Clinical trial NCT04063982: Diagnosis-related Outcomes in NeurocriTical Care: Prognostic Estimate by Health-care Providers Versus Risk Scores in Intracerebral and Subarachnoid Hemorrhage
Official title: Diagnosis-related Outcomes in NeurocriTical Care: Prognostic Estimate by Health-care Providers Versus Risk Scores in Intracerebral and Subarachnoid Hemorrhage
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Intracerebral Hemorrhage
Subarachnoid Hemorrhage
Lead sponsor: University of Leipzig
Sponsor class: OTHER
Collaborators: name: German Society of Neurocritical Care
First posted: 2019-08-21
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Modified Rankin Scale dichotomized 0-2 versus 3-6 at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Modified Rankin Scale dichotomized 0-2 versus 3-6 at 3 months
timeFrame: 3 months
measure: Modified Rankin Scale dichotomized 0-3 versus 4-6 at 6 months
timeFrame: 6 months
measure: Modified Rankin Scale dichotomized 0-3 versus 4-6 at 3 months
timeFrame: 3 months
measure: Quality of life measured by Short Form Health Survey Short Form (SF)-36
timeFrame: 3 and 6 months
measure: Quality of life measured by Sickness Impact Profile
timeFrame: 3 and 6 months
measure: Cognitive outcome Telephone Interview for Cognitive Status
timeFrame: 3 and 6 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité University Hospital
city: Duesseldorf
country: Germany
facility: University Hospital of Duesseldorf
city: Frankfurt
country: Germany
facility: University of Frankfurt
city: Freiburg
country: Germany
facility: Wolf-Dirk Niesen
city: Leipzig
country: Germany
facility: University of Leipzig
city: Mainz
country: Germany
facility: University of Mainz
city: Minden
country: Germany
facility: Minden Hospital
city: Munich
country: Germany
facility: LMU University of Munich
city: Osnabrück
country: Germany
facility: Osnabrueck Hospital
city: Regensburg
country: Germany
facility: University Hospital of Regensburg
Study officials:
affiliation: University of Leipzig
name: Katja E Wartenberg, MD
role: PRINCIPAL_INVESTIGATOR
References: