Skip to main content
OpenTrials
Completed

NCT Number: NCT07739030

Prehospital and Acute Phase Characteristics of Severe Spontaneous ICH

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Intracerebral Haemorrhage Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Hemorrhage Cerebrovascular Disorders Hemorrhage ICH - Intracerebral Hemorrhage Intracerebral Haemorrhage, Intraventricular Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Spontaneous Intracerebral Hemorrhage Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rigshospitalet

Copenhagen, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Functional status at 6 months

    Time frame: Time Frame: From ictus onset of symptoms or last seen well to six months

    Modified 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

  2. Mortality at 6 months

    Time frame: From ictus to six months

    Percent

  3. Early withdrawal of life sustaining treatment

    Time frame: First 24 hours from admission to primary hospital

    Percent

Secondary outcomes

  1. In hospital death

    Time frame: From hospital admission at day 1 until any death date coinciding with hospital discharge, assessed up to 36 months

    Percent

  2. Length of stay

    Time frame: From hospital admission at day 1 to hospital discharge or in-hospital death, assessed up to 36 months

    Days

Sponsors and collaborators

Lead sponsor

Kirsten Moller

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2025
Study completion
2026
First posted
Jul 31, 2026
Registry last updated
Jul 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.