CASTRO1 - Study on CRP Apheresis After Ischemic Stroke

Pentracor

Status: Terminated

Conditions: Stroke, Ischemic

Treatments: Device: CRP apheresis

Study type: Interventional

Funder types: Industry

Identifiers

NCT04417231

P-05 CASTRO1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3 participants in 2 patient groups

Apheresis group

Experimental group

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.

Treatment:

Device: CRP apheresis

Control group

No Intervention group

Description:

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