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

NCT ID: NCT05847205

Last Updated: 2023-05-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-24
• Study Completion Date: 2023-12-31

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.

Conditions

Prophylaxis of Deep Vein Thrombosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

r-Hirudin

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.

Group Type: EXPERIMENTAL

r-Hirudin

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Thrombexx

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

MinaPharm Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ayman Dr Soliman, PhD

Role: PRINCIPAL_INVESTIGATOR

Alexandria University

Locations

Alexandria University

Alexandria, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Ayman Dr Soliman, PhD

Role: CONTACT

ssssoliman@gmail.com

+20 100 1796219

Abdalla Dr Hamad, PhD

Role: CONTACT

+20 111 1056406

Facility Contacts

Ayman Dr Soliman, PhD

Role: primary

+20 100 1796219

Abdalla Dr Soliman, PhD

Role: backup

+20 111 1056406

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

THRIVE-DVT

Identifier Type: -

Identifier Source: org_study_id