CASTRO1 - Study on CRP Apheresis After Ischemic Stroke

NCT04417231 | Terminated

• 1 other identifier: P-05 CASTRO1
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Ischemic

Outcome Measures

Primary Outcomes (1)

• Safety of CRP apheresis

  Incidence of expected and unexpected adverse effects

  24 hours after each apheresis

Secondary Outcomes (5)

• Stroke Severity

  before first apheresis and 6 ± 3 days after infarction and 12 ± 2 weeks after infarction

• Functional Outcome

  before first apheresis and 6 ± 3 days after infarction and 12 ± 2 weeks after infarction

• Dependency

  6 ± 3 days after infarction and 12 ± 2 weeks after infarction

• Infarct size

  6 ± 3 days after infarction and 12 ± 2 weeks after infarction

• Concentration of inflammatory biomarkers (CRP, IL-6, SAA)

  0-7 days after infarction

Study Arms (2)

Apheresis group

EXPERIMENTAL

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

Control group

NO INTERVENTION

10 patients of the control group receive the same examinations as arm 1 (verum group) but no apheresis treatments after ischemic stroke.

Interventions

CRP apheresis DEVICE

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

Apheresis group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pentracor GmbH: lead

Study Sites (1)

Abteilung für Neurologie, Universität Ulm

Ulm, Bavaria, Germany

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Johannes Dorst, PD Dr. med.

  Universitätsklinik Ulm, Abteilung für Neurologie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2020
• First Posted: June 4, 2020
• Study Start: January 28, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: May 18, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)