Study Evaluation of Recombinant Hirudin in Prophylaxis of Post-Operative Deep Vein Thrombosis (Thromb-001)

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

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

Study Overview

• Status: Recruiting
• Conditions: Prophylaxis of Deep Vein Thrombosis
• Intervention / Treatment: Drug: r-Hirudin

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ayman Dr Soliman, PhD; Phone Number: +20 100 1796219; Email: ssssoliman@gmail.com
• Study Contact Backup: Name: Abdalla Dr Hamad, PhD; Phone Number: +20 111 1056406

Study Locations

• Egypt
  • Alexandria, Egypt, 003
    • Recruiting
    • Alexandria University
    • Contact: Ayman Dr Soliman, PhD; Phone Number: +20 100 1796219
    • Contact: Abdalla Dr Soliman, PhD; Phone Number: +20 111 1056406

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.; Other Names: Thrombexx

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major bleeding	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	up to 12 hours after surgery
Adverse events	Recording serious adverse events (SAE)/ adverse events (AE) during the study duration.	up to 15 days post operative

Collaborators and Investigators

• Sponsor: MinaPharm Pharmaceuticals
• Investigators: Principal Investigator: Ayman Dr Soliman, PhD, Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2022
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: April 5, 2023
• First Submitted That Met QC Criteria: April 26, 2023
• First Posted (Estimate): May 8, 2023

Study Record Updates

• Last Update Posted (Estimate): May 8, 2023
• Last Update Submitted That Met QC Criteria: April 26, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: prophylaxis; DVT; post-operative; Thrombexx; r-Hirudin
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Fibrinolytic Agents; Fibrin Modulating Agents; Protease Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Hirudins
• Other Study ID Numbers: THRIVE-DVT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No