Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06621407
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-19
Brief Title:
A National Study Examining the Most Effective Drainage Method After Burr Hole Evacuation of Chronic Subdural Hematoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Active 24 Hours Subperiostal Vs 24 Hours Passive Subdural Drainage Following Burr Hole Evacuation of Chronic Subdural Hematoma the SUPERDURA Trial - Protocol for a Nationwide Randomized Clinical Non-inferiority Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SUPERDURA
Brief Summary:
Chronic subdural hematoma CSDH is a common disease The main treatment is neurosurgical evacuation and subsequent hematoma drainage However consensus on the optimal drain placement site and whether the drainage should be active or passive is lacking
The aim of the current study is to test the hypothesis that 24 hours active subperiosteal drainage is non-inferior to 24 hours passive subdural drainage after single burr hole evacuation of a unilateral CSDH
The study will be conducted as a randomized multicenter trial encompassing all neurosurgical units in Denmark All adult patients with symptomatic unilateral CSDH admitted to a Danish neurosurgical unit for single burr hole evacuation will be considered for inclusion Exclusion criteria are mental incapacitation bilateral CSDH recurrent CSDH known cerebrospinal fluid abnormalities and other known brain pathologies
Before surgical hematoma evacuation patients will be randomized to 24 hours passive subdural drainage or 24 hours active subperiostal drainage and the drain placed accordingly at the end of the hematoma evacuation procedure
The surgeons performing the procedure and the nurses handling the drains will not be blinded The patients outcome assessors at 3-months follow-up and statisticians will be blinded
The primary end point is a composite outcome of 90-day mortality and recurrent CSDH on the same side as the primary operation requiring reoperation within the 90-day follow-up period
Secondary outcomes are complications related to surgery and 90-day modified Rankin score
By statistical analysis the investigators estimate that 598 patients will be required to demonstrate a relative risk reduction of recurrent CSDH and mortality of 30 for the cohort receiving active subperiostal drainage given a stable power above 80 with an alpha of 5 Thus the study inclusion period is estimated to 2-3 years
Ethics approval for inclusion of competent patients has been obtained N-20240009
The aim of the current study is to test the hypothesis that 24 hours active subperiosteal drainage is non-inferior to 24 hours passive subdural drainage after single burr hole evacuation of a unilateral CSDH
The study will be conducted as a randomized multicenter trial encompassing all neurosurgical units in Denmark All adult patients with symptomatic unilateral CSDH admitted to a Danish neurosurgical unit for single burr hole evacuation will be considered for inclusion Exclusion criteria are mental incapacitation bilateral CSDH recurrent CSDH known cerebrospinal fluid abnormalities and other known brain pathologies
Before surgical hematoma evacuation patients will be randomized to 24 hours passive subdural drainage or 24 hours active subperiostal drainage and the drain placed accordingly at the end of the hematoma evacuation procedure
The surgeons performing the procedure and the nurses handling the drains will not be blinded The patients outcome assessors at 3-months follow-up and statisticians will be blinded
The primary end point is a composite outcome of 90-day mortality and recurrent CSDH on the same side as the primary operation requiring reoperation within the 90-day follow-up period
Secondary outcomes are complications related to surgery and 90-day modified Rankin score
By statistical analysis the investigators estimate that 598 patients will be required to demonstrate a relative risk reduction of recurrent CSDH and mortality of 30 for the cohort receiving active subperiostal drainage given a stable power above 80 with an alpha of 5 Thus the study inclusion period is estimated to 2-3 years
Ethics approval for inclusion of competent patients has been obtained N-20240009
Detailed Description:
The incidence of symptomatic chronic subdural hematoma CSDH is sharply on the rise due to an ageing population and population risk factors such as alcohol misuse falls and use of anticoagulants and -platelets The treatment of symptomatic CSDH is neurosurgical hematoma evacuation followed by drain placement to facilitate subsequent postoperative drainage Accordingly in many general neurosurgical departments this is the most common cranial procedure performed on a daily basis However no consensus exists on the actual surgical technique hematoma evacuation by one burr hole more burr holes or a larger cranial opening craniotomy hematoma irrigation method drain placement site subdural or subperiostal and drainage method time active versus passive This was also the case in Denmark where the actual CDSH evacuation technique differed vastly between departments and between neurosurgeons at the same department although there only were four neurosurgical units in Denmark treating patients with symptomatic CSDH Accordingly in 2012 on the initiative of the four Danish neurosurgical departments the Danish Chronic Subdural Hematoma group DACSUHS was established in order to generate evidence based guidelines for the treatment of CSDH standardize the treatment and conduct national multicenter CSDH research The first national CSDH treatment guideline was based on data collected retrospectively from 2010 to 2012 rigorous literature search and a concluding Delphi process in the DACSUHS consortium before it was finally published in 2018 It reflects the best available evidence regarding 10 aspects of CSDH management including preoperative evaluation surgical approach postoperative mobilization and use of postoperative head CT Furthermore it enabled the standardization of the CSDH treatment in all Danish departments by requiring the use of the same operative technique drains fixation technique for drains and written patient information The standardized CSDH approach enabled also the initiation of two larger prospective national multicenter trials evaluating the optimal postoperative drainage time in relation to CSDH recurrence rate and patient mortality These above-mentioned process steps haves resulted in the current Danish CSDH treatment algorithm recommending evacuation of symptomatic CSDH by a single perforator made 13-mm burr hole above the maximum width of the hematoma followed by subdural temperate saline irrigation and subsequent placement of a subdural drain for 24 hours
The subdural drain placement has however been much debated as drain placement through the skull burr hole in the subdural space in direct proximity to the brain may result in brain lesions bleeding seizures and intracranial infections
Therefore burr hole craniostomy with subperiosteal drainage also known as subgaleal drainage has been suggested as an equally safe and effective treatment of CSDH due to less invasiveness and lower risk of drain inflicted brain parenchyma injury
Neurosurgeons have generally been reluctant to use active vacuum drainage on subdural drains due to their proximity to the brain whereas active drainage is more common active with subperiostal drainage has been more common Although a direct comparison is lacking it has been shown in a paper comparing three different Scandinavian centers using active subperiostal drainage passive subdural drainage and subdural drainage with continuously irrigation that patients receiving passive drainage had the highest recurrence rate 20 vs 11 and on average a slightly higher complication rate 81 vs 73 and mortality rate 73 vs 58 compared to active subperiostal drainage which had a recurrence rate of 111 and a complication and mortality rate of 73 and 58 respectively Similarly Post-hoc analysis of the cSDH-Drain and the TOSCAN studies have likewise revealed a higher recurrence rate 231 vs 141 in patients receiving passive compared to active drainage
Accordingly as active subperiostal drainage might seem to be more safe and more efficient the investigators find it justified to examine if 24 hours active subperiostal drainage is non-inferior to our current gold standard of 24 hours passive subdural drainage in a randomized clinical trial the SuperDura trial The obtained results from the SuperDura trial will not only have major relevance for neurosurgical praxis as the investigators perform the first direct comparison between two commonly used drainage methods on a national level
The subdural drain placement has however been much debated as drain placement through the skull burr hole in the subdural space in direct proximity to the brain may result in brain lesions bleeding seizures and intracranial infections
Therefore burr hole craniostomy with subperiosteal drainage also known as subgaleal drainage has been suggested as an equally safe and effective treatment of CSDH due to less invasiveness and lower risk of drain inflicted brain parenchyma injury
Neurosurgeons have generally been reluctant to use active vacuum drainage on subdural drains due to their proximity to the brain whereas active drainage is more common active with subperiostal drainage has been more common Although a direct comparison is lacking it has been shown in a paper comparing three different Scandinavian centers using active subperiostal drainage passive subdural drainage and subdural drainage with continuously irrigation that patients receiving passive drainage had the highest recurrence rate 20 vs 11 and on average a slightly higher complication rate 81 vs 73 and mortality rate 73 vs 58 compared to active subperiostal drainage which had a recurrence rate of 111 and a complication and mortality rate of 73 and 58 respectively Similarly Post-hoc analysis of the cSDH-Drain and the TOSCAN studies have likewise revealed a higher recurrence rate 231 vs 141 in patients receiving passive compared to active drainage
Accordingly as active subperiostal drainage might seem to be more safe and more efficient the investigators find it justified to examine if 24 hours active subperiostal drainage is non-inferior to our current gold standard of 24 hours passive subdural drainage in a randomized clinical trial the SuperDura trial The obtained results from the SuperDura trial will not only have major relevance for neurosurgical praxis as the investigators perform the first direct comparison between two commonly used drainage methods on a national level
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None