Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period | Pulmonary Embolism | 0 Participants |
| Dabigatran 220mg | Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period | symptotic Deep Vein Thrombosis | 1 Participants |
| Dabigatran 220mg | Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period | Total VTE and all-cause mortality | 1 Participants |
| Dabigatran 220mg | Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period | asymptotic Deep Vein Thrombosis | 0 Participants |
| Dabigatran 220mg | Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period | death | 0 Participants |
| Dabigatran 150mg | Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period | symptotic Deep Vein Thrombosis | 1 Participants |
| Dabigatran 150mg | Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period | Total VTE and all-cause mortality | 4 Participants |
| Dabigatran 150mg | Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period | asymptotic Deep Vein Thrombosis | 1 Participants |
| Dabigatran 150mg | Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period | Pulmonary Embolism | 0 Participants |
| Dabigatran 150mg | Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period | death | 2 Participants |
| Enoxaparin | Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period | death | 1 Participants |
| Enoxaparin | Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period | Pulmonary Embolism | 1 Participants |
| Enoxaparin | Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period | Total VTE and all-cause mortality | 5 Participants |
| Enoxaparin | Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period | symptotic Deep Vein Thrombosis | 0 Participants |
| Enoxaparin | Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period | asymptotic Deep Vein Thrombosis | 3 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 | 457 mL | Standard Deviation 304 |
| Dabigatran 150mg | Volume of Blood Loss | 435 mL | Standard Deviation 271 |
| Enoxaparin | Volume of Blood Loss | 463 mL | Standard Deviation 291 |