Hepatic DiseasePhase 3PRIORITYNCT06153394
Prolonged Hypercoagulability Following Major Liver Resection for Malignancy
A Phase 3 study testing Redesca (enoxaparin sodium for injection) and Fragmin (dalteparin) in people with Hepatic Disease and Surgery-Complications, run by Western University, Canada at 1 site in Canada.
Trial summary
This clinical trial will investigate the ability of thromboelastrogrpahy (TEG®) to detect hypercoagulability after liver surgery and will examine the effect of extended thromboprophylaxis (medical treatment to prevent the development of blood clots inside blood vessels) in patients undergoing liver surgery for cancer… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatic Disease, Surgery-Complications, Hypercoagulability
- What is being tested?
- Redesca (enoxaparin sodium for injection) and Fragmin (dalteparin)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2024to 1 Feb 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older at the time of enrollment.
- Requiring major liver resection (>2 liver sections) for any oncologic indication.
- Requiring postoperative thromboprophylaxis will be included.
- Willing and able to perform subcutaneous injections according to the study protocol, or receive injections form a caregiver delegated by the participant.
Who cannot join
- Anyone below 18 years of age.
- Patients on current anticoagulant and/or antiplatelet therapy
- Patients with a history of thrombotic events
- Patients with a coagulation disorder.
- Patients with recognized thrombophilia.
- Patients who cannot understand/speak or read in English.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This clinical trial will investigate the ability of thromboelastrogrpahy (TEG®) to detect hypercoagulability after liver surgery and will examine the effect of extended thromboprophylaxis (medical treatment to prevent the development of blood clots inside blood vessels) in patients undergoing liver surgery for cancer treatment.
The liver plays a key role in regulating the process of blood clotting. As a result, blood clots are a major cause of complications and death following liver surgery. This is especially true in cancer patients who are at a higher risk of developing blood clots. Current methods for preventing clotting complications after liver surgery include conventional coagulation blood tests (CCTs) and anticoagulant drugs, such as low molecular weight heparins (LMWHs). Current LMWH treatment is prescribed for one month after surgery, but studies show that the risk of developing blood clots can last up to 3 months. Studies also show that CCTs may not be as effective in detecting clotting issues as more comprehensive testing systems, such as TEG. This study will randomize 50 participants to receive 90 days of thromboprophylaxis (using the LMWH Redesca) or the standard of care 30 days (using the LMWH Fragmin) after liver surgery. The medication will be given by injection, similar to a regular vaccine or an insulin injection. Participants will inject the medication every day, for 30 or 90 days, after surgery. Participants will also have their blood tested for clotting issues via TEG testing before surgery and on post-operative days 1,3,5,30 and 90. After surgery, participants will be monitored by their surgeon for clotting complications and 3 year disease-free survival.
- Conditions
- Hepatic Disease, Surgery-Complications, Hypercoagulability, Thrombosis
- Being tested
- Redesca (enoxaparin sodium for injection), Fragmin (dalteparin)
- Medical subject headings
- Digestive System Diseases, Thrombophilia, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Redesca (enoxaparin sodium for injection)Drug
Redesca is low molecular weight heparin and a biosimilar biologic drug (biosimilar) to Lovenox. Indications have been granted on the basis of similarity between Redesca and the reference biologic drug Lovenox. As such, Redesca (enoxaparin sodium) is indicated for thromboprophylaxis in patients undergoing high risk abdominal and colorectal surgeries. Doses are provided as self-administered subcutaneous injections using a pre-filled syringe with a protective shield.
Fragmin (dalteparin)Drug
Fragmin is a low molecular weight heparin indicated for thromboprophylaxis in patients undergoing high risk abdominal and colorectal surgeries. Doses are provided as self-administered subcutaneous injections using a pre-filled syringe with a protective shield. Our institution uses this drug for standard of care thromboprophylaxis (30 days) in this patient population.
| Study group | Role | What they receive |
|---|---|---|
| Redesca | Experimental | Patients in the extended thromboprophylaxis group will receive Redesca (enoxaparin sodium for injection) (40mg) once a day, starting on the day of surgery, for 90 days postoperatively. Receives: Drug: Redesca (enoxaparin sodium for injection) |
| Fragmin | Active comparator | Patients in the standard of care group will receive Fragmin (daletparin) (5,000 I.U) once a day, starting on the day or surgery, for 30 days postoperatively. Receives: Drug: Fragmin (dalteparin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number pf participants with hypercoagulability identified via TEG testing
All participants will have postoperative TEG testing performed for the detection of hypercoagulability.
Measured: Preoperatively (with pre-admission blood work) through to 90 days postoperatively
Secondary outcomes (2)
Thrombotic Events
Determining the occurrence of postoperative venous thrombotic events between treatment groups
Measured: Up to 6 months postoperatively
Disease Free Survival
Comparing disease free survival (DFS) rates between treatment groups
Measured: Up to 3 years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study start1 Jun 2024 (estimated)
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic DiseaseStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This will be a phase III pilot trial where 50 participants will be randomized 1:1 to receive extended duration thromboprophylaxis via Redesca or standard of care thromboprophylaxis via Fragmin. Participants will be followed for 3 years after surgery.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- Valeo Pharma Inc
- Responsible party
- Sponsor
- Investigators
- Anton Skaro, MD PhD, Principal investigator, Western Univeristy/LHSC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06153394
- Sponsor's protocol ID
- 123658
- Acronym
- PRIORITY
- Status last verified
- Apr 2024
- First submitted
- 22 Nov 2023
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not planning to share IPD with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prolonged Hypercoagulability Following Major Liver Resection for Malignancy
- ClinicalTrials.gov ID
- NCT06153394
- Acronym / sponsor ID
- PRIORITY / 123658
- Conditions
- Hepatic Disease, Surgery-Complications, Hypercoagulability, Thrombosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Collaborators
- Valeo Pharma Inc
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 1 Dec 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 clinical trial will investigate the ability of thromboelastrogrpahy (TEG®) to detect hypercoagulability after liver surgery and will examine the effect of extended thromboprophylaxis (medical treatment to prevent the development of blood clots inside blood vessels) in patients undergoing liver surgery for cancer treatment.
The liver plays a key role in regulating the process of blood clotting. As a result, blood clots are a major cause of complications and death following liver surgery. This is especially true in cancer patients who are at a higher risk of developing blood clots. Current methods for preventing clotting complications after liver surgery include conventional coagulation blood tests (CCTs) and anticoagulant drugs, such as low molecular weight heparins (LMWHs). Current LMWH treatment is prescribed for one month after surgery, but studies show that the risk of developing blood clots can last up to 3 months. Studies also show that CCTs may not be as effective in detecting clotting issues as more comprehensive testing systems, such as TEG. This study will randomize 50 participants to receive 90 days of thromboprophylaxis (using the LMWH Redesca) or the standard of care 30 days (using the LMWH Fragmin) after liver surgery. The medication will be given by injection, similar to a regular vaccine or an insulin injection. Participants will inject the medication every day, for 30 or 90 days, after surgery. Participants will also have their blood tested for clotting issues via TEG testing before surgery and on post-operative days 1,3,5,30 and 90. After surgery, participants will be monitored by their surgeon for clotting complications and 3 year disease-free survival.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This will be a phase III pilot trial where 50 participants will be randomized 1:1 to receive extended duration thromboprophylaxis via Redesca or standard of care thromboprophylaxis via Fragmin. Participants will be followed for 3 years after surgery.
| Arm | Type | Receives |
|---|---|---|
| Redesca | Experimental | Drug: Redesca (enoxaparin sodium for injection)Patients in the extended thromboprophylaxis group will receive Redesca (enoxaparin sodium for injection) (40mg) once a day, starting on the day of surgery, for 90 days postoperatively. |
| Fragmin | Active comparator | Drug: Fragmin (dalteparin)Patients in the standard of care group will receive Fragmin (daletparin) (5,000 I.U) once a day, starting on the day or surgery, for 30 days postoperatively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 years or older at the time of enrollment.
- Requiring major liver resection (>2 liver sections) for any oncologic indication.
- Requiring postoperative thromboprophylaxis will be included.
- Willing and able to perform subcutaneous injections according to the study protocol, or receive injections form a caregiver delegated by the participant.
Key exclusion criteria (6 listed)
- Anyone below 18 years of age.
- Patients on current anticoagulant and/or antiplatelet therapy
- Patients with a history of thrombotic events
- Patients with a coagulation disorder.
- Patients with recognized thrombophilia.
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 |
|---|---|---|
| Redesca (enoxaparin sodium for injection)Redesca is low molecular weight heparin and a biosimilar biologic drug (biosimilar) to Lovenox. Indications have been granted on the basis of similarity between Redesca and the reference biologic drug Lovenox. As such, Redesca (enoxaparin sodium) is indicated for thromboprophylaxis in patients undergoing high risk abdominal and colorectal surgeries. Doses are provided as self-administered subcutaneous injections using a pre-filled syringe with a protective shield. | Drug | Redesca |
| Fragmin (dalteparin)Fragmin is a low molecular weight heparin indicated for thromboprophylaxis in patients undergoing high risk abdominal and colorectal surgeries. Doses are provided as self-administered subcutaneous injections using a pre-filled syringe with a protective shield. Our institution uses this drug for standard of care thromboprophylaxis (30 days) in this patient population. | Drug | Fragmin |
Primary outcome
Number pf participants with hypercoagulability identified via TEG testing
Time frame: Preoperatively (with pre-admission blood work) through to 90 days postoperatively
All participants will have postoperative TEG testing performed for the detection of hypercoagulability.
2 secondary outcomes
Thrombotic Events
Time frame: Up to 6 months postoperatively
Disease Free Survival
Time frame: Up to 3 years postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Individual participant dataSharing planned: No. Not planning to share IPD with other researchers
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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.
Anton Skaro, MD PhD principal investigator
Western Univeristy/LHSC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Redesca (enoxaparin sodium for injection) and Fragmin (dalteparin) in people with Hepatic Disease and Surgery-Complications, run by Western University, Canada at 1 site in Canada.
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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 23 Apr 2024. 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 Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Crystal Engelage, PhD (519-685-8500 ext. 37517, Crystal.Engelage@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number pf participants with hypercoagulability identified via TEG testing (time frame: Preoperatively (with pre-admission blood work) through to 90 days postoperatively). 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 23 Apr 2024.