Intracerebral Hemorrhage Trial - Nationwide record Trial, NRW
Recruiting
- Conditions
- I61.9Intracerebral haemorrhage, unspecified
- Registration Number
- DRKS00011098
- Lead Sponsor
- Klinik für Neurochirurgie, Universitätsklinikum Bonn
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 500
Inclusion Criteria
Patients must be = 18 years old,
- Written statement of consent and consent to participate at the Trial.
- Patients suffering from a new spontaneous intracerebral hemorrhage (ICH).
Exclusion Criteria
Injury of clinical inclusion criteria (eg traumatic genesis of hemorrhage , tumorous cause of hemorrhage)
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method eurological and clinical condition of the patients after 6 and 12 months, overall mortality and necessity of surgical revisions. The neurological grade of recovery of the patients will be analysed based on established and standardized neurological graduation scales (GOS, mRS, SF 12) 6 and 12 months after hemorrhage. Any individual cause of death within 6 and 12 month will be noticed. Analysis of risk profiles for surgically treated patients and Impact on outcome
- Secondary Outcome Measures
Name Time Method The aim of this observational study on patients with spontaneous ICH is to evaluate the collected information on the quality assurance of the therapeutic modalities and influence of several factors on outcome, e.g. Context of hemorrhage type (localization, size) and clinical outcome,<br>- influence of the selected Treatment strategy(conservative, surgical),<br>- effects of possible additional intensive-care modalities (e.g., blood pressure levels, transfusion of blood products and coagulation substitution)<br>- influence of the time factor up to hospitalization,<br>- Influence of additional procedures (external ventricular drainage, lumbar CSF drainage, VP shunt, decompressive hemikraniectomy),<br>- and their comparison,<br>- the balancing of the perioperative / postoperative risk of complications and<br>- clinical outcome for the assessment of the therapy<br>