Study Evaluation of Recombinant Hirudin in Prophylaxis of Post-Operative Deep Vein Thrombosis (Thromb-001)
Prophylaxis of Deep Vein Thrombosis
About this trial
This is an interventional treatment trial for Prophylaxis of Deep Vein Thrombosis focused on measuring r-Hirudin, Thrombexx, post-operative, prophylaxis, DVT
Eligibility Criteria
Inclusion Criteria: 18 years of age or older Body Weight >60 kg Patients undergoing major orthopedic operations Patients ready to sign informed consent form (ICF) Patients should discontinue any agents that affect haemostasis prior to the study medication use unless strictly indicated. These agents include medications such as: anticoagulants, thrombolytics, non-steroidal anti- inflammatory agents (including Ketorolac tromethamine), preparations containing aspirin, systemic salicylates, ticlopidine, dextran 40, clopidogrel, other anti-platelet agents including glycoprotein IIb/IIIa antagonists or systemic glucocorticoids. Exclusion Criteria: Significant bleeding injury such as solid organ laceration or intracranial bleed at discretion of attending physician Hypersensitivity to Hirudin or prior documented Allergy to its components Pregnant or breast feeding Hemorrhagic stroke in preceding 3 months abnormal baseline coagulation characterized by an INR >1.4, obtained at the discretion of the treating clinician Required therapeutic anticoagulation for atrial fibrillation, prior VTE, or mechanical heart valve Patients with a history of coagulation disorder Treatment with concomitant anti-platelet agent other than aspirin 326 mg or more daily (Platelet count< 100X109 /dl) Active bleeding Subjects with a life expectancy less than 1 month
Sites / Locations
- Alexandria UniversityRecruiting
Arms of the Study
Arm 1
Experimental
r-Hirudin
Patients will be treated with r-Hirudin (Thrombexx) for a total of 15 days beginning with 15 mg BID s.c starting 6 hours after surgery or upon adequate hemostasis and continued until end of study.