From the FDA Drug Label
In patients undergoing hip fracture, hip replacement, or knee replacement surgery, the recommended dose of fondaparinux sodium injection is 2.5 mg administered by subcutaneous injection once daily after hemostasis has been established. The usual duration of therapy is 5 to 9 days; up to 11 days of therapy was administered in clinical trials In patients undergoing hip fracture surgery, an extended prophylaxis course of up to 24 additional days is recommended.
The recommended thromboprophylaxis in patients with thrombophilia (blood clotting disorder) undergoing fracture surgery is fondaparinux sodium 2.5 mg administered by subcutaneous injection once daily after hemostasis has been established, for a duration of 5 to 9 days, with an option for extended prophylaxis up to 24 additional days in patients undergoing hip fracture surgery 1, 1.
- Key points:
- Dose: 2.5 mg once daily
- Duration: 5 to 9 days, with possible extension up to 24 additional days
- Administration: Subcutaneous injection after hemostasis has been established
- Important considerations:
- Bleeding risk: Increased in patients with renal impairment, low body weight, or concomitant use of other anticoagulants
- Monitoring: Regular complete blood counts, serum creatinine level, and stool occult blood tests are recommended 1
From the Research
Patients with thrombophilia undergoing fracture surgery should receive low molecular weight heparin (LMWH) such as enoxaparin 30mg twice daily for thromboprophylaxis, as it has been shown to be noninferior to LMWH in preventing death and is associated with low incidences of deep-vein thrombosis and pulmonary embolism, according to the most recent study 2.
Thromboprophylaxis Recommendations
The following points highlight the key recommendations for thromboprophylaxis in patients with thrombophilia undergoing fracture surgery:
- LMWH, such as enoxaparin, is recommended for thromboprophylaxis in these patients, starting 12-24 hours after surgery and continuing for at least 2-4 weeks, or until full mobilization.
- For patients with severe thrombophilia, consider higher prophylactic doses or therapeutic anticoagulation with enoxaparin 1mg/kg twice daily.
- Mechanical prophylaxis with intermittent pneumatic compression devices should be used in conjunction with pharmacological methods when possible.
- For patients already on long-term anticoagulation with warfarin, bridge therapy is necessary, stopping warfarin 5 days pre-operatively, using LMWH until surgery, and resuming warfarin postoperatively when hemostasis is adequate.
- Direct oral anticoagulants (DOACs) like rivaroxaban or apixaban may be considered for extended prophylaxis after initial LMWH therapy, as supported by studies such as 3.
Rationale for Recommendations
The enhanced prophylaxis is necessary because thrombophilia creates a hypercoagulable state through various mechanisms, including factor V Leiden mutation, prothrombin gene mutations, or deficiencies in natural anticoagulants, which, when combined with the additional prothrombotic state induced by trauma and surgery, creates a multiplicative risk for VTE complications, as discussed in 4 and 5.
Key Considerations
When making decisions about thromboprophylaxis, it is essential to consider the individual patient's risk factors, including the type of surgery, presence of additional risk factors, and history of VTE, as emphasized in 6 and 3.