CASTRO1 - Study on CRP Apheresis After Ischemic Stroke

Stroke, Ischemic Clinical Trial

— CASTRO1  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04417231
• Other study ID #: P-05 CASTRO1
• Status: Terminated
• Phase: N/A
• Start date: January 28, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2023
• Source: Pentracor GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ischemia
• Ischemic Stroke
• Stroke
• Stroke, Ischemic

Intervention

Device:
• CRP apheresis
Selective CRP apheresis by use of the "PentraSorb"-CRP

Locations

Country	Name	City	State
Germany	Abteilung für Neurologie, Universität Ulm	Ulm	Bayern

Sponsors (1)

Lead Sponsor	Collaborator
Pentracor GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of CRP apheresis	Incidence of expected and unexpected adverse effects	24 hours after each apheresis
Secondary	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
Secondary	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
Secondary	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
Secondary	Infarct size	Infarct growth measured via diffusion-weighted imaging (DWI)-FLAIR volume change	6 ± 3 days after infarction and 12 ± 2 weeks after infarction
Secondary	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