Effects of Cerebrospinal Fluid Drainage on Cerebral Hemodynamics

Launched by UNIVERSITY OF ZURICH · Jun 27, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring whether draining a small amount of fluid from around the spinal cord (called cerebrospinal fluid or CSF) can help improve blood flow regulation in the brain after an acute ischemic stroke—a type of stroke caused by a blocked blood vessel. Some stroke patients have trouble with their brain’s ability to manage blood flow, which can increase the risk of another stroke. This study will see if using a thin tube placed in the lower back to continuously drain CSF over about two days can improve this blood flow control, as measured by special MRI scans. The goal is to find out if this approach is safe and can help the brain recover better in patients who have poor blood flow regulation after a stroke.

Patients who had a recent ischemic stroke affecting certain major brain arteries and show signs of poor blood flow control on initial MRI scans may be eligible. Participants will have a lumbar drain placed to remove CSF continuously for around 48 hours, with MRI scans before and after to check for improvements. A small amount of CSF will also be removed at one point to see immediate effects. The study is carefully designed to monitor safety and gather early information to guide future research. People with certain health conditions or risks, such as infections, bleeding, or severe lung or heart problems, won’t be eligible. If you or a loved one fits these criteria and is interested, this study could offer a new way to support brain recovery after stroke.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male and female patients \> 18 years old
• • Acute ischemic stroke related to a new uni- or bilateral occlusion of the ICA, MCA (M1- and or M2 segment) or both
• • Persisting vascular pathology after the initial treatment.
• • Hemodynamic impairment on the BOLD-CVR done within 48 hours after stroke onset.
• • Capable of providing informed consent as documented by signature, or if unable, the next of kin (legally authorized representative) must be available for medical decision-making.
• Exclusion Criteria:
• • Inclusion in any other running scientific study
• * Contraindications for MRI, including but not limited to:
• • o Pacemakers, metallic implants/prostheses, metallic tattoo dyes.
• • Severe glaucoma.
• • Unwillingness or inability to perform breathing maneuvers required for BOLD-CVR assessment.
• * Major cardiopulmonary diseases, including:
• • Severe uncontrolled asthma bronchiale.
• • Severe chronic obstructive pulmonary disease (COPD, GOLD Stage \>2).
• • Diffuse interstitial lung disease.
• • Recent myocardial infarction (acute/subacute).
• • Severe heart failure (NYHA class \>2).
• * Symptomatic increased intracranial pressure (ICP) or related conditions:
• • Absent/compressed basal cisterns.
• • Compression or displacement of the fourth ventricle.
• • Cerebellar tonsillar herniation (\>5mm below the foramen magnum) on initial CT/MRI or on MRI at Day 1.
• * Obstructive hydrocephalus, including:
• • Aqueductal stenosis.
• • Enlarged lateral and third ventricles with a normal fourth ventricle.
• • Presence of intracranial hemorrhage class \>1 (per Heidelberg classification).
• • Unilateral or bilateral subdural hematomas.
• • Malignant infarction syndrome (supratentorial or infratentorial).
• • Decreased level of consciousness at enrollment, not due to aphasia
• • New-onset seizures after stroke onset.
• • Extensive lumbar surgery history.
• * Local or systemic infection:
• • Infection at the lumbar drain insertion site.
• • Systemic infection at the time of enrollment.
• * Severe coagulopathy, including:
• • Moderate/severe thrombocytopenia (\<100,000 platelets/µL).
• • Hemophilia or other coagulation disorders.
• • Use of anticoagulants (except for platelet aggregation inhibitors) that cannot be stopped.
• • Within 24 hours after intravenous thrombolysis
• * Structural spinal abnormalities, including:
• • Spina bifida.
• • Scoliosis affecting lumbar puncture feasibility.
• • Pregnant (confirmed or verbally suspected) or lactating women.
• * Inability to follow the procedures of the study, including but not limited to:
• • Severe cognitive impairment (e.g., dementia).
• • Psychiatric disorders affecting cooperation.
• • Severe language barriers preventing study compliance.
• • Failure to insert the lumbar drain.