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CompletedNCT04063982DON´T-PERISHUpdated Feb 5, 2026

Diagnosis-related Outcomes in NeurocriTical Care: Prognostic Estimate by Health-care Providers Versus Risk Scores in Intracerebral and Subarachnoid Hemorrhage

An observational study in Intracerebral Hemorrhage and Subarachnoid Hemorrhage, sponsored by University of Leipzig. Completed at 10 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-05.

Sponsored by University of Leipzig · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
1,085
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Intracerebral Hemorrhage
  • Subarachnoid Hemorrhage
03

In context

Cerebral Hemorrhage

476 studies on the registry are indexed under Cerebral Hemorrhage; 181 are open to participants now.

This study's enrollment of 1,085 is above the median of 275 across 180 observational studies indexed under Cerebral Hemorrhage.

Browse Cerebral Hemorrhage studies →

Lead sponsor

University of Leipzig is the lead sponsor of 147 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patients admitted with acute spontaneous intracerebral and nontraumatic subarachnoid hemorrhage to a center with neurocritical care expertise

Inclusion criteria

  • Spontaneous intracerebral hemorrhage or nontraumatic subarachnoid hemorrhage
  • Treatment in Centers with neurocritical care expertise

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
1,085 participants (actual)
Patient registry
No

Interventions

  • Othernone, only assessment at different time points

    assessment at different time points

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 6 months

Secondary outcomes

  1. 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)

    Time frame: 3 months

  2. 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)

    Time frame: 6 months

  3. 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)

    Time frame: 3 months

  4. 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.

    Time frame: 3 and 6 months

  5. 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.

    Time frame: 3 and 6 months

  6. 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.

    Time frame: 3 and 6 months

07

Study locations

10 sites
  • Charité University Hospital
    Berlin, Germany
  • University Hospital of Duesseldorf
    Düsseldorf, Germany
  • University of Frankfurt
    Frankfurt, Germany
  • Wolf-Dirk Niesen
    Freiburg im Breisgau, Germany
  • University of Leipzig
    Leipzig, 04103, Germany
  • University of Mainz
    Mainz, 55131, Germany
  • Minden Hospital
    Minden, Germany
  • LMU University of Munich
    Munich, Germany
  • Osnabrueck Hospital
    Osnabrück, Germany
  • University Hospital of Regensburg
    Regensburg, Germany
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04063982
Lead sponsor
University of Leipzig
Collaborators
German Society of Neurocritical Care
Responsible party
Sponsor
First posted
Aug 21, 2019
Start date
Dec 12, 2019
Primary completion
Feb 28, 2025
Completion
Feb 28, 2025
Last update
Feb 5, 2026

Study contacts

Katja E Wartenberg, MD
principal investigator · University of Leipzig

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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