I60
Conditions
Interventions
Group 1: Primary decompressive craniectomy (PDC
within the first 24 hours after bleeding) combined with the best medical therapy including reinsertion of the cranial bone flap after approximately 90 days.
Group 2: Best possible neurointensive medic
Sponsors
Klinik und Poliklinik für Neurochirurgie
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Subjects will only be included in the study if they meet all of the fol-lowing criteria: - Male or female subjects, age = 18 years and = 80 years old - Aneurysmal subarachnoid hemorrhage - WFNS (grading system used to classify the severity of a sub-arachnoid hemorrhage based on the patients initial clinical condi-tion) grade 4 or 5 at admission - Operation can be performed within the first 24 hours after symp-toms of hemorrhage have started - Early aneurysm treatment must be deemed possible in order to perform primary decompressive craniectomy within 24h after symptoms of hemorrhage have started if randomized in arm A.
Exclusion criteria
Exclusion criteria: Subjects will not be included in the study if any of the following criteria applies: - Moribund patient (before subarachnoid hemorrhage) due to other illness - SAH due to any other cause than aneurysm rupture (traumatic, arteriovenous malformation (AVM), fistula, dissection) - Patients with foreseeable difficulties to perform the follow-up adequatelyin - Strong indication of inability (before aSAH) to understand and respond to questions in German - Any condition that, in the judgement of the Investigator, could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study - Patients with obvious evidence of irreparable brainstem or thalamic injury
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of the combination of mortality and severe disability be-tween study arms, assessed by the modified Rankin Scale (mRS; com-monly used scale for measuring the degree of disability or dependence in the daily activities of people after stroke) between both study arms 12 months after the subarachnoid hemorrhage. - dichotomized in “favoura-ble (mRS 0-4) versus “unfavourable “ (mRS 5-6) outcome. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 a) Analysis of mortality at 7 and 90 days and at 12 and 24 months 1 b) Comparison of date of death in patients with PDC vs. noPDC after aSAH 2 a) Comparison of length of ICU-stay in patients with PDC vs. noPDC after aSAH 2 b) Comparison of length of hospital stay in patients with PDC vs. noPDC after aSAH 3) Evaluation of the rate of secondary decompressive craniectomy due to intractably raised ICP. 4) Evaluation of use of duraplasty after craniectomy 5) Evaluation of correlation between size of craniectomy and clinical outcome 6) Rate of complications due to craniectomy assessed by adverse events 7) Analysis of mRS in patients with PDC vs. noPDC before aSAH and 10-14 days, 30 days, 90 days, 180 days and 2 years (long-term fol-low-up) after aSAH 8) Analysis of SF36 scores and EQ-ED scores in patients with PDC vs. noPDC 12 months after aSAH | — |
Countries
Germany
Contacts
Public ContactErdem Güresir
Klinik und Poliklinik für Neurochirurgie
Outcome results
None listed