An observational study in Intracerebral Hemorrhage and Hemorrhagic Stroke, sponsored by University Medical Centre Maribor. Not yet recruiting at 3 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by University Medical Centre Maribor · Observational
Spontaneous intracerebral haemorrhage (ICH) is a severe form of stroke with high mortality and frequent long-term disability. Current tools to predict how an individual patient will recover are limited.
CrossReg-4-Health is a prospective, multicentre observational cohort study that will enrol 300 consecutive adults with acute spontaneous ICH at three hospitals in Slovenia and Austria. During hospitalisation, the study will collect clinical data, standardised neurological and pain assessments, routine laboratory results, CT, CT angiography and MRI findings, and two research blood samples for biomarkers of brain injury, inflammation, coagulation and pain. Participants will be followed up at 6 and 12 months for survival, functional outcome, neurological status, pain, health-related quality of life, rehabilitation use and readmissions.
The main aim is to develop a multimodal prognostic model for functional outcome (modified Rankin Scale) 12 months after ICH.
Background: Outcome prediction after spontaneous intracerebral haemorrhage (ICH) relies mainly on clinical severity and neuroimaging markers and only partially captures multidimensional recovery. Blood-based biomarkers, pain burden, rehabilitation exposure, care trajectories and patient-reported outcomes are rarely integrated in prospective real-world cohorts.
Design: Prospective, multicentre, longitudinal observational cohort study conducted within the Interreg Slovenia-Austria project CrossReg-4-Health (grant SIAT00307). Approximately 100 consecutive patients will be enrolled at each of three centres (University Medical Centre Maribor; LKH-Universitätsklinikum Graz; Klinikum Klagenfurt am Wörthersee). Treatment follows routine clinical practice and is not influenced by study participation.
Assessments:
Biomarkers: S100B, GFAP, NfL, CRP, IL-6, TNF-alpha, IL-10, D-dimer and exploratory substance P, analysed centrally in batches. Remaining aliquots are stored in the institutional biobank only with separate optional consent.
Neuroimaging: haematoma volume and location, intraventricular haemorrhage, haematoma expansion, perihaematomal oedema, CTA spot sign, CT and MRI markers of cerebral small vessel disease (white matter hyperintensities, cerebral microbleeds, cortical superficial siderosis, lacunes, enlarged perivascular spaces) and MRI-based aetiology. CT-based radiomics and premorbid frailty indicators are exploratory.
Statistical analysis: The primary model is multivariable logistic regression for unfavourable outcome (mRS 4-6 vs 0-3) at 12 months with approximately 15 prespecified candidate predictor parameters (sample size checked using the Riley framework: outcome proportion 0.55, anticipated Cox-Snell R2 0.25, target shrinkage 0.90). Penalised regression may be used. Performance will be assessed by discrimination, calibration and overall performance, with internal validation by bootstrapping or cross-validation. The full ordinal mRS will be analysed with proportional odds regression as a secondary analysis. Mortality will be analysed with Kaplan-Meier methods and Cox regression. Missing data will be handled by multiple imputation, with complete-case sensitivity analysis.
Embedded substudy: A subset of up to 100 participants with upper-limb motor impairment will take part in an exploratory rehabilitation substudy of haptic-assisted virtual reality training, registered separately on ClinicalTrials.gov.
476 studies on the registry are indexed under Cerebral Hemorrhage; 178 are open to participants now.
This study's planned enrollment of 300 is close to the median of 287 across 181 observational studies indexed under Cerebral Hemorrhage.
Browse Cerebral Hemorrhage studies →University Medical Centre Maribor is the lead sponsor of 36 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Consecutive adults with acute spontaneous (non-traumatic) intracerebral haemorrhage admitted to stroke units, neurology wards, neurosurgical units or intensive care units of three hospital centres in Slovenia and Austria.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Consecutive adults with acute spontaneous intracerebral haemorrhage admitted to one of three participating centres, managed according to routine clinical practice.
Unfavourable functional outcome at 12 months (modified Rankin Scale 4-6)
Proportion of participants with mRS 4-6 (unfavourable) versus 0-3. The mRS ranges from 0 (no symptoms) to 6 (death); higher scores indicate worse outcome. Used as the outcome of the multivariable prognostic model.
Time frame: 12 months after ICH onset
Functional outcome on the full ordinal modified Rankin Scale at 12 months
Distribution of mRS scores (0 = no symptoms to 6 = death; higher scores indicate worse outcome), analysed with proportional odds regression.
Time frame: 12 months after ICH onset
Functional outcome at 6 months (modified Rankin Scale)
mRS score (0 = no symptoms to 6 = death; higher scores indicate worse outcome).
Time frame: 6 months after ICH onset
All-cause mortality
Proportion of participants who died from any cause.
Time frame: 30 days, 6 months and 12 months after ICH onset
Change in neurological deficit (NIHSS) during hospitalisation
National Institutes of Health Stroke Scale score (0-42; higher scores indicate more severe deficit).
Time frame: Admission, approximately 48 hours, and hospital discharge (up to approximately 4 weeks)
Neurological deficit at follow-up (NIHSS)
National Institutes of Health Stroke Scale score (0-42; higher scores indicate more severe deficit).
Time frame: 6 and 12 months after ICH onset
Pain burden during hospitalisation
Pain assessed hierarchically according to communication ability: Numeric Rating Scale 0-10 (higher = more pain) in communicative patients; Behavioural Pain Scale, revised Nociception Coma Scale, PAIC15 or Doloplus-2 in non-communicative patients.
Time frame: From admission to hospital discharge (up to approximately 4 weeks)
Pain intensity at follow-up (Numeric Rating Scale)
Numeric Rating Scale 0-10 (0 = no pain, 10 = worst imaginable pain).
Time frame: 6 and 12 months after ICH onset
Health-related quality of life (PROMIS-29)
PROMIS-29 domain T-scores (physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles, pain interference) and pain intensity item. Higher scores indicate more of the domain measured.
Time frame: 6 and 12 months after ICH onset
Self-rated health (EQ-5D VAS)
EuroQol visual analogue scale, 0 (worst imaginable health) to 100 (best imaginable health).
Time frame: 6 and 12 months after ICH onset
Intensive care unit length of stay
Days in the intensive care unit.
Time frame: From admission to hospital discharge (up to approximately 4 weeks)
ICU-to-ward transition time
Time from admission to transfer from the intensive care unit to a ward, in days.
Time frame: From admission to hospital discharge (up to approximately 4 weeks)
Total hospital length of stay
Days from admission to discharge.
Time frame: From admission to hospital discharge (up to approximately 4 weeks)
Discharge destination
Categories such as home, inpatient rehabilitation, long-term care facility, other hospital, or death.
Time frame: At hospital discharge (up to approximately 4 weeks)
Rehabilitation exposure
Type, setting and amount of rehabilitation received.
Time frame: From admission to 12 months after ICH onset
Hospital readmissions
Number of participants readmitted and number of readmissions.
Time frame: Up to 12 months after ICH onset
Plan to share: No — No, due to legal restrictions.
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Oct 2028, 23 months later.
Of 83 non-industry observational studies under Cerebral Hemorrhage, half reached primary completion within 62 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 127. This study's planned 23 months is below that.
Counting every sponsor, half of 85 studies reached it within 62 months; a quarter within 27 and three quarters within 127.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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University Medical Centre Maribor