NCT03809494

HemaTrate™ in the Treatment of Critical Limb Ischemia

Clinical Study of the Use of an Autologous Blood Filtration Device in the Treatment of Critical Limb Ischemia

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Cook Research Incorporated · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2019-07-23
• Primary completion: 2020-11-27
• Completion: 2020-11-27
• First posted: 2019-01-18
• Last updated: 2020-12-02

Locations

3 sites across 1 country: United Kingdom