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HemaTrate™ in the Treatment of Critical Limb Ischemia

NCT03809494 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2020-12-02

No results posted yet for this study

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.

Conditions

  • Critical Limb Ischemia
  • Ischemia

Interventions

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.

OTHER

Saline

Normal (0.9%) saline

Sponsors & Collaborators

  • Cook Research Incorporated

    lead INDUSTRY

Principal Investigators

  • Bijan Modarai, PhD, FRCS · St Thomas' Hospital

  • Václav Procházka, MD, PhD, MSc · University Hospital Ostrava

  • Giulio Pompilio, MD, PhD · Centro Cardiologico Monzino IRCCS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-23
Primary Completion
2020-11-27
Completion
2020-11-27

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03809494 on ClinicalTrials.gov