search
Back to results

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

Primary Purpose

Prophylaxis of Deep Vein Thrombosis

Status
Recruiting
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
r-Hirudin
Sponsored by
MinaPharm Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prophylaxis of Deep Vein Thrombosis focused on measuring r-Hirudin, Thrombexx, post-operative, prophylaxis, DVT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Alexandria UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

r-Hirudin

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
Adverse events
Recording serious adverse events (SAE)/ adverse events (AE) during the study duration.

Full Information

First Posted
April 5, 2023
Last Updated
April 26, 2023
Sponsor
MinaPharm Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT05847205
Brief Title
Study Evaluation of Recombinant Hirudin in Prophylaxis of Post-Operative Deep Vein Thrombosis
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 24, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MinaPharm Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prophylaxis of Deep Vein Thrombosis
Keywords
r-Hirudin, Thrombexx, post-operative, prophylaxis, DVT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Prospective, Single arm, single-center
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
r-Hirudin
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
r-Hirudin
Other Intervention Name(s)
Thrombexx
Intervention Description
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.
Primary Outcome Measure Information:
Title
new onset symptomatic thrombosis
Description
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.
Time Frame
up to 15 days post operative
Secondary Outcome Measure Information:
Title
Major bleeding
Description
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
Time Frame
up to 12 hours after surgery
Title
Adverse events
Description
Recording serious adverse events (SAE)/ adverse events (AE) during the study duration.
Time Frame
up to 15 days post operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ayman Dr Soliman, PhD
Phone
+20 100 1796219
Email
ssssoliman@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Abdalla Dr Hamad, PhD
Phone
+20 111 1056406
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayman Dr Soliman, PhD
Organizational Affiliation
Alexandria University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alexandria University
City
Alexandria
ZIP/Postal Code
003
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ayman Dr Soliman, PhD
Phone
+20 100 1796219
First Name & Middle Initial & Last Name & Degree
Abdalla Dr Soliman, PhD
Phone
+20 111 1056406

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs