Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

NOT YET RECRUITING

NCT07056907

Effects of Cerebrospinal Fluid Drainage on Cerebral Hemodynamics

Sponsor: University of Zurich

View on ClinicalTrials.gov

Summary

This pilot interventional study investigates whether continuous cerebrospinal fluid (CSF) drainage via lumbar drain can improve cerebrovascular reactivity (CVR) in patients with acute ischemic stroke and hemodynamic failure, as assessed by blood oxygenation level dependent (BOLD) MRI. Patients with acute ischemic stroke frequently exhibit impaired cerebral autoregulation and reduced vascular reserve. In such cases, a low BOLD-CVR response is associated with a high (\~40%) risk of recurrent ischemic stroke despite optimal medical therapy. Hemodynamic failure stage 2 (HF2), defined by severely reduced CVR (hemispheric BOLD-CVR ≤ 0.1041), indicates exhausted compensatory capacity and poor perfusion. Evidence from other neurological conditions suggests that CSF drainage via lumbar drain may transiently lower intracranial pressure, improve perfusion, and enhance autoregulatory function. This study aims to apply these findings to acute stroke patients with hemodynamic compromise. Eligible patients will undergo BOLD-CVR MRI to assess cerebrovascular reserve. Those meeting HF2 criteria and without contraindications will be offered inclusion. After informed consent (or proxy consent), a lumbar drain will be placed, and continuous CSF drainage performed over \~48 hours. A follow-up BOLD-CVR MRI will assess changes in CVR. In addition, 20 ml of CSF will be extracted to evaluate acute effects on CVR. A historical cohort will be used to control for spontaneous CVR variation over 48 hours. Primary Objective: To determine whether continuous CSF drainage improves BOLD-CVR in patients with HF2 following acute ischemic stroke. Secondary Objectives: To compare longitudinal BOLD-CVR changes to a historical cohort. To evaluate safety and feasibility of lumbar drainage in this setting. To assess short-term clinical outcomes (NIHSS, mRS) and recurrent events. To assess BOLD-CVR change after 20 ml CSF extraction. Study Design: Single-center, open-label, prospective pilot study. Participants serve as their own control, with pre- and post-intervention imaging to evaluate physiological effects. Safety and exploratory clinical data will also be collected. This proof-of-concept trial aims to generate preliminary evidence for a potential therapeutic strategy in high-risk stroke patients with poor autoregulation. Positive findings could inform future randomized controlled trials.

Official title: Evaluating the Neuroprotective Effects of Continuous Lumbar Drainage on the Cerebral Perfusion in Patients With an Acute Ischemic Stroke and Hemodynamic Failure Type 2: a Pilot Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-11-01

Completion Date

2028-01-30

Last Updated

2025-07-09

Healthy Volunteers

Conditions

Acute Ischemic Stroke

Interventions

PROCEDURE

Lumbar drain placement

This intervention involves temporary cerebrospinal fluid (CSF) drainage via lumbar drain in acute ischemic stroke patients with MRI-confirmed hemodynamic failure. The lumbar drain is inserted at the bedside or in a procedural suite under sterile conditions and connected to a pressure-regulated, closed drainage system. Drainage is continuous for 48-72 hours, with volume and pressure carefully monitored. This intervention is distinct in targeting stroke patients without hydrocephalus, using CSF drainage as a novel method to improve cerebral perfusion and vascular reserve. The effect is evaluated with serial BOLD-CVR MRI performed before and after the drainage period, making this one of the first interventional stroke studies to use functional MRI as a physiological endpoint.

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.

Locations (1)

University Hospital Zurich

Zurich, Canton of Zurich, Switzerland