Intracerebral HemorrhageDON´T-PERISHNCT04063982
Diagnosis-related Outcomes in NeurocriTical Care: Prognostic Estimate by Health-care Providers Versus Risk Scores in Intracerebral and Subarachnoid Hemorrhage
An observational study of Intracerebral Hemorrhage and Subarachnoid Hemorrhage, run by University of Leipzig at 10 sites in Germany.
Trial summary
The aim of the observational multicenter trial encompasses the comparison of estimation of the long-term prognosis (functional and cognitive outcomes, quality of life) after intracerebral and subarachnoid hemorrhages assessed by clinical scores, treating physicians and nurses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracerebral Hemorrhage, Subarachnoid Hemorrhage
- What is being tested?
- none, only assessment at different time points
- How many people
- 1,085 participants
- Where
- 10 sitesGermany
- Study dates
- 12 Dec 2019to 28 Feb 2025
- 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: All patients admitted with acute spontaneous intracerebral and nontraumatic subarachnoid hemorrhage to a center with neurocritical care expertise
Who may be able to join
- Spontaneous intracerebral hemorrhage or nontraumatic subarachnoid hemorrhage
- Treatment in Centers with neurocritical care expertise
Who cannot join
- Language other than German and English
- Restriction of diagnostic and therapeutic measures during acute hospitalization according to advanced directives
- Admission > 48 hours after symptom onset
- Hemorrhage due to trauma
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Germany10 sites
Charité University Hospital
Berlin
University Hospital of Duesseldorf
Düsseldorf
University of Frankfurt
Frankfurt
Wolf-Dirk Niesen
Freiburg im Breisgau
University of Leipzig
Leipzig, 04103
University of Mainz
Mainz, 55131
Minden Hospital
Minden
LMU University of Munich
Munich
Osnabrueck Hospital
Osnabrück
University Hospital of Regensburg
Regensburg
About this study
The aim of the observational multicenter trial encompasses the comparison of estimation of the long-term prognosis (functional and cognitive outcomes, quality of life) after intracerebral and subarachnoid hemorrhages assessed by clinical scores, treating physicians and nurses. The scores and the assessment of the treating physicians and nurses are recorded on admission, at 7 and 14 days after symptom onset.
Read the detailed description
The physicians and nurses responsible for the individual patient's care will be given a questionaire. They are asked to estimate the functional and cognitive status as well as quality of life of their patient. The patient with intracerebral hemorrhage and subarachnoid hemorrhage is examined and assessed with respective established and validated prognostic scores and models at the same time points.
The actual prognosis is assessed by telephone interview and questionaires at 3 and 6 months, either from the patient or his/her caretaker.
- Conditions
- Intracerebral Hemorrhage, Subarachnoid Hemorrhage
- Being tested
- none, only assessment at different time points
- Medical subject headings
- Cerebral Hemorrhage, Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
none, only assessment at different time pointsOther
assessment at different time points
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin Scale dichotomized 0-2 versus 3-6 at 6 months
Modified Rankin Scale dichotomized 0-2 (good functional outcome) versus 3-6 (poor functional outcome)
Measured: 6 months
Secondary outcomes (6)
Modified Rankin Scale dichotomized 0-2 versus 3-6 at 3 months
Modified Rankin Scale dichotomized 0-2 (good functional outcome) versus 3-6 (poor functional outcome)
Measured: 3 months
Modified Rankin Scale dichotomized 0-3 versus 4-6 at 6 months
Modified Rankin Scale dichotomized 0-3 (good functional outcome) versus 4-6 (poor functional outcome)
Measured: 6 months
Modified Rankin Scale dichotomized 0-3 versus 4-6 at 3 months
Modified Rankin Scale dichotomized 0-3 (good functional outcome) versus 4-6 (poor functional outcome)
Measured: 3 months
Quality of life measured by Short Form Health Survey Short Form (SF)-36
Short Form Health Survey Short Form (SF)-36: Out of the 36 items, the following 8 subscales/dimensions are assessed and compared to the values of the normal Population: physical function (10 items), physical role function (4 items), physical pain (2 items), general perception of health status (5 items), vitality (4 items), social function and Integration (2 items), emotional role functioning (3 items), psychological well-being (5 items), Change of health status, compared to one year ago (1 item). The first 4 dimensions can be summarized to the physical sum scale, the second 4 items comprise the psychological sum scale.
Measured: 3 and 6 months
Quality of life measured by Sickness Impact Profile
Sickness Impact Profile: 189 items in 14 topic categories. The physical dimension score is obtained by adding the scale values for each item checked within categories body care and movement, mobility, and ambulation, dividing by the maximum possible dysfunction score for these categories, and then multiplying by 100; the psychosocial dimension score is obtained by adding the scale values for each item checked within categories emotional behavior, social interaction, alterness behavior, and communication, dividing by the maximum possible dysfunction score for these categories, and then multiplying by 100. The scores for the remaining categories are always calculated individually. The overall score for the SIP is calculated by adding the scale values for each item checked across all categories and dividing by the maximum possible dysfunction score for the SIP. This figure is then multiplied by 100 to obtain the SIP overall score.
Measured: 3 and 6 months
Cognitive outcome Telephone Interview for Cognitive Status
Telephone Interview for Cognitive Status: During the telephone interview scores for 22 questions are obtained and added to a total score. The qualitative interpretive ranges are 33-41: cognitive impairment unlikely; 26-32 cognitive impairment may be or may not be present dependent on patients's age, education, history, etc.; 21-25: mild cognitive impairment; </=20: moderate to severe cognitive impairment.
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2019
- Study start12 Dec 2019
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracerebral HemorrhageStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 1,085 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Collaborators
- German Society of Neurocritical Care
- Responsible party
- Sponsor
- Investigators
- Katja E Wartenberg, MD, Principal investigator, University of Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04063982
- Sponsor's protocol ID
- 008/19-ek
- Acronym
- DON´T-PERISH
- Status last verified
- Mar 2025
- First submitted
- 30 Apr 2019
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- 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 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis-related Outcomes in NeurocriTical Care: Prognostic Estimate by Health-care Providers Versus Risk Scores in Intracerebral and Subarachnoid Hemorrhage
- ClinicalTrials.gov ID
- NCT04063982
- Acronym / sponsor ID
- DON´T-PERISH / 008/19-ek
- Conditions
- Intracerebral Hemorrhage, Subarachnoid Hemorrhage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,085 participants (actual)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Collaborators
- German Society of Neurocritical Care
- Study start
- 12 Dec 2019 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 21 Aug 2019 (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.
The aim of the observational multicenter trial encompasses the comparison of estimation of the long-term prognosis (functional and cognitive outcomes, quality of life) after intracerebral and subarachnoid hemorrhages assessed by clinical scores, treating physicians and nurses. The scores and the assessment of the treating physicians and nurses are recorded on admission, at 7 and 14 days after symptom onset.
Detailed description
The physicians and nurses responsible for the individual patient's care will be given a questionaire. They are asked to estimate the functional and cognitive status as well as quality of life of their patient. The patient with intracerebral hemorrhage and subarachnoid hemorrhage is examined and assessed with respective established and validated prognostic scores and models at the same time points.
The actual prognosis is assessed by telephone interview and questionaires at 3 and 6 months, either from the patient or his/her caretaker.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted with acute spontaneous intracerebral and nontraumatic subarachnoid hemorrhage to a center with neurocritical care expertise
Key inclusion criteria (2 listed)
- Spontaneous intracerebral hemorrhage or nontraumatic subarachnoid hemorrhage
- Treatment in Centers with neurocritical care expertise
Key exclusion criteria (4 listed)
- Language other than German and English
- Restriction of diagnostic and therapeutic measures during acute hospitalization according to advanced directives
- Admission > 48 hours after symptom onset
- Hemorrhage due to trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| none, only assessment at different time pointsassessment at different time points | Other | – |
Primary outcome
Modified Rankin Scale dichotomized 0-2 versus 3-6 at 6 months
Time frame: 6 months
Modified Rankin Scale dichotomized 0-2 (good functional outcome) versus 3-6 (poor functional outcome)
6 secondary outcomes
Modified Rankin Scale dichotomized 0-2 versus 3-6 at 3 months
Time frame: 3 months
Modified Rankin Scale dichotomized 0-3 versus 4-6 at 6 months
Time frame: 6 months
Modified Rankin Scale dichotomized 0-3 versus 4-6 at 3 months
Time frame: 3 months
Quality of life measured by Short Form Health Survey Short Form (SF)-36
Time frame: 3 and 6 months
Quality of life measured by Sickness Impact Profile
Time frame: 3 and 6 months
Cognitive outcome Telephone Interview for Cognitive Status
Time frame: 3 and 6 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 5 Feb 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.
Katja E Wartenberg, MD principal investigator
University of Leipzig
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracerebral Hemorrhage and Subarachnoid Hemorrhage, run by University of Leipzig at 10 sites in Germany.
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 2 inclusion and 4 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 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany. 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?
Modified Rankin Scale dichotomized 0-2 versus 3-6 at 6 months (time frame: 6 months). 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 5 Feb 2026.