Prehospital and Acute Phase Characteristics of Severe Spontaneous ICH (NCT07739030) | Clinical Trial Compass
CompletedNot Applicable
Prehospital and Acute Phase Characteristics of Severe Spontaneous ICH
Denmark678 participantsStarted 2016-11-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this study has already been completed, would the findings about what happens in the first hours after a severe spontaneous brain bleed be relevant to my situation, and could you share what the results showed?
2This study tracked whether life-sustaining treatment was withdrawn early after a severe brain bleed — is that something that gets discussed routinely in cases like mine, and what factors would guide that decision for me specifically?
3The study measured functional status and mortality at 6 months after intracerebral hemorrhage — based on what it found about early characteristics, are there any signs in my case that point toward what my own 6-month outlook might look like?
4Since this was an observational study rather than a treatment trial, does it change or confirm anything about the standard care approach you would recommend for my type of brain bleed?
5This study focused on the prehospital and acute phase of severe spontaneous brain bleeds — does what happened in my case during those early hours match the patterns the study was looking at, and does that affect how you're planning my care?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Functional status at 6 months
Timeframe: Time Frame: From ictus onset of symptoms or last seen well to six months
2
Mortality at 6 months
Timeframe: From ictus to six months
3
Early withdrawal of life sustaining treatment
Timeframe: First 24 hours from admission to primary hospital