Prophylaxis of Deep Vein ThrombosisPhase 4Thromb-001NCT05847205
Study Evaluation of Recombinant Hirudin in Prophylaxis of Post-Operative Deep Vein Thrombosis
A Phase 4 study testing r-Hirudin in people with Prophylaxis of Deep Vein Thrombosis, run by MinaPharm Pharmaceuticals at 1 site in Egypt.
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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prophylaxis of Deep Vein Thrombosis
- What is being tested?
- r-Hirudin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 24 Nov 2022to 31 Dec 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Abdalla Dr Hamad, PhD contact
Egypt1 site, 1 recruiting
- Recruiting
Alexandria University
Alexandria, 003
Ayman Dr Soliman, PhD, +20 100 1796219
Abdalla Dr Soliman, PhD, +20 111 1056406
About this study
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
This study aims to evaluate the efficacy and safety of r-Hirudin RB variant 15 mg in DVT prophylaxis post major orthopedic operations
Read the 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.
- Conditions
- Prophylaxis of Deep Vein Thrombosis
- Being tested
- r-Hirudin
- Keywords
- r-Hirudin, Thrombexx, post-operative, prophylaxis, DVT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
r-HirudinDrug
Also called Thrombexx
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: r-Hirudin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 15 days post operative
Secondary outcomes (2)
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
Measured: up to 12 hours after surgery
Adverse events
Recording serious adverse events (SAE)/ adverse events (AE) during the study duration.
Measured: up to 15 days post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start24 Nov 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prophylaxis of Deep Vein ThrombosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, Single arm, single-center
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MinaPharm Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ayman Dr Soliman, PhD, Principal investigator, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05847205
- Sponsor's protocol ID
- THRIVE-DVT
- Acronym
- Thromb-001
- Status last verified
- Apr 2023
- First submitted
- 5 Apr 2023
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05847205
- Acronym / sponsor ID
- Thromb-001 / THRIVE-DVT
- Conditions
- Prophylaxis of Deep Vein Thrombosis
- Keywords
- r-Hirudin, Thrombexx, post-operative, prophylaxis, DVT
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- MinaPharm PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 24 Nov 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, Single arm, single-center
| Arm | Type | Receives |
|---|---|---|
| r-Hirudin | Experimental | Drug: r-HirudinPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| r-HirudinAlso: Thrombexx100 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 |
Primary outcome
new onset symptomatic thrombosis
Time frame: 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.
2 secondary outcomes
Major bleeding
Time frame: up to 12 hours after surgery
Adverse events
Time frame: up to 15 days post operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abdalla Dr Hamad, PhD contact
Ayman Dr Soliman, PhD principal investigator
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing r-Hirudin in people with Prophylaxis of Deep Vein Thrombosis, run by MinaPharm Pharmaceuticals at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ayman Dr Soliman, PhD (+20 100 1796219, ssssoliman@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
new onset symptomatic thrombosis (time frame: up to 15 days post operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.