NCT07056907

Effects of Cerebrospinal Fluid Drainage on Cerebral Hemodynamics

Not yet recruiting NA Last updated 9 July 2025

What this trial tests

NA trial testing Lumbar drain placement in Acute Ischemic Stroke in 30 participants. Not yet recruiting.

Timeline

1 November 2025

Primary endpoint
30 October 2027

30 January 2028

Quick facts

Lead sponsor	University of Zurich
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	30
Start date	1 November 2025
Primary completion	30 October 2027
Estimated completion	30 January 2028
Sites	1 location across Switzerland

Drugs / interventions tested

• Lumbar drain placement

Conditions studied

• Acute Ischemic Stroke — all drugs for Acute Ischemic Stroke →

Sponsor

University of Zurich

Who can join

18 and older, any sex, with Acute Ischemic Stroke. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.