Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2025-12-25 @ 3:13 AM
NCT ID:
NCT05847205
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05847205
Study Brief:
Protocol Section:
NCT05847205