Ignite Creation Date:
2024-05-06 @ 6:59 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05851989
Status:
RECRUITING
Last Update Posted:
2023-05-10
First Post:
2023-02-22
Brief Title:
Study on Prognosis of Acutely Ruptured Intracranial Aneurysms
Sponsor:
Haaglanden Medical Centre
Organization:
Haaglanden Medical Centre
Study Overview
Official Title:
Study on Prognosis of Acutely Ruptured Intracranial Aneurysms
Status:
RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPARTA
Brief Summary:
The SPARTA study is a prospective multicenter observational trial in the Netherlands with the aim of identifying the best clinical care in patients with aneurysmal subarachnoidal haemorrhage Differences in outcome between surgical treatment and endovascular treatment will be explored
Furthermore cost effectiveness and radiological prognostic factors will be examined
Furthermore cost effectiveness and radiological prognostic factors will be examined
Detailed Description:
Rationale
Ruptured intracranial aneurysms resulting in subarachnoid haemorrhage can be treated by open surgical treatment or endovascular treatment Despite multiple previous studies biases and uncertainty around the best current treatment practice still exist The resulting variation of care may result in a variable outcome The protocol for a prospective multicentre observational study aimed at comparing the effectiveness of different treatment strategies in patients with ruptured aneurysms is presented
Objective
The primary aim of this study is to identify the effectiveness of clipping versus coiling on functional outcome in patients presenting with a subarachnoid haemorrhage due to a ruptured intracranial aneurysm 1 year after onset of symptoms Secondary objectives include long term functional outcome complications cost-effectiveness and explorative analysis of the diagnostic and prognostic value of radiological imaging
Study design
This multi-centre study will have an observational prospective cohort design Patient will have a follow-up of maximum 10 years
Study population
Patients with a subarachnoid haemorrhage will be included Patients with evident other causes and patients without diagnosis of intracranial aneurysm after six months will be excluded
Main study parametersendpoints
The primary endpoint is the score on the modified Rankin scale mRs and mortality at 1 year after the initial SAH Secondary endpoints include the mRs Modified Telephone Interview of Cognitive Status TICS-M 5-level EuroQol-5D EQ-5D-5L and derived Quality of Life Years costs from patient diaries and the Hospital Anxiety and Depression Scale HADS measured at 6 months 1 2 5 and 10 years
Nature and extent of the burden and risks associated with participation benefit and group relatedness
Patients will receive nonexperimental regular care during their hospital stay For this study health questionnaires and functional outcome will be assessed at baseline follow-up visits and before discharge Temporary fatigue is the only possible side-effect of completion of the questionnaires
Ruptured intracranial aneurysms resulting in subarachnoid haemorrhage can be treated by open surgical treatment or endovascular treatment Despite multiple previous studies biases and uncertainty around the best current treatment practice still exist The resulting variation of care may result in a variable outcome The protocol for a prospective multicentre observational study aimed at comparing the effectiveness of different treatment strategies in patients with ruptured aneurysms is presented
Objective
The primary aim of this study is to identify the effectiveness of clipping versus coiling on functional outcome in patients presenting with a subarachnoid haemorrhage due to a ruptured intracranial aneurysm 1 year after onset of symptoms Secondary objectives include long term functional outcome complications cost-effectiveness and explorative analysis of the diagnostic and prognostic value of radiological imaging
Study design
This multi-centre study will have an observational prospective cohort design Patient will have a follow-up of maximum 10 years
Study population
Patients with a subarachnoid haemorrhage will be included Patients with evident other causes and patients without diagnosis of intracranial aneurysm after six months will be excluded
Main study parametersendpoints
The primary endpoint is the score on the modified Rankin scale mRs and mortality at 1 year after the initial SAH Secondary endpoints include the mRs Modified Telephone Interview of Cognitive Status TICS-M 5-level EuroQol-5D EQ-5D-5L and derived Quality of Life Years costs from patient diaries and the Hospital Anxiety and Depression Scale HADS measured at 6 months 1 2 5 and 10 years
Nature and extent of the burden and risks associated with participation benefit and group relatedness
Patients will receive nonexperimental regular care during their hospital stay For this study health questionnaires and functional outcome will be assessed at baseline follow-up visits and before discharge Temporary fatigue is the only possible side-effect of completion of the questionnaires
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None