Journal Article

PrImary decompressive Craniectomy in AneurySmal Subarachnoid hemOrrhage (PICASSO) trial: study protocol for a randomized controlled trial

Güresir, Erdem, Brandecker, Simon, Mielke, Dorothee, Czabanka, Marcus, Pala, Andrej, Haj, Amer, Németh, Robert, König, Ralph, Rohde, Veit, Fimmers, Rolf, Coch, Christoph, Haas, Patrick, Oppong, Marvin Darkwah, Wagner, Arthur, Kalasauskas, Darius, Prinz, Vincent, Schebesch, Karl-Michael, Lampmann, Tim, Ringel, Florian, Roder, Constantin, Jabbarli, Ramazan, Gempt, Jens, Vatter, Hartmut

2022

Overview

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. Trial registration DRKS DRKS00017650. Registered on 09 June 2019.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Aneurysms / Biomedicine / Care and treatment / Clinical trials / Decompressive craniectomy / Decompressive Craniectomy - adverse effects / Decompressive Craniectomy - methods / Diagnosis / Early brain injury / Health aspects / Health Sciences / Hemorrhage / Hospitals / Humans / Informed consent / Intracranial aneurysm / Intracranial Hypertension - diagnosis / Intracranial Hypertension - etiology / Intracranial Hypertension - surgery / Intracranial pressure / Measurement / Medical care / Medicine / Medicine & Public Health / Mortality / Multicenter Studies as Topic / Nervous system / Neurosurgery / Patients / Prevention / Prospective Studies / Quality management / Quality of Life / Randomized Controlled Trials as Topic / Randomized trial / Risk factors / Statistics for Life Sciences / Stroke / Stroke (Disease) / Study Protocol / Subarachnoid hemorrhage / Subarachnoid Hemorrhage - surgery / Surgery / Traumatic brain injury / Treatment Outcome