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

Sponsor

MinaPharm Pharmaceuticals (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05847205

Collaborator

(none)

100

Enrollment

Location

Arm

13.2

Anticipated Duration (Months)

7.6

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Prophylaxis of Deep Vein Thrombosis	Drug: r-Hirudin	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Prospective, Single arm, single-centerProspective, Single arm, single-center

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Nov 24, 2022

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

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

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

Other Names:

Thrombexx

Outcome Measures

Primary Outcome Measures

new onset symptomatic thrombosis [up to 15 days post operative]
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 Outcome Measures

Major bleeding [up to 12 hours after surgery]
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
Adverse events [up to 15 days post operative]
Recording serious adverse events (SAE)/ adverse events (AE) during the study duration.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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