CASTRO-B

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-03

Study Completion Date

2022-12-31

Brief Summary

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This study explores the use of CRP level reduction in patients after suffering from acute ischemic stroke. Using selective CRP-apheresis, the investigators aim to reduce the secondary inflammatory tissue damage in the course of infarction maturation using infarction growth in MRI as the primary outcome as a surrogate.

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Detailed Description

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C-reactive protein (CRP) is an acute-phase protein binding to phosphocholine, thereby marking damaged tissue. This in turn activates the complement system and the cellular immune system engaging the unspecific immune system in an inflammatory tissue-degrading reaction. Such a pattern is observed in ischemic stroke, and elevated CRP levels can be measured in stroke survivors' sera. Several observational studies reproduced higher CRP levels with negative outcome in stroke. In another vascular model disease, myocardial infarction, selective CRP apheresis reduced infarct size in humans. The investigators therefore designed this pilot study to explore the effects of selective CRP reduction in ischemic stroke patients.

Conditions

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Stroke, Ischemic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Comparisons will be drawn from historic controls from previous observational stroke studies

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CRP apheresis

CRP apheresis by means of selective apheresis using the "PentraSorb"-CRP adsorber

Group Type EXPERIMENTAL

CRP apheresis

Intervention Type DEVICE

selective CRP apheresis by use of the "PentraSorb"-CRP

Interventions

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CRP apheresis

selective CRP apheresis by use of the "PentraSorb"-CRP

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age 18 - 85 years
* Informed consent signed by patient
* Patients with acute ischemic stroke in the Arteria cerebri media (MCA) territory within 36 hours of event
* Acute MRI with evidence of infarction
* NIHSS ≥ 4
* CRP \> 5 mg/l

Exclusion Criteria

* Withdrawal of consent
* Systolic blood pressure \<100 mmHg before the apheresis
* Blood pressure relevant extra- and intracranial stenoses (NASCET 70)
* Apheresis contraindication
* Participation in other interventional studies

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No