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

Prophylaxis of Deep Vein Thrombosis Clinical Trial

— Thromb-001  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05847205
• Other study ID #: THRIVE-DVT
• Status: Recruiting
• Phase: Phase 4
• Start date: November 24, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2023
• Source: MinaPharm Pharmaceuticals
• Contact: Ayman Dr Soliman, PhD
• Phone: +20 100 1796219
• Email: ssssoliman[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prophylaxis of Deep Vein Thrombosis
• Thrombosis
• Venous Thrombosis

Intervention

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.

Locations

Country	Name	City	State
Egypt	Alexandria University	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
MinaPharm Pharmaceuticals

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Adverse events	Recording serious adverse events (SAE)/ adverse events (AE) during the study duration.	up to 15 days post operative