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HemaTrate™ in the Treatment of Critical Limb Ischemia

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ClinicalTrials.gov Identifier: NCT03809494
Recruitment Status : Not yet recruiting
First Posted : January 18, 2019
Last Update Posted : February 5, 2019
Sponsor:
Information provided by (Responsible Party):
Cook Group Incorporated ( Cook Research Incorporated )

Brief 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 intervention below the knee, and death through 12 months.

Condition or disease Intervention/treatment Phase
Critical Limb Ischemia Ischemia Device: HemaTrate™ Blood Filtration system Other: Saline Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: Investigator for this study is the person that will be performing the TNC or saline injections throughout the study and will not be masked. The investigator will not be assigned to perform the scheduled follow-up contacts.
Primary Purpose: Treatment
Official Title: Clinical Study of the Use of an Autologous Blood Filtration Device in the Treatment of Critical Limb Ischemia
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : January 2026

Arm Intervention/treatment
Experimental: Treatment Arm
Patients assigned to the treatment arm will be injected with autologous concentrated total nucleated cells (TNCs) three times at six week intervals.
Device: HemaTrate™ Blood Filtration system
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.

Placebo Comparator: Saline (Control Arm)
Patients assigned to the control arm will be injected with saline three times at six week intervals.
Other: Saline
Normal (0.9%) saline




Primary Outcome Measures :
  1. 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

  2. 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

  3. Death [ Time Frame: 12 months ]
    Percent of patients that exit due to death



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Critical Limb Ischemia in the study leg with ischemic rest pain and/or ulcer/minor tissue loss (Rutherford 4 or 5)
  2. 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

Exclusion Criteria:

  1. Simultaneously participating in another investigational study (e.g., drug or device)
  2. Pregnant or breastfeeding, or planning to become pregnant within the next 12 months
  3. Major surgery (open cardiac, vascular, or abdominal procedure) within the past 90 days
  4. Endovascular intervention within the past 30 days
  5. Current dialysis, or expected to need dialysis within the next 12 months
  6. Previous above the ankle amputation in the study leg

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03809494


Contacts
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Contact: Heather Maxwell 765-463-7537 heather.maxwell@cookmedical.com
Contact: Emil Hofdahl +45 56868428 emil.hofdahl@cookmedical.com

Locations
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Czechia
University Hospital Ostrava Not yet recruiting
Ostrava, Czechia, 70852
Poland
Upper Silesian Medical Centre Not yet recruiting
Katowice, Poland, 40-635
United Kingdom
St Thomas' Hospital Not yet recruiting
London, United Kingdom, SE1 7EH
Manchester Royal Infirmary Not yet recruiting
Manchester, United Kingdom, M13 9WL
Newcastle Upon Tyne Hospital NHS Not yet recruiting
Newcastle, United Kingdom, NE7 7DN
Sponsors and Collaborators
Cook Research Incorporated
Investigators
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Study Chair: Bijan Modari, MD St Thomas' Hospital
Study Chair: Vaclav Prochazka University Hospital, Ostrava, Czech Repbulic

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Responsible Party: Cook Research Incorporated
ClinicalTrials.gov Identifier: NCT03809494     History of Changes
Other Study ID Numbers: 15-03
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: 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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Cook Group Incorporated ( Cook Research Incorporated ):
lower extremity
Peripheral Arterial Disease
Ischemia
Peripheral Blood Stem Cell Transplantation
Leukocytes, Mononuclear
Transplantation, Autologous

Additional relevant MeSH terms:
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Ischemia
Pathologic Processes