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Predicting Delayed cerebral ischemia using Micro- and Macrovascular parameters in Subarachnoid hemorrhage patients (PDMMS-study)

Predicting Delayed cerebral ischemia using Micro- and Macrovascular parameters in Subarachnoid hemorrhage patients (PDMMS-study) - MICRO- AND MACROVASCULAR PARAMETERS IN DELAYED CEREBRAL ISCHEMIA

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON54212
Enrollment
30
Registered
2021-11-22
Start date
2023-01-17
Completion date
Unknown
Last updated
2026-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delayed ischemic neurologic deficit (DIND) Secondary cerebral ischemia

Interventions

None listed

Sponsors

Medisch Universitair Ziekenhuis Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Age >= 18 years - Diagnosis of an aSAH according to the treating neurologist/neurosurgeon based on CTA/DSA. - Inclusion within 72h following ictus (to best capture glycocalyx integrity before DCI occurs)

Exclusion criteria

Exclusion criteria: -

Design outcomes

Primary

MeasureTime frame
- Feasibility of: 1. Sublingual and conjunctival glycocalyx measurements using SDF imaging, measured using the following parameters: o Success rate of measurements (number successful measurements/ number of required measurements, %) o Complications of measurements o Communication speed (between treating physician and investigator(s), measured as time from inclusion and from first signs of DCI to measurement) o Patient-specific obstacles (e.g. frontal syndrome, intubation, complications/adverse events) will be carefully reported o Software (technical issues) and human resources related obstacles (unavailability of investigator during DCI) measured as frequency of events or unavailability. o Global perceived experience of the patient with the SDF measurements, if the patients if fully aware/conscious (using a 5-point likert scale: I could tolerate the measurement well: completely disagree, disagree, neutral, agree, completely agree) 2. Determining patterns of Doppler signal morphology in aSAH and DCI patients o Doppler signal waveforms (normalized with respect to time (ms) and velocity (cm/s)

Secondary

MeasureTime frame
- Observed glycocalyx variability using: o SDF imaging measuring glycocalyx thickness derived from red blood cell column width (RBCC, in µm) and total perfused diameter (Dperf, in µm), expressed in Perfused Boundary Region (PBR, in µm) o Plasma markers of glycocalyx breakdown (ng/L) - Neuroinflammation o. Levels of plasma, tear fluid and CSF inflammatory cytokines - Macrovascular parameters o Using blood flow velocity expressed in cm/s. o Doppler signal waveform characteristics (normalized with respect to time (s) and velocity (cm/s)). - Microvascular parameters obtained from SDF imaging including vessel density (number of microvessels per mm2), vessel volume (mm3), vessel flow (cm/s), and capillary recruitment rate in aSAH patients (%) - Results of microvascular (from SDF imaging and plasma markers) and macrovascular parameters (TCD measurements) will be related to o mNHISS, WFNS, GCS o Surgical treatment (coiling, clipping, no treatment) o Aneurysm type, location, and size (from CTA/DSA) o SAH classification: WFNS (clinical) and Fisher classification (radiological) o Hbac1 on admission and glucose with each measurement o Functional outcome at six weeks and six months after ictus using the mRs score o Quality of life at six weeks and six months after ictus using the EQ-5D-5L questionnaire o Mortality at six weeks and six months after ictus Other study parameters: General demographic data will be reported: age, sex, weight and length (BMI), smoking, blood pressure, medication, and complications during admission (occurrence of infections like meningitis, pneumonia, hydrocephalus, endocrinological disorders). This data is routinely obtained from the electronic patient file and will not require additional measurements/actions. These parameters are possible confounders influencing glycocalyx measurements and will be included in logistic regressions.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Apr 23, 2026