TY - JOUR
T1 - Study on prognosis of acutely ruptured intracranial aneurysms (SPARTA)
T2 - a protocol for a multicentre prospective cohort study
AU - Hamming, Alexander L.
AU - van Dijck, Jeroen T.J.M.
AU - Visser, Tjitske
AU - Baarse, Martine
AU - Verbaan, Dagmar
AU - Schenck, Hanna
AU - Haeren, Roel H.L.
AU - Fakhry, Rahman
AU - Dammers, Ruben
AU - Aquarius, René
AU - Boogaarts, Jeroen H.D.
AU - Peul, Wilco C.
AU - Moojen, Wouter A.
N1 - Funding Information:
The authors would like to thank Finn Seghers (Department of Internal Medicine, UZ Leuven, Belgium) and Thomas de Korte (Department of Radiology, Meander Medical Centre Groningen, The Netherlands) for their input in writing this study protocol.
Funding Information:
This study is sponsored by the Sint Jacobus Stichting, a non-profit organisation. The sponsor has no role in the design of the study and the collection, analysis and interpretation of data.
Publisher Copyright:
© The Author(s) 2024.
PY - 2024/2/17
Y1 - 2024/2/17
N2 - BACKGROUND: Ruptured intracranial aneurysms resulting in subarachnoid haemorrhage can be treated by open surgical or endovascular treatment. Despite multiple previous studies, uncertainties on the optimal treatment practice still exists. The resulting treatment variation may result in a variable, potentially worse, patient outcome. To better inform future treatment strategies, this study aims to identify the effectiveness of different treatment strategies in patients with ruptured intracranial aneurysms by investigating long-term functional outcome, complications and cost-effectiveness. An explorative analysis of the diagnostic and prognostic value of radiological imaging will also be performed. METHODS: This multi-centre observational prospective cohort study will have a follow-up of 10 years. A total of 880 adult patients with a subarachnoid haemorrhage caused by a ruptured intracranial aneurysm will be included. Calculation of sample size (N?=?880) was performed to show non-inferiority of clip-reconstruction compared to endovascular treatment on 1 year outcome, assessed by using the ordinal modified Rankin Scale. The primary endpoint is the modified Rankin Scale score and mortality at 1 year after the initial subarachnoid haemorrhage. Patients will receive 'non-experimental' regular care during their hospital stay. For this study, health questionnaires and functional outcome will be assessed at baseline, before discharge and at follow-up visits. DISCUSSION: Despite the major healthcare and societal burden, the optimal treatment strategy for patients with subarachnoid haemorrhage caused by ruptured intracranial aneurysms is yet to be determined. Findings of this comparative effectiveness study, in which in-between centre variation in practice and patient outcome are investigated, will provide evidence on the effectiveness of treatment strategies, hopefully contributing to future high value treatment standardisation. TRIAL REGISTRATION NUMBER: NCT05851989 DATE OF REGISTRATION: May 10th, 2023.
AB - BACKGROUND: Ruptured intracranial aneurysms resulting in subarachnoid haemorrhage can be treated by open surgical or endovascular treatment. Despite multiple previous studies, uncertainties on the optimal treatment practice still exists. The resulting treatment variation may result in a variable, potentially worse, patient outcome. To better inform future treatment strategies, this study aims to identify the effectiveness of different treatment strategies in patients with ruptured intracranial aneurysms by investigating long-term functional outcome, complications and cost-effectiveness. An explorative analysis of the diagnostic and prognostic value of radiological imaging will also be performed. METHODS: This multi-centre observational prospective cohort study will have a follow-up of 10 years. A total of 880 adult patients with a subarachnoid haemorrhage caused by a ruptured intracranial aneurysm will be included. Calculation of sample size (N?=?880) was performed to show non-inferiority of clip-reconstruction compared to endovascular treatment on 1 year outcome, assessed by using the ordinal modified Rankin Scale. The primary endpoint is the modified Rankin Scale score and mortality at 1 year after the initial subarachnoid haemorrhage. Patients will receive 'non-experimental' regular care during their hospital stay. For this study, health questionnaires and functional outcome will be assessed at baseline, before discharge and at follow-up visits. DISCUSSION: Despite the major healthcare and societal burden, the optimal treatment strategy for patients with subarachnoid haemorrhage caused by ruptured intracranial aneurysms is yet to be determined. Findings of this comparative effectiveness study, in which in-between centre variation in practice and patient outcome are investigated, will provide evidence on the effectiveness of treatment strategies, hopefully contributing to future high value treatment standardisation. TRIAL REGISTRATION NUMBER: NCT05851989 DATE OF REGISTRATION: May 10th, 2023.
KW - Aneurysmal subarachnoid haemorrhage
KW - Clip-reconstruction
KW - Comparative effectiveness
KW - Cost-effectiveness
KW - Endovascular treatment
KW - Long-term outcome
KW - Neurosurgery
KW - Ruptured intracranial aneurysm
U2 - 10.1186/s12883-024-03567-6
DO - 10.1186/s12883-024-03567-6
M3 - Article
SN - 1471-2377
VL - 24
JO - BMC Neurology
JF - BMC Neurology
IS - 1
M1 - 68
ER -