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

NCT05847205 | Unknown Phase 4 DMC

• 1 other identifier: THRIVE-DVT
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Prophylaxis of Deep Vein Thrombosis

Keywords

r-Hirudin; Thrombexx; post-operative; prophylaxis; DVT

Outcome Measures

Primary Outcomes (1)

• new onset symptomatic thrombosis

  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.

  up to 15 days post operative

Secondary Outcomes (2)

• Major bleeding

  up to 12 hours after surgery

• Adverse events

  up to 15 days post operative

Study Arms (1)

r-Hirudin

EXPERIMENTAL

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.

Drug: r-Hirudin

Interventions

r-Hirudin 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.

Also known as: Thrombexx

r-Hirudin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• MinaPharm Pharmaceuticals: lead

Study Sites (1)

Alexandria University

Alexandria, 003, Egypt

RECRUITING

Study Officials

• Ayman Dr Soliman, PhD

  Alexandria University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayman Dr Soliman, PhD

CONTACT

+20 100 1796219; ssssoliman@gmail.com

Abdalla Dr Hamad, PhD

CONTACT

+20 111 1056406

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, Single arm, single-center

Study Record Dates

• First Submitted: April 5, 2023
• First Posted: May 6, 2023
• Study Start: November 24, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 6, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)