Diagnosis-related Outcomes in NeurocriTical Care: Prognostic Estimate by Health-care Providers Versus Risk Scores in Intracerebral and Subarachnoid Hemorrhage
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 1,085
- Locations
- 10
- Primary Endpoint
- Modified Rankin Scale dichotomized 0-2 versus 3-6 at 6 months
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- Modified Rankin Scale dichotomized 0-3 versus 4-6 at 6 months(6 months)
- Modified Rankin Scale dichotomized 0-3 versus 4-6 at 3 months(3 months)
- Quality of life measured by Short Form Health Survey Short Form (SF)-36(3 and 6 months)
- Quality of life measured by Sickness Impact Profile(3 and 6 months)
- Cognitive outcome Telephone Interview for Cognitive Status(3 and 6 months)
- Modified Rankin Scale dichotomized 0-2 versus 3-6 at 3 months(3 months)