Diagnosis-related Outcomes in NeurocriTical Care: Prognostic Estimate by Health-care Providers Versus Risk Scores in Intracerebral and Subarachnoid Hemorrhage (DON´T-PERISH)

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.

Study Overview

• Status: Completed
• Conditions: Subarachnoid Hemorrhage; Intracerebral Hemorrhage
• Intervention / Treatment: Other: none, only assessment at different time points

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 Type: Observational
• Enrollment (Actual): 1085

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• 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

Description

Inclusion Criteria:

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

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	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)	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.	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.	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.	3 and 6 months

Collaborators and Investigators

• Sponsor: University of Leipzig
• Collaborators: German Society of Neurocritical Care
• Investigators: Principal Investigator: Katja E Wartenberg, MD, University of Leipzig

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2019
• Primary Completion (Actual): February 28, 2025
• Study Completion (Actual): February 28, 2025

Study Registration Dates

• First Submitted: April 30, 2019
• First Submitted That Met QC Criteria: August 19, 2019
• First Posted (Actual): August 21, 2019

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: February 3, 2026
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Hemorrhage; Intracranial Hemorrhages; Pathological Conditions, Signs and Symptoms; Cerebral Hemorrhage; Subarachnoid Hemorrhage
• Other Study ID Numbers: 008/19-ek

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No