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

Subarachnoid Hemorrhage Clinical Trial

— DON´T-PERISH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04063982
• Other study ID #: 008/19-ek
• Status: Recruiting
• Start date: December 12, 2019
• Est. completion date: December 2025

Study information

• Verified date: December 2023
• Source: University of Leipzig
• Contact: Katja E Wartenberg, MD
• Phone: +493419720072
• Email: katja.wartenberg[@]medizin.uni-leipzig.de
• Is FDA regulated: No
• Study type: Observational

Clinical 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. The scores and the assessment of the treating physicians and nurses are recorded on admission, at 7 and 14 days after symptom onset.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage
• Subarachnoid Hemorrhage

Intervention

Other:
• none, only assessment at different time points
assessment at different time points

Locations

Country	Name	City	State
Germany	Charité University Hospital	Berlin
Germany	University Hospital of Duesseldorf	Duesseldorf
Germany	University of Frankfurt	Frankfurt
Germany	Wolf-Dirk Niesen	Freiburg
Germany	University of Leipzig	Leipzig
Germany	University of Mainz	Mainz
Germany	Minden Hospital	Minden
Germany	LMU University of Munich	Munich
Germany	Osnabrueck Hospital	Osnabrück
Germany	University Hospital of Regensburg	Regensburg

Sponsors (2)

Lead Sponsor	Collaborator
University of Leipzig	German Society of Neurocritical Care

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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;	3 and 6 months