Efficacy and safety of cilostazol-nimodipine combined therapy on delayed cerebral ischaemia after aneurysmal subarachnoid haemorrhage: a prospective, randomised, double-blinded, placebo-controlled trial protocol
Introduction Delayed cerebral ischaemia (DCI) due to cerebral vasospasm (cVS) remains the foremost contributor to morbidity and mortality following aneurysmal subarachnoid haemorrhage (aSAH). Past efforts in preventing and treating DCI have failed to make any significant progress. To date, our most...
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BMJ Publishing Group
2020-10-01
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| author | Chad F Claus Doris Tong Diana Sigler Matthew Bahoura Prashant Kelkar Boyd Richards Teck M Soo Troy Dawley Sina Rajamand Lucas Garmo |
| author_facet | Chad F Claus Doris Tong Diana Sigler Matthew Bahoura Prashant Kelkar Boyd Richards Teck M Soo Troy Dawley Sina Rajamand Lucas Garmo |
| author_sort | Chad F Claus |
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| description | Introduction Delayed cerebral ischaemia (DCI) due to cerebral vasospasm (cVS) remains the foremost contributor to morbidity and mortality following aneurysmal subarachnoid haemorrhage (aSAH). Past efforts in preventing and treating DCI have failed to make any significant progress. To date, our most effective treatment involves the use of nimodipine, a calcium channel blocker. Recent studies have suggested that cilostazol, a platelet aggregation inhibitor, may prevent cVS. Thus far, no study has evaluated the effect of cilostazol plus nimodipine on the rate of DCI following aSAH.Methods and analysis This is a multicentre, double-blinded, randomised, placebo-controlled superiority trial investigating the effect of cilostazol on DCI. Data concerning rates of DCI, symptomatic and radiographic vasospasm, length of intensive care unit stay, and long-term functional and quality-of-life (QoL) outcomes will be recorded. All data will be collected with the aim of demonstrating that the use of cilostazol plus nimodipine will safely decrease the incidence of DCI, and decrease the rates of both radiographic and symptomatic vasospasm with subsequent improvement in long-term functional and QoL outcomes when compared with nimodipine alone.Ethics and dissemination Ethical approval was obtained from all participating hospitals by the Ascension Providence Hospital Institutional Review Board. The results of this study will be submitted for publication in peer-reviewed journals.Trial registration number NCT04148105 |
| format | Article |
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| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-10-01 |
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| spelling | doaj-art-d24f0cdbbcc84566808536bee03a97d12025-08-20T03:48:42ZengBMJ Publishing GroupBMJ Open2044-60552020-10-01101010.1136/bmjopen-2019-036217Efficacy and safety of cilostazol-nimodipine combined therapy on delayed cerebral ischaemia after aneurysmal subarachnoid haemorrhage: a prospective, randomised, double-blinded, placebo-controlled trial protocolChad F Claus0Doris Tong1Diana Sigler2Matthew Bahoura3Prashant Kelkar4Boyd Richards5Teck M Soo6Troy Dawley7Sina Rajamand8Lucas Garmo9Division of Neurosurgery, Ascension Providence Hospital, Michigan State University, College of Human Medicine, Southfield, Michigan, USADivision of Neurosurgery, Ascension Providence Hospital, Michigan State University, College of Human Medicine, Southfield, Michigan, USADepartment of Pharmacy, Ascension Providence Hospital, Michigan State University, College of Human Medicine, Southfield, Michigan, USADivision of Neurosurgery, Ascension Providence Hospital, Michigan State University, College of Human Medicine, Southfield, Michigan, USADivision of Neurosurgery, Ascension Providence Hospital, Michigan State University, College of Human Medicine, Southfield, Michigan, USADivision of Neurosurgery, Ascension Providence Hospital, Michigan State University, College of Human Medicine, Southfield, Michigan, USADivision of Neurosurgery, Ascension Providence Hospital, Michigan State University, College of Human Medicine, Southfield, Michigan, USADivision of Neurosurgery, Ascension Providence Hospital, Michigan State University, College of Human Medicine, Southfield, Michigan, USADivision of Neurosurgery, Ascension Providence Hospital, Michigan State University, College of Human Medicine, Southfield, Michigan, USADivision of Neurosurgery, Ascension Providence Hospital, Michigan State University, College of Human Medicine, Southfield, Michigan, USAIntroduction Delayed cerebral ischaemia (DCI) due to cerebral vasospasm (cVS) remains the foremost contributor to morbidity and mortality following aneurysmal subarachnoid haemorrhage (aSAH). Past efforts in preventing and treating DCI have failed to make any significant progress. To date, our most effective treatment involves the use of nimodipine, a calcium channel blocker. Recent studies have suggested that cilostazol, a platelet aggregation inhibitor, may prevent cVS. Thus far, no study has evaluated the effect of cilostazol plus nimodipine on the rate of DCI following aSAH.Methods and analysis This is a multicentre, double-blinded, randomised, placebo-controlled superiority trial investigating the effect of cilostazol on DCI. Data concerning rates of DCI, symptomatic and radiographic vasospasm, length of intensive care unit stay, and long-term functional and quality-of-life (QoL) outcomes will be recorded. All data will be collected with the aim of demonstrating that the use of cilostazol plus nimodipine will safely decrease the incidence of DCI, and decrease the rates of both radiographic and symptomatic vasospasm with subsequent improvement in long-term functional and QoL outcomes when compared with nimodipine alone.Ethics and dissemination Ethical approval was obtained from all participating hospitals by the Ascension Providence Hospital Institutional Review Board. The results of this study will be submitted for publication in peer-reviewed journals.Trial registration number NCT04148105https://bmjopen.bmj.com/content/10/10/e036217.full |
| spellingShingle | Chad F Claus Doris Tong Diana Sigler Matthew Bahoura Prashant Kelkar Boyd Richards Teck M Soo Troy Dawley Sina Rajamand Lucas Garmo Efficacy and safety of cilostazol-nimodipine combined therapy on delayed cerebral ischaemia after aneurysmal subarachnoid haemorrhage: a prospective, randomised, double-blinded, placebo-controlled trial protocol BMJ Open |
| title | Efficacy and safety of cilostazol-nimodipine combined therapy on delayed cerebral ischaemia after aneurysmal subarachnoid haemorrhage: a prospective, randomised, double-blinded, placebo-controlled trial protocol |
| title_full | Efficacy and safety of cilostazol-nimodipine combined therapy on delayed cerebral ischaemia after aneurysmal subarachnoid haemorrhage: a prospective, randomised, double-blinded, placebo-controlled trial protocol |
| title_fullStr | Efficacy and safety of cilostazol-nimodipine combined therapy on delayed cerebral ischaemia after aneurysmal subarachnoid haemorrhage: a prospective, randomised, double-blinded, placebo-controlled trial protocol |
| title_full_unstemmed | Efficacy and safety of cilostazol-nimodipine combined therapy on delayed cerebral ischaemia after aneurysmal subarachnoid haemorrhage: a prospective, randomised, double-blinded, placebo-controlled trial protocol |
| title_short | Efficacy and safety of cilostazol-nimodipine combined therapy on delayed cerebral ischaemia after aneurysmal subarachnoid haemorrhage: a prospective, randomised, double-blinded, placebo-controlled trial protocol |
| title_sort | efficacy and safety of cilostazol nimodipine combined therapy on delayed cerebral ischaemia after aneurysmal subarachnoid haemorrhage a prospective randomised double blinded placebo controlled trial protocol |
| url | https://bmjopen.bmj.com/content/10/10/e036217.full |
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