Critical Limb IschemiaNCT03809494
HemaTrate™ in the Treatment of Critical Limb Ischemia
A study testing HemaTrate™ Blood Filtration system and Saline in people with Critical Limb Ischemia and Ischemia, run by Cook Research Incorporated at 3 sites in United Kingdom.
Trial summary
The primary objective of this study is to evaluate the performance of the HemaTrate™ Blood Filtration system in the treatment of critical limb ischemia. The primary endpoint measure is comparing the percentage of patients between the treatment arm and control arm who have freedom from major amputation, arterial… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Critical Limb Ischemia, Ischemia
- What is being tested?
- HemaTrate™ Blood Filtration system and Saline
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 23 Jul 2019to 27 Nov 2020
- Phase
- Interventional
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Critical Limb Ischemia in the study leg with ischemic rest pain and/or ulcer/minor tissue loss (Rutherford 4 or 5)
- Previously failed an endovascular or surgical treatment of the study lower leg and is not being considered for additional intervention within the next 3 months OR is unsuitable for revascularization
Who cannot join
- Simultaneously participating in another investigational study (e.g., drug or device)
- Pregnant or breastfeeding, or planning to become pregnant within the next 12 months
- Major surgery (open cardiac, vascular, or abdominal procedure) within the past 90 days
- Endovascular intervention within the past 30 days
- Current dialysis, or expected to need dialysis within the next 12 months
- Previous above the ankle amputation in the study leg
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
The Leeds Teaching Hospital NHS Trust
Leeds, West Yorkshire, LS9 7TF
St Thomas' Hospital
London, SE1 7EH
Manchester Royal Infirmary, Manchester Vascular Centre
Manchester, Great Britian, M13 9WL
About this study
Official title: Clinical Study of the Use of an Autologous Blood Filtration Device in the Treatment of Critical Limb Ischemia
The primary objective of this study is to evaluate the performance of the HemaTrate™ Blood Filtration system in the treatment of critical limb ischemia. The primary endpoint measure is comparing the percentage of patients between the treatment arm and control arm who have freedom from major amputation, arterial intervention below the knee, and death through 12 months.
- Conditions
- Critical Limb Ischemia, Ischemia
- Being tested
- HemaTrate™ Blood Filtration system, Saline
- Keywords
- lower extremity, Peripheral Arterial Disease, Ischemia, Peripheral Blood Stem Cell Transplantation, Leukocytes, Mononuclear, Transplantation, Autologous
- Medical subject headings
- Chronic Limb-Threatening Ischemia, Ischemia, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemaTrate™ Blood Filtration systemDevice
Anticoagulated whole blood is loaded into the filtration system. During gravity filtration, the majority of platelets, plasma, and red blood cells pass through the filter into a filtrate bag. The TNCs are captured in the filter material and recovered via a back-flush with 0.9 % saline into a syringe.
SalineOther
Normal (0.9%) saline
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Patients assigned to the treatment arm will be injected with autologous concentrated total nucleated cells (TNCs) three times at six week intervals. Receives: Device: HemaTrate™ Blood Filtration system |
| Saline (Control Arm) | Placebo comparator | Patients assigned to the control arm will be injected with saline three times at six week intervals. Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from vascular or endovascular arterial intervention below the knee of the study leg
Percent of patients that have vascular or endovascular arterial intervention reported below the knee of the study leg
Measured: 12 months
Freedom from major amputation of the study leg
Percent of patients that have any amputation above the ankle of the study leg
Measured: 12 months
Death
Percent of patients that exit due to death
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2019
- Study start23 Jul 2019
- Primary completion27 Nov 2020
- Study completion27 Nov 2020
Why it stopped: The study has stopped early due to enrollment challenges related largely to the current pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical Limb IschemiaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook Research Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bijan Modarai, PhD, FRCS, Study chair, St Thomas' HospitalVáclav Procházka, MD, PhD, MSc, Study chair, University Hospital OstravaGiulio Pompilio, MD, PhD, Study chair, Centro Cardiologico Monzino IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03809494
- Sponsor's protocol ID
- 15-03
- Status last verified
- Nov 2020
- First submitted
- 16 Jan 2019
- Last updated
- 2 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Cook Research Incorporated (CRI) is fully committed to supporting the principles of responsible data sharing, including providing qualified scientific researchers access to deidentified, patient-level data from CRI clinical studies to conduct legitimate scientific research. Data underlying the results reported in this clinical study will be made available for request after publication of the results from this study and ending 5 years after initial publication. Interested researchers may review the "Cook Research Incorporated Policy on Access to Clinical Study Data" at https://www.cookresearchinc.com/extranet/data-access.html and submit a complete research proposal to request data access. Additional study documents (such as the study protocol) will be shared as needed if the data access request is granted. A data sharing agreement will be executed for access to deidentified patient-level data.
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of the Use of an Autologous Blood Filtration Device in the Treatment of Critical Limb Ischemia
- ClinicalTrials.gov ID
- NCT03809494
- Acronym / sponsor ID
- 15-03
- Conditions
- Critical Limb Ischemia, Ischemia
- Keywords
- lower extremity, Peripheral Arterial Disease, Ischemia, Peripheral Blood Stem Cell Transplantation, Leukocytes, Mononuclear, Transplantation, Autologous
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study has stopped early due to enrollment challenges related largely to the current pandemic
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Cook Research IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 23 Jul 2019 (actual)
- Primary completion
- 27 Nov 2020 (actual)
- Study completion
- 27 Nov 2020 (actual)
- First posted
- 18 Jan 2019 (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.
The primary objective of this study is to evaluate the performance of the HemaTrate™ Blood Filtration system in the treatment of critical limb ischemia. The primary endpoint measure is comparing the percentage of patients between the treatment arm and control arm who have freedom from major amputation, arterial intervention below the knee, and death through 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Device: HemaTrate™ Blood Filtration systemPatients assigned to the treatment arm will be injected with autologous concentrated total nucleated cells (TNCs) three times at six week intervals. |
| Saline (Control Arm) | Placebo comparator | Other: SalinePatients assigned to the control arm will be injected with saline three times at six week intervals. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Critical Limb Ischemia in the study leg with ischemic rest pain and/or ulcer/minor tissue loss (Rutherford 4 or 5)
- Previously failed an endovascular or surgical treatment of the study lower leg and is not being considered for additional intervention within the next 3 months OR is unsuitable for revascularization
Key exclusion criteria (6 listed)
- Simultaneously participating in another investigational study (e.g., drug or device)
- Pregnant or breastfeeding, or planning to become pregnant within the next 12 months
- Major surgery (open cardiac, vascular, or abdominal procedure) within the past 90 days
- Endovascular intervention within the past 30 days
- Current dialysis, or expected to need dialysis within the next 12 months
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 |
|---|---|---|
| HemaTrate™ Blood Filtration systemAnticoagulated whole blood is loaded into the filtration system. During gravity filtration, the majority of platelets, plasma, and red blood cells pass through the filter into a filtrate bag. The TNCs are captured in the filter material and recovered via a back-flush with 0.9 % saline into a syringe. | Device | Treatment Arm |
| SalineNormal (0.9%) saline | Other | Saline (Control Arm) |
Primary outcome
Freedom from vascular or endovascular arterial intervention below the knee of the study leg
Time frame: 12 months
Percent of patients that have vascular or endovascular arterial intervention reported below the knee of the study leg
Freedom from major amputation of the study leg
Time frame: 12 months
Percent of patients that have any amputation above the ankle of the study leg
Death
Time frame: 12 months
Percent of patients that exit due to death
Results and safety
The study was stopped early (reason given: The study has stopped early due to enrollment challenges related largely to the current pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2020.
- Individual participant dataSharing planned: Undecided. Cook Research Incorporated (CRI) is fully committed to supporting the principles of responsible data sharing, including providing qualified scientific researchers access to deidentified, patient-level data from CRI clinical studies to conduct legitimate scientific research. Data underlying the results reported in this clinical study will be made available for request after publication of the results from this study and ending 5 years after initial publication. Interested researchers may review the "Cook Research Incorporated Policy on Access to Clinical Study Data" at https://www.cookresearchinc.com/extranet/data-access.html and submit a complete research proposal to request data access. Additional study documents (such as the study protocol) will be shared as needed if the data access request is granted. A data sharing agreement will be executed for access to deidentified patient-level data.
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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.
Bijan Modarai, PhD, FRCS study chair
St Thomas' Hospital
Václav Procházka, MD, PhD, MSc study chair
University Hospital Ostrava
Giulio Pompilio, MD, PhD study chair
Centro Cardiologico Monzino IRCCS
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HemaTrate™ Blood Filtration system and Saline in people with Critical Limb Ischemia and Ischemia, run by Cook Research Incorporated at 3 sites in United Kingdom.
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 2 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: stopped early, as of the sponsor's last update on 2 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study has stopped early due to enrollment challenges related largely to the current pandemic). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from vascular or endovascular arterial intervention below the knee of the study leg (time frame: 12 months). The study lists 3 primary outcomes in all. 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 2 Dec 2020.