NCT07739030

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
678

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 31, 2026

Completed
Last Updated

July 31, 2026

Status Verified

July 1, 2026

Enrollment Period

9 years

First QC Date

June 24, 2026

Last Update Submit

July 27, 2026

Conditions

Intracerebral HaemorrhageIntracerebral Haemorrhage, IntraventricularICH - Intracerebral HemorrhageSpontaneous Intracerebral Hemorrhage

Keywords

Spontaneous ICHPrimary ICHIVHstrokeneurointensive careWithdrawal of life sustaining treatmentfunctional outcomeNeurocritical carePrehospital

Outcome Measures

Primary Outcomes (3)

  • Functional status at 6 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

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

  • Mortality at 6 months

    Percent

    From ictus to six months

  • Early withdrawal of life sustaining treatment

    Percent

    First 24 hours from admission to primary hospital

Secondary Outcomes (2)

  • In hospital death

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

  • Length of stay

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study included all patients admitted to the neurointensive care unit at Copenhagen University Hospital Rigshospitalet, ≥18 years with primary spontaneous ICH from November 1, 2016, to October 1, 2025. Patients initially admitted to peripheral hospitals, including non-stroke units, prior to transfer were also eligible for inclusion.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Cerebral HemorrhageStroke

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

June 24, 2026

First Posted

July 31, 2026

Study Start

November 1, 2016

Primary Completion

November 1, 2025

Study Completion

April 1, 2026

Last Updated

July 31, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)