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Prehospital and Acute Phase Characteristics of Severe Spontaneous ICH

Associations Between Prehospital Physiological Parameters and Functional Outcome in Severe Spontaneous Intracerebral Hemorrhage: a Retrospective Cohort Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07739030
Enrollment
678
Registered
2026-07-31
Start date
2016-11-01
Completion date
2026-04-01
Last updated
2026-07-31

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

Conditions

ICH - Intracerebral Hemorrhage, Intracerebral Haemorrhage, Intracerebral Haemorrhage, Intraventricular, Spontaneous Intracerebral Hemorrhage

Keywords

Spontaneous ICH, Primary ICH, IVH, stroke, neurointensive care, Withdrawal of life sustaining treatment, functional outcome, Neurocritical care, Prehospital

Brief summary

Spontaneous intracerebral hemorrhage (ICH) represents 10-15% of all strokes and is associated with high mortality and morbidity. Rapid identification and interventions, e.g. early implementation of care bundles, seem to be critical for improving outcome. Nonetheless, relatively little is known about the influence of acute physiological risk factors in the prehospital phase, although high prehospital blood pressure has been associated with worse outcome in mild to moderate ICH. Whether the same applies to severe ICH requiring neurointensive care is unclear and furthermore the prognostic impact of other physiological variables has received little attention. The aim of this study is to retrospectively investigate prehospital characteristics of severe ICH and whether physiological abnormalities are associated with functional outcome, mortality after six months, and early withdrawal of life sustaining treatment.

Detailed description

This study investigates the association between prehospital blood pressure, neurological deficits, glucose, hypoxia and outcome in patients admitted to the neurointensive care unit at Copenhagen University Hospital, Rigshospitalet, between 11-01-2016 and 10-01-2025. All data pertaining to the first 24 hours from admission to first hospital, baseline characteristics, comorbidities, decisions to withdraw care within 24 hours and functional outcome and mortality at six months were extracted from electronic medical journals, while prehospital data was extracted from the Danish National Prehospital Database and supplemented with scanned EMS records when available.

Interventions

None listed

Sponsors

Kirsten Moller
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Primary spontaneous ICH confirmed by CT imaging. * Admission to the neurointensive care unit at Rigshospitalet within the study period. * Available prehospital journal linked to the initial hospital admission.

Exclusion criteria

* Age below 18 * ICH secondary to trauma, vascular malformation, tumour, haemorrhagic transformation of ischaemic stroke, aneurysms, or central venous sinus thrombosis. * Initial admission without confirmed ICH. * Admissions from hospitals outside the Capital Region of Denmark or Region Zealand. * Pure intraventricular hemorrhage without parenchymal involvement as determined by a radiologist. * Intrahospital ICH. * Iatrogenic ICH

Design outcomes

Primary

MeasureTime frameDescription
Functional status at 6 monthsTime Frame: From ictus onset of symptoms or last seen well to six monthsModified Rankin Scale, mRS, (0-6 where lower scores mean a better outcome), with favourable outcomes defined as mRS of 0-3 and unfavourable 4-6
Mortality at 6 monthsFrom ictus to six monthsPercent
Early withdrawal of life sustaining treatmentFirst 24 hours from admission to primary hospitalPercent

Secondary

MeasureTime frameDescription
In hospital deathFrom hospital admission at day 1 until any death date coinciding with hospital discharge, assessed up to 36 monthsPercent
Length of stayFrom hospital admission at day 1 to hospital discharge or in-hospital death, assessed up to 36 monthsDays

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 1, 2026