CASTRO1 - Study on CRP Apheresis After Ischemic Stroke (CASTRO1)

Selective Depletion of C-reactive Protein by Therapeutic Apheresis (CRP-apheresis) in Ischemic Stroke

CASTRO1 is a study to investigate the reduction of C-reactive protein (CRP) by therapeutic apheresis (CRP-apheresis) in patients after primary treatment of ischemic stroke.

The term therapeutic apheresis commonly refers to medical procedures, where pathogenic constituents are being removed from the circulating blood. Elimination is performed by adsorbers outside the body in an extracorporeal circulation. For removal of the pathogenic substances the plasma is separated from the blood (circulation) to pass the adsorber. The purified plasma is merged with the solid blood components thereafter and returned to the patient.

The adsorber "PentraSorb® CRP" used for CRP apheresis is CE-certified. It is designated to the selective depletion of C-reactive protein from human blood.

Study Overview

• Status: Terminated
• Conditions: Stroke, Ischemic
• Intervention / Treatment: Device: CRP apheresis

Detailed Description

The purpose of the study is to evaluate the safety and efficacy of CRP apheresis in patients following ischemic stroke. CRP apheresis is to be conducted with the aim of reducing cerebral damage following the guideline-appropriate primary therapy of ischemic stroke.

A possible protective effect of CRP apheresis will be assessed by clinical scores, laboratory determination of immunologic parameters and determination of the size of the infarct area by magnetic resonance imaging (MRI).

The study will be randomized, controlled and monocentric.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Burghard Thiesen, Dr.; Phone Number: 004915255318960; Email: thiesen@pentracor.de

Study Locations

• Germany
  • Bayern
    • Ulm, Bayern, Germany
      • Abteilung für Neurologie, Universität Ulm

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Ischaemic stroke with determination of infarct size by imaging (MRI)
• NIHSS 1-24
• CRP increase ≥ 5 mg/l within presumed 72 hours after stroke and/or CRP value > 10 mg/l
• written informed consent of the patient or his legal representative

Exclusion Criteria:

• age < 18 years
• Severe dysphagia (danger of aspiration pneumonia)
• Clinical or laboratory evidence of a severe systemic infection
• Participation in other interventional studies
• Contraindications against apheresis therapy
• Modified Rankin Scale (mRS) before index event ≥ 3
• Intracranial hemorrhage
• Epileptic seizure in the context of the acute event
• Pregnancy, lactation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Apheresis group; 10 patients receive a maximum of 3 apheresis treatments at intervals of 24 ± 12 hours each (from the beginning of the preceding treatment). The first treatment starts within 72 hours after infarction or, in case of an unclear time window, within presumed 72 hours after the patient was last seen free of symptoms. No further treatments are carried out if the CRP concentration before the start of a treatment is <10 mg/l or if the patient has been discharged from hospital. For each treatment, 1.5 - 2.5 times the plasma volume is processed. The duration of each treatment is approximately 4-6 hours.	Device: CRP apheresis; Selective CRP apheresis by use of the "PentraSorb"-CRP
No Intervention: Control group; 10 patients of the control group receive the same examinations as arm 1 (verum group) but no apheresis treatments after ischemic stroke.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of CRP apheresis	Incidence of expected and unexpected adverse effects	24 hours after each apheresis

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stroke Severity	National Institute of Health Stroke Scale (NIHSS) score - ranging from 0-42 - higher values represent a worse outcome	before first apheresis and 6 ± 3 days after infarction and 12 ± 2 weeks after infarction
Functional Outcome	Modified ranking scale (mRS) score - ranging from 0-6 with higher scores signifying worse outcome	before first apheresis and 6 ± 3 days after infarction and 12 ± 2 weeks after infarction
Dependency	Barthel Index (BI) - ranging from 0-100 with higher scores signifying better outcome	6 ± 3 days after infarction and 12 ± 2 weeks after infarction
Infarct size	Infarct growth measured via diffusion-weighted imaging (DWI)-FLAIR volume change	6 ± 3 days after infarction and 12 ± 2 weeks after infarction
Concentration of inflammatory biomarkers (CRP, IL-6, SAA)	CRP, Interleukin-6, and serum amyloid A are determined twice daily until discharge of the patient (for a maximum of 7 days).	0-7 days after infarction

Collaborators and Investigators

• Sponsor: Pentracor GmbH
• Investigators: Principal Investigator: Johannes Dorst, PD Dr. med., Universitätsklinik Ulm, Abteilung für Neurologie

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2021
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: May 29, 2020
• First Submitted That Met QC Criteria: June 3, 2020
• First Posted (Actual): June 4, 2020

Study Record Updates

• Last Update Posted (Actual): May 18, 2023
• Last Update Submitted That Met QC Criteria: May 17, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke; Ischemia
• Other Study ID Numbers: P-05 CASTRO1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No