Guresir, Erdem and Lampmann, Tim and Brandecker, Simon and Czabanka, Marcus and Fimmers, Rolf and Gempt, Jens and Haas, Patrick and Haj, Amer and Jabbarli, Ramazan and Kalasauskas, Darius and Konig, Ralph and Mielke, Dorothee and Nemeth, Robert and Oppong, Marvin Darkwah and Pala, Andrej and Prinz, Vincent and Ringel, Florian and Roder, Constantin and Rohde, Veit and Schebesch, Karl-Michael and Wagner, Arthur and Coch, Christoph and Vatter, Hartmut (2022) PrImary decompressive Craniectomy in AneurySmal Subarachnoid hemOrrhage (PICASSO) trial: study protocol for a randomized controlled trial. TRIALS, 23 (1): 1027. ISSN , 1745-6215
Full text not available from this repository. (Request a copy)Abstract
Background: Poor-grade aneurysmal subarachnoid hemorrhage (SAH) is associated with poor neurological outcome and high mortality. A major factor influencing morbidity and mortality is brain swelling in the acute phase. Decompressive craniectomy (DC) is currently used as an option in order to reduce intractably elevated intracranial pressure (ICP). However, execution and optimal timing of DC remain unclear. Methods: PICASSO resembles a multicentric, prospective, 1:1 randomized standard treatment-controlled trial which analyzes whether primary DC (pDC) performed within 24 h combined with the best medical treatment in patients with poor-grade SAH reduces mortality and severe disability in comparison to best medical treatment alone and secondary craniectomy as ultima ratio therapy for elevated ICP. Consecutive patients presenting with poor-grade SAH, defined as grade 4-5 according to the World Federation of Neurosurgical Societies (WFNS), will be screened for eligibility. Two hundred sixteen patients will be randomized to receive either pDC additional to best medical treatment or best medical treatment alone. The primary outcome is the clinical outcome according to the modified Rankin Scale (mRS) at 12 months, which is dichotomized to favorable (mRS 0-4) and unfavorable (mRS 5-6). Secondary outcomes include morbidity and mortality, time to death, length of intensive care unit (ICU) stay and hospital stay, quality of life, rate of secondary DC due to intractably elevated ICP, effect of size of DC on outcome, use of duraplasty, and complications of DC. Discussion: This multicenter trial aims to generate the first confirmatory data in a controlled randomized fashion that pDC improves the outcome in a clinically relevant endpoint in poor-grade SAH patients.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | MIDDLE CEREBRAL-ARTERY; INTRACRANIAL HYPERTENSION; INTRACEREBRAL HEMORRHAGE; HEMICRANIECTOMY; INFARCTION; Early brain injury; Intracranial pressure; Decompressive craniectomy; Subarachnoid hemorrhage; Intracranial aneurysm; Randomized trial |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Neurochirurgie |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 31 Jan 2024 13:57 |
| Last Modified: | 31 Jan 2024 13:57 |
| URI: | https://pred.uni-regensburg.de/id/eprint/58589 |
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