Comparing prognosis estimates for patients with brain hemorrhages
Diagnosis-related Outcomes in NeurocriTical Care: Prognostic Estimate by Health-care Providers Versus Risk Scores in Intracerebral and Subarachnoid Hemorrhage
University of Leipzig · NCT04063982
This study is trying to see if doctors' and nurses' predictions about recovery for patients with brain hemorrhages match up with established risk scores and actual patient outcomes over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Leipzig (other) |
| Locations | 10 sites (Berlin and 9 other locations) |
| Trial ID | NCT04063982 on ClinicalTrials.gov |
What this trial studies
This observational multicenter trial aims to compare the long-term prognosis estimates for patients suffering from intracerebral and subarachnoid hemorrhages as assessed by healthcare providers versus established clinical risk scores. Treating physicians and nurses will evaluate the functional and cognitive outcomes, as well as quality of life, at multiple time points: upon admission, and at 7 and 14 days post-symptom onset. The actual patient prognosis will be determined through follow-up interviews and questionnaires conducted at 3 and 6 months after the event.
Who should consider this trial
Good fit: Ideal candidates include individuals with spontaneous intracerebral hemorrhage or nontraumatic subarachnoid hemorrhage who are treated in specialized neurocritical care centers.
Not a fit: Patients with hemorrhages due to trauma or those who are admitted more than 48 hours after symptom onset may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of prognosis assessments for patients with brain hemorrhages, leading to better-informed treatment decisions.
How similar studies have performed: Other studies have shown success in using clinical risk scores for prognosis in similar conditions, indicating that this approach is supported by existing research.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Berlin and 9 other locations
- Charité University Hospital — Berlin, Germany (ACTIVE_NOT_RECRUITING)
- University Hospital of Duesseldorf — Duesseldorf, Germany (RECRUITING)
- University of Frankfurt — Frankfurt, Germany (RECRUITING)
- Wolf-Dirk Niesen — Freiburg, Germany (ACTIVE_NOT_RECRUITING)
- University of Leipzig — Leipzig, Germany (RECRUITING)
- University of Mainz — Mainz, Germany (RECRUITING)
- Minden Hospital — Minden, Germany (RECRUITING)
- LMU University of Munich — Munich, Germany (RECRUITING)
- Osnabrueck Hospital — Osnabrück, Germany (RECRUITING)
- University Hospital of Regensburg — Regensburg, Germany (RECRUITING)
Study contacts
- Principal investigator: Katja E Wartenberg, MD — University of Leipzig
- Study coordinator: Katja E Wartenberg, MD
- Email: katja.wartenberg@medizin.uni-leipzig.de
- Phone: +493419720072
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Intracerebral Hemorrhage, Subarachnoid Hemorrhage