<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04417231</url>
  </required_header>
  <id_info>
    <org_study_id>P-05 CASTRO1</org_study_id>
    <nct_id>NCT04417231</nct_id>
  </id_info>
  <brief_title>CASTRO1 - Study on CRP Apheresis After Ischemic Stroke</brief_title>
  <acronym>CASTRO1</acronym>
  <official_title>Selective Depletion of C-reactive Protein by Therapeutic Apheresis (CRP-apheresis) in Ischemic Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pentracor GmbH</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pentracor GmbH</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      CASTRO1 is a study to investigate the reduction of C-reactive protein (CRP) by therapeutic&#xD;
      apheresis (CRP-apheresis) in patients after primary treatment of ischemic stroke.&#xD;
&#xD;
      The term therapeutic apheresis commonly refers to medical procedures, where pathogenic&#xD;
      constituents are being removed from the circulating blood. Elimination is performed by&#xD;
      adsorbers outside the body in an extracorporeal circulation. For removal of the pathogenic&#xD;
      substances the plasma is separated from the blood (circulation) to pass the adsorber. The&#xD;
      purified plasma is merged with the solid blood components thereafter and returned to the&#xD;
      patient.&#xD;
&#xD;
      The adsorber &quot;PentraSorb® CRP&quot; used for CRP apheresis is CE-certified. It is designated to&#xD;
      the selective depletion of C-reactive protein from human blood.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of the study is to evaluate the safety and efficacy of CRP apheresis in patients&#xD;
      following ischemic stroke. CRP apheresis is to be conducted with the aim of reducing cerebral&#xD;
      damage following the guideline-appropriate primary therapy of ischemic stroke.&#xD;
&#xD;
      A possible protective effect of CRP apheresis will be assessed by clinical scores, laboratory&#xD;
      determination of immunologic parameters and determination of the size of the infarct area by&#xD;
      magnetic resonance imaging (MRI).&#xD;
&#xD;
      The study will be randomized, controlled and monocentric.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    sufficient recruitment of study patients based on the existing (and repeatedly adjusted)&#xD;
    inclusion and exclusion criteria is not possible within a reasonable period of time&#xD;
  </why_stopped>
  <start_date type="Actual">January 28, 2021</start_date>
  <completion_date type="Actual">December 31, 2022</completion_date>
  <primary_completion_date type="Actual">December 31, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety of CRP apheresis</measure>
    <time_frame>24 hours after each apheresis</time_frame>
    <description>Incidence of expected and unexpected adverse effects</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Stroke Severity</measure>
    <time_frame>before first apheresis and 6 ± 3 days after infarction and 12 ± 2 weeks after infarction</time_frame>
    <description>National Institute of Health Stroke Scale (NIHSS) score - ranging from 0-42 - higher values represent a worse outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Outcome</measure>
    <time_frame>before first apheresis and 6 ± 3 days after infarction and 12 ± 2 weeks after infarction</time_frame>
    <description>Modified ranking scale (mRS) score - ranging from 0-6 with higher scores signifying worse outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dependency</measure>
    <time_frame>6 ± 3 days after infarction and 12 ± 2 weeks after infarction</time_frame>
    <description>Barthel Index (BI) - ranging from 0-100 with higher scores signifying better outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infarct size</measure>
    <time_frame>6 ± 3 days after infarction and 12 ± 2 weeks after infarction</time_frame>
    <description>Infarct growth measured via diffusion-weighted imaging (DWI)-FLAIR volume change</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration of inflammatory biomarkers (CRP, IL-6, SAA)</measure>
    <time_frame>0-7 days after infarction</time_frame>
    <description>CRP, Interleukin-6, and serum amyloid A are determined twice daily until discharge of the patient (for a maximum of 7 days).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Stroke, Ischemic</condition>
  <arm_group>
    <arm_group_label>Apheresis group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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 &lt;10 mg/l or if the patient has been discharged from hospital.&#xD;
For each treatment, 1.5 - 2.5 times the plasma volume is processed. The duration of each treatment is approximately 4-6 hours.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>10 patients of the control group receive the same examinations as arm 1 (verum group) but no apheresis treatments after ischemic stroke.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CRP apheresis</intervention_name>
    <description>Selective CRP apheresis by use of the &quot;PentraSorb&quot;-CRP</description>
    <arm_group_label>Apheresis group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ischaemic stroke with determination of infarct size by imaging (MRI)&#xD;
&#xD;
          -  NIHSS 1-24&#xD;
&#xD;
          -  CRP increase ≥ 5 mg/l within presumed 72 hours after stroke and/or CRP value &gt; 10 mg/l&#xD;
&#xD;
          -  written informed consent of the patient or his legal representative&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age &lt; 18 years&#xD;
&#xD;
          -  Severe dysphagia (danger of aspiration pneumonia)&#xD;
&#xD;
          -  Clinical or laboratory evidence of a severe systemic infection&#xD;
&#xD;
          -  Participation in other interventional studies&#xD;
&#xD;
          -  Contraindications against apheresis therapy&#xD;
&#xD;
          -  Modified Rankin Scale (mRS) before index event ≥ 3&#xD;
&#xD;
          -  Intracranial hemorrhage&#xD;
&#xD;
          -  Epileptic seizure in the context of the acute event&#xD;
&#xD;
          -  Pregnancy, lactation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Johannes Dorst, PD Dr. med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitätsklinik Ulm, Abteilung für Neurologie</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Abteilung für Neurologie, Universität Ulm</name>
      <address>
        <city>Ulm</city>
        <state>Bayern</state>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>May 17, 2023</last_update_submitted>
  <last_update_submitted_qc>May 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Ischemic Stroke</mesh_term>
    <mesh_term>Ischemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04417231
org study id: P-05 CASTRO1
nct id: NCT04417231
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety of CRP apheresis
time frame: 24 hours after each apheresis
description: Incidence of expected and unexpected adverse effects
measure: Stroke Severity
time frame: before first apheresis and 6 ± 3 days after infarction and 12 ± 2 weeks after infarction
description: National Institute of Health Stroke Scale (NIHSS) score - ranging from 0-42 - higher values represent a worse outcome
measure: Functional Outcome
time frame: before first apheresis and 6 ± 3 days after infarction and 12 ± 2 weeks after infarction
description: Modified ranking scale (mRS) score - ranging from 0-6 with higher scores signifying worse outcome
measure: Dependency
time frame: 6 ± 3 days after infarction and 12 ± 2 weeks after infarction
description: Barthel Index (BI) - ranging from 0-100 with higher scores signifying better outcome
measure: Infarct size
time frame: 6 ± 3 days after infarction and 12 ± 2 weeks after infarction
description: Infarct growth measured via diffusion-weighted imaging (DWI)-FLAIR volume change
measure: Concentration of inflammatory biomarkers (CRP, IL-6, SAA)
time frame: 0-7 days after infarction
description: CRP, Interleukin-6, and serum amyloid A are determined twice daily until discharge of the patient (for a maximum of 7 days).
arm group label: Apheresis group
arm group type: Experimental
description: 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.
arm group label: Control group
arm group type: No Intervention
description: 10 patients of the control group receive the same examinations as arm 1 (verum group) but no apheresis treatments after ischemic stroke.
intervention type: Device
intervention name: CRP apheresis
description: Selective CRP apheresis by use of the "PentraSorb"-CRP
arm group label: Apheresis group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Johannes Dorst, PD Dr. med.
role: Principal Investigator
affiliation: Universitätsklinik Ulm, Abteilung für Neurologie
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Stroke
mesh term: Ischemic Stroke
mesh term: Ischemia
sharing ipd: No