Fight INflammation to Improve outcome after aneurysmal Subarachnoid HEmorRhage (FINISHER) trial: study protocol for a randomized controlled trial
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Fight INflammation to Improve outcome after aneurysmal Subarachnoid HEmorRhage (FINISHER) trial: study protocol for a randomized controlled trial. / Güresir, Erdem; Lampmann, Tim; Bele, Sylvia; Czabanka, Marcus; Czorlich, Patrick; Gempt, Jens; Goldbrunner, Roland; Hurth, Helene; Hermann, Elvis; Jabbarli, Ramazan; Krauthausen, Marius; König, Ralph; Lindner, Dirk; Malinova, Vesna; Meixensberger, Jürgen; Mielke, Dorothee; Németh, Robert; Darkwah Oppong, Marvin; Pala, Andrej; Prinz, Vincent; Rashidi, Ali; Roder, Constantin; Sandalcioglu, I Erol; Sauvigny, Thomas; Schebesch, Karl-Michael; Timmer, Marco; Vajkoczy, Peter; Wessels, Lars; Wild, Florian; Wilhelm, Christoph; Wostrack, Maria; Vatter, Hartmut; Coch, Christoph.
in: INT J STROKE, Jahrgang 18, Nr. 2, 02.2023, S. 242-247.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - Fight INflammation to Improve outcome after aneurysmal Subarachnoid HEmorRhage (FINISHER) trial: study protocol for a randomized controlled trial
AU - Güresir, Erdem
AU - Lampmann, Tim
AU - Bele, Sylvia
AU - Czabanka, Marcus
AU - Czorlich, Patrick
AU - Gempt, Jens
AU - Goldbrunner, Roland
AU - Hurth, Helene
AU - Hermann, Elvis
AU - Jabbarli, Ramazan
AU - Krauthausen, Marius
AU - König, Ralph
AU - Lindner, Dirk
AU - Malinova, Vesna
AU - Meixensberger, Jürgen
AU - Mielke, Dorothee
AU - Németh, Robert
AU - Darkwah Oppong, Marvin
AU - Pala, Andrej
AU - Prinz, Vincent
AU - Rashidi, Ali
AU - Roder, Constantin
AU - Sandalcioglu, I Erol
AU - Sauvigny, Thomas
AU - Schebesch, Karl-Michael
AU - Timmer, Marco
AU - Vajkoczy, Peter
AU - Wessels, Lars
AU - Wild, Florian
AU - Wilhelm, Christoph
AU - Wostrack, Maria
AU - Vatter, Hartmut
AU - Coch, Christoph
PY - 2023/2
Y1 - 2023/2
N2 - RATIONALE: Aneurysmal subarachnoid hemorrhage (SAH) has high morbidity and mortality. While the primary injury results from the initial bleeding cannot currently be influenced, secondary injury through vasospasm and delayed cerebral ischemia worsens outcome and might be a target for interventions to improve outcome. To date, beside the aneurysm treatment to prevent re-bleeding and the administration of oral nimodipine, there is no therapy available, so novel treatment concepts are needed. Evidence suggests that inflammation contributes to delayed cerebral ischemia and poor outcome in SAH. Some studies suggest a beneficial effect of anti-inflammatory glucocorticoids, but there are no data from randomized controlled trials examining the efficacy of glucocorticoids. Therefore, current guidelines do not recommend the use of glucocorticoids in SAH.AIM: The Fight INflammation to Improve outcome after aneurysmal Subarachnoid HEmorRhage (FINISHER) trial aims to determine whether dexamethasone improves outcome in a clinically relevant endpoint in SAH patients.METHODS AND DESIGN: FINISHER is a multicenter, prospective, randomized, double-blinded, placebo-controlled clinical phase III trial which is testing the outcome and safety of anti-inflammatory treatment with dexamethasone in SAH patients.SAMPLE SIZE ESTIMATES: In all, 334 patients will be randomized to either dexamethasone or placebo within 48 h after SAH. The dexamethasone dose is 8 mg tds for days 1-7 and then 8 mg od for days 8-21.STUDY OUTCOME: The primary outcome is the modified Rankin Scale (mRS) at 6 months, which is dichotomized to favorable (mRS 0-3) versus unfavorable (mRS 4-6).DISCUSSION: The results of this study will provide the first phase III evidence as to whether dexamethasone improves outcome in SAH.
AB - RATIONALE: Aneurysmal subarachnoid hemorrhage (SAH) has high morbidity and mortality. While the primary injury results from the initial bleeding cannot currently be influenced, secondary injury through vasospasm and delayed cerebral ischemia worsens outcome and might be a target for interventions to improve outcome. To date, beside the aneurysm treatment to prevent re-bleeding and the administration of oral nimodipine, there is no therapy available, so novel treatment concepts are needed. Evidence suggests that inflammation contributes to delayed cerebral ischemia and poor outcome in SAH. Some studies suggest a beneficial effect of anti-inflammatory glucocorticoids, but there are no data from randomized controlled trials examining the efficacy of glucocorticoids. Therefore, current guidelines do not recommend the use of glucocorticoids in SAH.AIM: The Fight INflammation to Improve outcome after aneurysmal Subarachnoid HEmorRhage (FINISHER) trial aims to determine whether dexamethasone improves outcome in a clinically relevant endpoint in SAH patients.METHODS AND DESIGN: FINISHER is a multicenter, prospective, randomized, double-blinded, placebo-controlled clinical phase III trial which is testing the outcome and safety of anti-inflammatory treatment with dexamethasone in SAH patients.SAMPLE SIZE ESTIMATES: In all, 334 patients will be randomized to either dexamethasone or placebo within 48 h after SAH. The dexamethasone dose is 8 mg tds for days 1-7 and then 8 mg od for days 8-21.STUDY OUTCOME: The primary outcome is the modified Rankin Scale (mRS) at 6 months, which is dichotomized to favorable (mRS 0-3) versus unfavorable (mRS 4-6).DISCUSSION: The results of this study will provide the first phase III evidence as to whether dexamethasone improves outcome in SAH.
U2 - 10.1177/17474930221093501
DO - 10.1177/17474930221093501
M3 - SCORING: Journal article
C2 - 35361026
VL - 18
SP - 242
EP - 247
JO - INT J STROKE
JF - INT J STROKE
SN - 1747-4930
IS - 2
ER -
