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Trial record 2 of 8 for:    CRP apheresis

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

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ClinicalTrials.gov Identifier: NCT04417231
Recruitment Status : Recruiting
First Posted : June 4, 2020
Last Update Posted : March 24, 2022
Sponsor:
Information provided by (Responsible Party):
Pentracor GmbH

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.


Condition or disease Intervention/treatment Phase
Stroke, Ischemic Device: CRP apheresis Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Selective Depletion of C-reactive Protein by Therapeutic Apheresis (CRP-apheresis) in Ischemic Stroke
Actual Study Start Date : January 28, 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ischemic Stroke

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.



Primary Outcome Measures :
  1. Safety of CRP apheresis [ Time Frame: 24 hours after each apheresis ]
    Incidence of expected and unexpected adverse effects


Secondary Outcome Measures :
  1. Stroke Severity [ Time Frame: before first apheresis and 6 ± 3 days after infarction and 12 ± 2 weeks after infarction ]
    National Institute of Health Stroke Scale (NIHSS) score - ranging from 0-42 - higher values represent a worse outcome

  2. Functional Outcome [ Time Frame: before first apheresis and 6 ± 3 days after infarction and 12 ± 2 weeks after infarction ]
    Modified ranking scale (mRS) score - ranging from 0-6 with higher scores signifying worse outcome

  3. Dependency [ Time Frame: 6 ± 3 days after infarction and 12 ± 2 weeks after infarction ]
    Barthel Index (BI) - ranging from 0-100 with higher scores signifying better outcome

  4. Infarct size [ Time Frame: 6 ± 3 days after infarction and 12 ± 2 weeks after infarction ]
    Infarct growth measured via diffusion-weighted imaging (DWI)-FLAIR volume change

  5. Concentration of inflammatory biomarkers (CRP, IL-6, SAA) [ Time Frame: 0-7 days after infarction ]
    CRP, Interleukin-6, and serum amyloid A are determined twice daily until discharge of the patient (for a maximum of 7 days).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04417231


Contacts
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Contact: Burghard Thiesen, Dr. 004915255318960 thiesen@pentracor.de

Locations
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Germany
Abteilung für Neurologie, Universität Ulm Recruiting
Ulm, Bayern, Germany
Contact: Johannes Dorst, MD         
Sponsors and Collaborators
Pentracor GmbH
Investigators
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Principal Investigator: Johannes Dorst, PD Dr. med. Universitätsklinik Ulm, Abteilung für Neurologie
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Responsible Party: Pentracor GmbH
ClinicalTrials.gov Identifier: NCT04417231    
Other Study ID Numbers: P-05 CASTRO1
First Posted: June 4, 2020    Key Record Dates
Last Update Posted: March 24, 2022
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Ischemic Stroke
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes