Prophylaxis of Deep Vein Thrombosis
Conditions
Keywords
r-Hirudin, Thrombexx, post-operative, prophylaxis, DVT
Brief summary
This study aims to evaluate the efficacy and safety of r-Hirudin RB variant 15 mg in DVT prophylaxis post major orthopedic operations
Detailed description
Prospective, Single arm, single-center Phase IV 100 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. Patients undergoing major orthopedic operations For Events of Deep Vein Thrombosis (DVT) within 15 days post-op.) All of the patients underwent Routine bilateral compression Doppler. For Clinical PE (Pulmonary Embolism) Events from Day of surgery and During Hospitalization period or end of study Clinical PE events PE (Pulmonary Embolism) events were confirmed by spiral CT. For follow up: APTT should be done before the first dose then after 4 & 8 hours of the first dose, then on days 1,8,15 post operatively. Enrolment period: 3 months duration Follow-up duration: Follow-up per patient will be for a period of 15 days Primary endpoint: • Primary end points included new onset symptomatic thrombosis requiring medical or surgical intervention or death due to thrombosis defined as fatal PE, ischemic stroke, mesenteric thrombosis, or myocardial infarction Secondary endpoint: * The Secondary end point of major bleeding is defined as clinically evident hemorrhage associated with a hemoglobin decrease ≥ 2 g/dL that leads to a transfusion of ≥2 units of whole blood or packed red cells outside of the perioperative period (time from the start of the surgery or procedure and up to 12 hours after), or hemorrhage that is intracranial, retroperitoneal, or into a prosthetic joint. * Recording serious adverse events (SAE)/ adverse events (AE) during the study duration.
Interventions
DRUGr-Hirudin
100 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.
Sponsors
MinaPharm Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, Single arm, single-center
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| new onset symptomatic thrombosis | up to 15 days post operative | Primary end points included new onset symptomatic thrombosis requiring medical or surgical intervention or death due to thrombosis defined as fatal PE, ischemic stroke, mesenteric thrombosis, or myocardial infarction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major bleeding | up to 12 hours after surgery | The Secondary end point of major bleeding is defined as clinically evident hemorrhage associated with ahemoglobin decrease ≥ 2 g/dL that leads to a transfusion of ≥2 units of whole blood or packed red cells outside of the perioperative period |
| Adverse events | up to 15 days post operative | Recording serious adverse events (SAE)/ adverse events (AE) during the study duration. |
Countries
Egypt
Contacts
Primary ContactAyman Dr Soliman, PhD
Backup ContactAbdalla Dr Hamad, PhD
Outcome results
None listed