PrImary decompressive Craniectomy in AneurySmal Subarachnoid hemOrrhage (PICASSO) trial: study protocol for a randomized controlled trial
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PrImary decompressive Craniectomy in AneurySmal Subarachnoid hemOrrhage (PICASSO) trial: study protocol for a randomized controlled trial. / Güresir, Erdem; Lampmann, Tim; Brandecker, Simon; Czabanka, Marcus; Fimmers, Rolf; Gempt, Jens; Haas, Patrick; Haj, Amer; Jabbarli, Ramazan; Kalasauskas, Darius; König, Ralph; Mielke, Dorothee; Németh, Robert; Oppong, Marvin Darkwah; Pala, Andrej; Prinz, Vincent; Ringel, Florian; Roder, Constantin; Rohde, Veit; Schebesch, Karl-Michael; Wagner, Arthur; Coch, Christoph; Vatter, Hartmut.
In: TRIALS, Vol. 23, No. 1, 20.12.2022, p. 1027.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - PrImary decompressive Craniectomy in AneurySmal Subarachnoid hemOrrhage (PICASSO) trial: study protocol for a randomized controlled trial
AU - Güresir, Erdem
AU - Lampmann, Tim
AU - Brandecker, Simon
AU - Czabanka, Marcus
AU - Fimmers, Rolf
AU - Gempt, Jens
AU - Haas, Patrick
AU - Haj, Amer
AU - Jabbarli, Ramazan
AU - Kalasauskas, Darius
AU - König, Ralph
AU - Mielke, Dorothee
AU - Németh, Robert
AU - Oppong, Marvin Darkwah
AU - Pala, Andrej
AU - Prinz, Vincent
AU - Ringel, Florian
AU - Roder, Constantin
AU - Rohde, Veit
AU - Schebesch, Karl-Michael
AU - Wagner, Arthur
AU - Coch, Christoph
AU - Vatter, Hartmut
N1 - © 2022. The Author(s).
PY - 2022/12/20
Y1 - 2022/12/20
N2 - 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.
AB - 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.
KW - Humans
KW - Subarachnoid Hemorrhage/surgery
KW - Decompressive Craniectomy/adverse effects
KW - Prospective Studies
KW - Quality of Life
KW - Treatment Outcome
KW - Intracranial Hypertension/diagnosis
KW - Randomized Controlled Trials as Topic
KW - Multicenter Studies as Topic
U2 - 10.1186/s13063-022-06969-4
DO - 10.1186/s13063-022-06969-4
M3 - SCORING: Journal article
C2 - 36539817
VL - 23
SP - 1027
JO - TRIALS
JF - TRIALS
SN - 1745-6215
IS - 1
ER -
