Use of Hirulog in the prevention of venous thrombosis after major hip or knee surgery.
Key result
Hirulog at 1.0 mg/kg every 8 hours significantly reduced total deep vein thrombosis compared to pooled lower doses (17% vs 43%; P=0.010) after major hip or knee surgery.
Why the study?
Does postoperative subcutaneous Hirulog prevent deep vein thrombosis in patients undergoing major hip or knee surgery?
Population
222 unselected patients undergoing major hip or knee surgery in tertiary-care, university-affiliated hospitals
Comparison
Subcutaneous Hirulog initiated postoperatively… vs Lower dose regimens of Hirulog
Design
Other, open-label
Follow-up
until discharge (up to 11+ days)
Authors
Discussion
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Member takes
Implication
Supports further development of Hirulog for DVT prophylaxis after orthopedic surgery; leaves open need for confirmatory phase 3 trials.
Structured PICO
Does postoperative subcutaneous Hirulog prevent deep vein thrombosis in patients undergoing major hip or knee surgery?
P
Population
222 unselected patients undergoing major hip or knee surgery evaluated for the prevention of deep vein thrombosis using a dose-escalating regimen.
I
Intervention
Subcutaneous Hirulog initiated postoperatively in five dose-escalating regimens (0.3 mg/kg q12h, 0.6 mg/kg q12h, 1.0 mg/kg q12h for 3 days followed by 0.6 mg/kg q12h for up to 11 days, 1.0 mg/kg q12h, and 1.0 mg/kg q8h)
C
Comparator
Lower dose regimens of Hirulog (dose-escalating design)
O
Outcome
Deep vein thrombosis (total and proximal) evaluated by mandatory bilateral venography before discharge, and symptomatic pulmonary embolismsurrogate
Main Result
Absolute Event Rate: 17% vs 43%
p-value: p=0.010
Subcutaneous Hirulog at 1.0 mg/kg every 8 hours appears efficacious and safe for preventing DVT after major orthopedic surgery.
Cite This Study
Ginsberg et al. (1994) studied Deep vein thrombosis prevention after orthopedic surgery (n=222). Hirulog vs. Pooled lower-dose Hirulog regimens was evaluated on Total deep vein thrombosis (DVT) (p=0.010). Hirulog at 1.0 mg/kg every 8 hours significantly reduced total deep vein thrombosis compared to pooled lower doses (17% vs 43%; P=0.010) after major hip or knee surgery.