NCT03884153

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 21, 2019

Completed
1.7 years until next milestone

Study Start

First participant enrolled

December 3, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

March 25, 2022

Status Verified

March 1, 2022

Enrollment Period

1.7 years

First QC Date

March 19, 2019

Last Update Submit

March 24, 2022

Conditions

Stroke, Ischemic

Keywords

Ischemic StrokeCRP apheresis

Outcome Measures

Primary Outcomes (1)

  • Infarct growth

    Infarct growth measured via DWI-FLAIR volume change

    5 ± 1 days after infarction

Secondary Outcomes (7)

  • Infarct growth

    90 ± 14 days after infarction

  • Stroke Severity

    5 ± 1 days after infarction

  • Functional Outcome

    90 ± 14 days after infarction

  • Dependency

    90 ± 14 days after infarction

  • Cognitive Impairment

    90 ± 14 days after infarction

  • +2 more secondary outcomes

Study Arms (1)

CRP apheresis

EXPERIMENTAL

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

Device: CRP apheresis

Interventions

CRP apheresisDEVICE

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

CRP apheresis

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zentrum für Schlaganfallforschung (CSB) / Klinik für Neurologie mit Experimenteller Neurologie der Charité

Berlin, 12200, Germany

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Andreas Meisel, Prof. Dr. med.

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Benjamin Hotter, Dr. med.

CONTACT

+49 30 450 639729benjamin.hotter@charite.de

Andreas Meisel, Prof. Dr. med.

CONTACT

+49 30 450 560026andreas.meisel@charite.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Comparisons will be drawn from historic controls from previous observational stroke studies
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

March 19, 2019

First Posted

March 21, 2019

Study Start

December 3, 2020

Primary Completion

August 30, 2022

Study Completion

December 31, 2022

Last Updated

March 25, 2022

Record last verified: 2022-03

Locations

DE(1)