NCT07056907Toborzás még nem indult

Effects of Cerebrospinal Fluid Drainage on Cerebral Hemodynamics

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

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. júl. 9. · Több mint 12 hónapja nem frissült - kérdezd meg a helyszínt, nyitott-e még

Rövid összefoglaló (regiszter, angolul)

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.

Állapot (regiszter): Toborzás még nem indult
Vizsgálattípus: Beavatkozással járó
Résztvevők száma: 30 (tervezett)
Első benyújtás: 2025. jún. 18.
Kezdés: 2025. nov. 1.
Elsődleges befejezés: 2027. okt. 30.
Fő szponzor: University of Zurich
Betegségek: Stroke (szélütés)
NCT-szám: NCT07056907

Mit vállalsz

Vizsgálat típusa: Beavatkozással járó
Tervezett résztvevők: 30
2025. nov. 1. és az elsődleges befejezés (2027. okt. 30.) között
1 helyszín, 1 országban
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Korábbi kezelés

Contraindications for MRI, including but not limited to:
- o Pacemakers, metallic implants/prostheses, metallic tattoo dyes.
Extensive lumbar surgery history.

Más betegség

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.
Presence of intracranial hemorrhage class >1 (per Heidelberg classification).
Malignant infarction syndrome (supratentorial or infratentorial).
New-onset seizures after stroke onset.
Local or systemic infection:
Infection at the lumbar drain insertion site.
Systemic infection at the time of enrollment.
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.

Laborértékek

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

Egyéb

Inclusion in any other running scientific study
Severe glaucoma.
Unwillingness or inability to perform breathing maneuvers required for BOLD-CVR assessment.
Obstructive hydrocephalus, including:
- Aqueductal stenosis.
- Enlarged lateral and third ventricles with a normal fourth ventricle.
Unilateral or bilateral subdural hematomas.
Decreased level of consciousness at enrollment, not due to aphasia
Structural spinal abnormalities, including:
- Spina bifida.
- Scoliosis affecting lumbar puncture feasibility.
Pregnant (confirmed or verbally suspected) or lactating women.

Kiket keres a vizsgálat

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.

Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (1)

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Helyszín	Város	Ország	Helyszín állapota
University Hospital Zurich Ennek a helyszínnek vagy a koordinátora? Erősítsd meg az állapotát	Zurich	Svájc	Ismeretlen állapot

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