Primary Total Hip and Knee Arthroplasty
Conditions
Keywords
Hip, Knee, Arthroplasty, venous thromboembolic events, blood loss
Brief summary
This is a prospective, randomized study from pre-surgery to 6 weeks post-surgery designed to detect changes in coagulability following elective total knee and hip arthroplasty. Patients will be randomized to one of the two standard prophylaxis treatments used at Sinai Hospital: 1. Arixtra (2.5 mg SQ/QD) subcutaneous injection daily for 2 weeks followed by aspirin 325 mg for 5 weeks, or 2. Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel) for 2 weeks with concomitant Aspirin 325 mg daily for 5 weeks.
Interventions
DRUGArixtra
Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel)
DRUGAspirin
Sponsors
Haemonetics Corporation
LifeBridge Health
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Men or women age ≥ 18 years old 2. Total knee or total hip arthroplasty planned in the 60 days following study enrollment
Exclusion criteria
1. Pre-existing anti-coagulant therapy (Heparin, Lovenox, Arixtra, Warfarin, Xarelto, and all other non-mentioned anticoagulants) on admission 2. History of bleeding diathesis 3. Known active malignancy 4. Prothrombin time \>1.5 x control 5. Platelet count \< 100,000/mm3, hematocrit \< 30%, creatinine clearance \<30 mL/min 6. Immunosuppression, e.g., human immunodeficiency virus (HIV) infection, Chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, Bacterial endocarditis 7. Major surgery within past 3 months of enrollment 8. Patients requiring bilateral arthroplasty 9. Body weight \<50 kg (venous thromboembolism prophylaxis only) 10. Unable to return to site for follow-up visit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Loss | 6 weeks | requiring transfusion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Deep Vein Thrombosis | 6 weeks | verified by ultrasound |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arixtra Arm Arixtra (2.5 mg SQ/QD) subcutaneous injection daily for 2 weeks followed by aspirin 325 mg for 5 weeks
Arixtra
Aspirin | 27 |
| Pneumatic Compression Stockings Arm Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel) for 2 weeks with concomitant Aspirin 325 mg daily for 5 weeks.
Pneumatic compression stockings: Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel)
Aspirin | 22 |
| Total | 49 |
Baseline characteristics
| Characteristic | Arixtra Arm | Pneumatic Compression Stockings Arm | Total |
|---|---|---|---|
| Age, Continuous | 59 years STANDARD_DEVIATION 13 | 58 years STANDARD_DEVIATION 14 | 58 years STANDARD_DEVIATION 14 |
| Sex: Female, Male Female | 17 Participants | 11 Participants | 28 Participants |
| Sex: Female, Male Male | 10 Participants | 11 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Blood Loss
requiring transfusion
Time frame: 6 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arixtra Arm | Blood Loss | 6 participants |
| Pneumatic Compression Stockings Arm | Blood Loss | 1 participants |
Secondary
Deep Vein Thrombosis
verified by ultrasound
Time frame: 6 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arixtra Arm | Deep Vein Thrombosis | 0 participants |
| Pneumatic Compression Stockings Arm | Deep Vein Thrombosis | 0 participants |