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

Phase

Condition

Venous Thrombosis

Thrombosis

Vascular Diseases

Treatment

r-Hirudin

Clinical Study ID

NCT05847205

THRIVE-DVT

Ages > 18
All Genders
Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

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 studymedication use unless strictly indicated. These agents include medications such as:anticoagulants, thrombolytics, non-steroidal anti- inflammatory agents (includingKetorolac tromethamine), preparations containing aspirin, systemic salicylates,ticlopidine, dextran 40, clopidogrel, other anti-platelet agents includingglycoprotein IIb/IIIa antagonists or systemic glucocorticoids.

Exclusion

Exclusion Criteria:

Significant bleeding injury such as solid organ laceration or intracranial bleed atdiscretion 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 discretionof the treating clinician
Required therapeutic anticoagulation for atrial fibrillation, prior VTE, or mechanicalheart 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

Study Design

r-Hirudin

November 24, 2022

December 31, 2023

Study 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.

Connect with a study center

Alexandria University
Alexandria, 003
Egypt
Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.