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Open Access 01-12-2022 | Intracranial Aneurysm | Study protocol

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

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

Published in: Trials | Issue 1/2022

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.

Trial registration

DRKS DRKS00017650. Registered on 09 June 2019.

Available only for authorised users

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Title: PrImary decompressive Craniectomy in AneurySmal Subarachnoid hemOrrhage (PICASSO) trial: study protocol for a randomized controlled trial
Authors: Erdem Güresir
Tim Lampmann
Simon Brandecker
Marcus Czabanka
Rolf Fimmers
Jens Gempt
Patrick Haas
Amer Haj
Ramazan Jabbarli
Darius Kalasauskas
Ralph König
Dorothee Mielke
Robert Németh
Marvin Darkwah Oppong
Andrej Pala
Vincent Prinz
Florian Ringel
Constantin Roder
Veit Rohde
Karl-Michael Schebesch
Arthur Wagner
Christoph Coch
Hartmut Vatter
Publication date: 01-12-2022
Publisher: BioMed Central
Keywords: Intracranial Aneurysm
Subarachnoid Hemorrhage
Intracranial Hypertension
Subarachnoid Hemorrhage
Published in: Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-022-06969-4

Keynote webinar | Spotlight on medication adherence

Springer Medicine

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

Abstract

Background

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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