Intracerebral HaemorrhageNCT07739030
Prehospital and Acute Phase Characteristics of Severe Spontaneous ICH
An observational study of Intracerebral Haemorrhage and Intracerebral Haemorrhage, Intraventricular, run by Kirsten Moller at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracerebral Haemorrhage, Intracerebral Haemorrhage, Intraventricular, ICH - Intracerebral Hemorrhage
- How many people
- 678 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Nov 2016to 1 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Associations Between Prehospital Physiological Parameters and Functional Outcome in Severe Spontaneous Intracerebral Hemorrhage: a Retrospective Cohort Study
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.
Read the 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.
- Conditions
- Intracerebral Haemorrhage, Intracerebral Haemorrhage, Intraventricular, ICH - Intracerebral Hemorrhage, Spontaneous Intracerebral Hemorrhage
- Keywords
- Spontaneous ICH, Primary ICH, IVH, stroke, neurointensive care, Withdrawal of life sustaining treatment, functional outcome, Neurocritical care, Prehospital
- Medical subject headings
- Cerebral Hemorrhage, Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Time Frame: From ictus onset of symptoms or last seen well to six months
Mortality at 6 months
Percent
Measured: From ictus to six months
Early withdrawal of life sustaining treatment
Percent
Measured: First 24 hours from admission to primary hospital
Secondary outcomes (2)
In hospital death
Percent
Measured: From hospital admission at day 1 until any death date coinciding with hospital discharge, assessed up to 36 months
Length of stay
Days
Measured: From hospital admission at day 1 to hospital discharge or in-hospital death, assessed up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start1 Nov 2016
- Primary completion1 Nov 2025
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracerebral HaemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 678 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirsten Moller
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kirsten Moller, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07739030
- Sponsor's protocol ID
- p-2025-20339
- Other IDs
- R-25078842
- Status last verified
- Jul 2026
- First submitted
- 24 Jun 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Associations Between Prehospital Physiological Parameters and Functional Outcome in Severe Spontaneous Intracerebral Hemorrhage: a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07739030
- Acronym / sponsor ID
- p-2025-20339
- Conditions
- Intracerebral Haemorrhage, Intracerebral Haemorrhage, Intraventricular, ICH - Intracerebral Hemorrhage, Spontaneous Intracerebral Hemorrhage
- Keywords
- Spontaneous ICH, Primary ICH, IVH, stroke, neurointensive care, Withdrawal of life sustaining treatment, functional outcome, Neurocritical care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 678 participants (actual)
- Lead sponsor
- Kirsten MollerUniversity, hospital or other
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 31 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Mortality at 6 months
Time frame: From ictus to six months
Percent
Early withdrawal of life sustaining treatment
Time frame: First 24 hours from admission to primary hospital
Percent
2 secondary outcomes
In hospital death
Time frame: From hospital admission at day 1 until any death date coinciding with hospital discharge, assessed up to 36 months
Length of stay
Time frame: From hospital admission at day 1 to hospital discharge or in-hospital death, assessed up to 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracerebral Haemorrhage and Intracerebral Haemorrhage, Intraventricular, run by Kirsten Moller at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional status at 6 months (time frame: Time Frame: From ictus onset of symptoms or last seen well to six months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.