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

Recruiting

• Conditions: Subarachnoid Hemorrhage; Intracerebral Hemorrhage

• Registration Number: NCT04063982
• Lead Sponsor: University of Leipzig

Brief 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.

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 Timeline

• Study First Submitted: 2019-04-30
• Study First Submitted QC: 2019-08-19
• Study First Posted: 2019-08-21
• Study Start: 2019-12-12
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-05
• Last Update Posted: 2023-12-06
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Modified Rankin Scale dichotomized 0-2 versus 3-6 at 6 months	6 months	Modified Rankin Scale dichotomized 0-2 (good functional outcome) versus 3-6 (poor functional outcome)

Secondary Outcome Measures

Name	Time	Method
Modified Rankin Scale dichotomized 0-3 versus 4-6 at 6 months	6 months	Modified Rankin Scale dichotomized 0-3 (good functional outcome) versus 4-6 (poor functional outcome)
Modified Rankin Scale dichotomized 0-3 versus 4-6 at 3 months	3 months	Modified Rankin Scale dichotomized 0-3 (good functional outcome) versus 4-6 (poor functional outcome)
Quality of life measured by Short Form Health Survey Short Form (SF)-36	3 and 6 months	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.
Quality of life measured by Sickness Impact Profile	3 and 6 months	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.
Cognitive outcome Telephone Interview for Cognitive Status	3 and 6 months	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.
Modified Rankin Scale dichotomized 0-2 versus 3-6 at 3 months	3 months	Modified Rankin Scale dichotomized 0-2 (good functional outcome) versus 3-6 (poor functional outcome)

Trial Locations

Locations (10)

Osnabrueck Hospital; 🇩🇪 Osnabrück, Germany

University of Frankfurt; 🇩🇪 Frankfurt, Germany

University Hospital of Regensburg; 🇩🇪 Regensburg, Germany

Charité University Hospital; 🇩🇪 Berlin, Germany

LMU University of Munich; 🇩🇪 Munich, Germany

Minden Hospital; 🇩🇪 Minden, Germany

Wolf-Dirk Niesen; 🇩🇪 Freiburg, Germany

University Hospital of Duesseldorf; 🇩🇪 Duesseldorf, Germany

University of Leipzig; 🇩🇪 Leipzig, Germany

University of Mainz; 🇩🇪 Mainz, Germany