Clinical trial NCT04417231: CASTRO1 - Study on CRP Apheresis After Ischemic Stroke
Official title: Selective Depletion of C-reactive Protein by Therapeutic Apheresis (CRP-apheresis) in Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stroke, Ischemic
Lead sponsor: Pentracor GmbH
Sponsor class: INDUSTRY
First posted: 2020-06-04
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety of CRP apheresis
timeFrame: 24 hours after each apheresis
Secondary outcomes:
measure: Stroke Severity
timeFrame: before first apheresis and 6 ± 3 days after infarction and 12 ± 2 weeks after infarction
measure: Functional Outcome
timeFrame: before first apheresis and 6 ± 3 days after infarction and 12 ± 2 weeks after infarction
measure: Dependency
timeFrame: 6 ± 3 days after infarction and 12 ± 2 weeks after infarction
measure: Infarct size
timeFrame: 6 ± 3 days after infarction and 12 ± 2 weeks after infarction
measure: Concentration of inflammatory biomarkers (CRP, IL-6, SAA)
timeFrame: 0-7 days after infarction
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: Abteilung für Neurologie, Universität Ulm
state: Bayern
Study officials:
affiliation: Universitätsklinik Ulm, Abteilung für Neurologie
name: Johannes Dorst, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: