Study Evaluation of Recombinant Hirudin in Prophylaxis of Post-Operative Deep Vein Thrombosis

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to evaluate the efficacy and safety of r-Hirudin RB variant 15 mg in DVT prophylaxis post major orthopedic operations

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: MinaPharm Pharmaceuticals
• Treatments: Hirudins

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