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direct antithrombins in thrombosis prevention for orthopedic surgery , clinical trials results

ximelagatran versus Dalteparin
METHRO I, 2002
Melagatran 1–4 mg s.c. immediately before surgery, melagatran at 20.00 hours, then ximelagatran 6–24 mg orally b.d. for 6–9 days
versus
Dalteparin 5000 IU o.d., started evening before surgery for 6–9 days
adults undergoing hip or knee replacementopen
Follow-up duration: 6–9 days
Swedish
METHRO II, 2002
Melagatran 1–3 mg s.c. immediately before surgery,melagatran same day, then ximelagatran 8–24 mg orally b.d. for 7–10 days
versus
Dalteparin 5000 IU o.d., started evening before surgery for 7–10 days
undergoing hip or knee replacementdouble-blind
Follow-up duration: 7–10 days
ximelagatran versus Enoxaparin
Platinum (Colwell), 2003
Ximelagatran 24 mg orally b.d., starting at least 12 h after surgery for 7–12 days
versus
Enoxaparin 30 mg s.c. b.d.,starting at least 12 h after surgery for 7–12 days
adults undergoing hip replacementdouble-blind
Follow-up duration: 7–12 days
USA, Canada, Israel, Mexico,Argentina, South Africa
METHRO III, 2002
Melagatran 3 mg s.c. 4–12h after surgery, then ximelagatran24 mg orally b.d. for 7–10 days
versus
Enoxaparin 40 mg s.c. o.d. 12 h before surgery for 7–10 days
hip or knee replacementdouble-blind
Follow-up duration: 8–11 days
Europe, South Africa
Phase II (Heit), 2001
Ximelagatran 8, 12, 18 or 24 mgorally b.d., at least 12 h after surgery for 6–12 days
versus
Enoxaparin 30 mg s.c. b.d.,starting at least 12 h after surgery for 6–12 days
adults (age>18 years and weight at least 40 kg) undergoing knee replacementsdouble-blind
Follow-up duration: 6–12 days
North American
EXPRESS, 2003
Melagatran 2 mg s.c. up to 30 min before surgery, then melagatran 3 mg at least 8 hafter surgery, then ximelagatran 24 mg orally b.d. for 8–11 days
versus
Enoxaparin 40 mg s.c. o.d.,starting 12 h before surgery for 8–11 days
hip or knee replacementdouble-blind
Follow-up duration: 8–11 days
Europe

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