NCT05847205

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

A Prospective, Single- Center, Phase IV, Interventional, Single Arm Trial for the Evaluation of Subcutaneous Recombinant Hirudin 15 mg (RB Variant) in Prophylaxis of Deep Vein Thrombosis (DVT) Post Major Orthopedic Operations

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: MinaPharm Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Prophylaxis of Deep Vein Thrombosis

Interventions

Type	Name	Description
DRUG	r-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.

Timeline

• Start date: 2022-11-24
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2023-05-06
• Last updated: 2023-05-06

Locations

1 site across 1 country: Egypt