A National Study Examining the Most Effective Drainage Method After Burr Hole Evacuation of Chronic Subdural Hematoma

Not Applicable

Not yet recruiting

• Conditions: Chronic Subdural Hematoma; Surgical Procedures, Operative; Recurrence; Mortality; Drainage; Drainage/methods; Drainage Procedure
• Interventions: Procedure: 24 hours active subperiostal drainage; Procedure: 24 hours passive subdural drainage

• Registration Number: NCT06621407
• Lead Sponsor: Aalborg University Hospital

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).

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 (8.1% vs. 7.3%) and mortality rate (7.3% vs. 5.8%) compared to active subperiostal drainage which had a recurrence rate of 11.1% and a complication and mortality rate of 7.3% and 5.8%, respectively. Similarly, Post-hoc analysis of the cSDH-Drain and the TOSCAN studies have likewise revealed a higher recurrence rate (23.1% vs 14.1%) 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 Timeline

• Study First Submitted: 2024-09-19
• Study First Submitted QC: 2024-09-28
• Status Verified: 2024-10
• Study First Posted: 2024-10-01
• Last Update Submitted: 2024-10-19
• Last Update Posted: 2024-10-23
• Study Start: 2024-12
• Primary Completion: 2027-11
• Study Completion: 2028-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 598

Inclusion Criteria

• Adult patients (≥ 18 years).
• Patients with symptomatic CSDH confirmed on brain CT- or magnetic resonance imaging (MRI), admitted to a Danish neurosurgical department for surgical treatment.
• Patients undergoing a single burr-hole evacuation.
• Informed written and oral consent is taken prior to surgery.

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Exclusion Criteria

• Patients who are mentally incapacitated
• Patients with known abnormalities in their cerebrospinal fluid (protein and glucose levels, cell count, and type)
• Patients with changes or abnormalities in their normal cerebrospinal fluid dynamics, e.g., obstructive hydrocephalus, normal pressure hydrocephalus, intracranial hypotension, and ventricular peritoneal shunt.
• Patients with additional/previously intracranial pathology that requires/has required neurosurgical treatment (e.g., brain tumor, vascular malformation, abscess).
• Patients with recurrent CSDH or with previous craniotomy or other transcranial surgery (for any reason)
• Patients unable to give consent prior to surgery

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
24 hours active subperiostal drainage	24 hours active subperiostal drainage	24 hours active subperiostal drainage after single burr hole evacuation of a chronic subdural hematoma
24 hours passive subdural drainage	24 hours passive subdural drainage	24 hours passive subdural drainage after single burr hole evacuation of a chronic subdural hematoma

Primary Outcome Measures

Name	Time	Method
Composite outcome of 90-day mortality and recurrent CSDH on the same side as the primary operation requiring reoperation within the 90-day observation period	From enrollment to 90-days postsurgery	The primary outcome measure 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 observation period. Recurrent CSDH is defined as a re-accumulation of the previously treated CSDH requiring ipsilateral or bilateral reoperation following symptom improvement after the first operation. For both unilateral and bilateral hematomas, recurrence will be considered as one reoperation.

Secondary Outcome Measures

Name	Time	Method
90-day modified Rankin scale	90 days after enrollment	The scores on the modified Rankin scale will be assessed with the use of the simplified mRS validated questionnaire, which will be completed over the telephone by the patients or next of kin at 3 months after surgery. The results will be dichotomized and analyzed with 0-2 as favourable clinical outcome and 3-6 as unfavourable outcome.
Complications related to surgery	From enrollment to 90-days postsurgery	Complications related to surgery encompasing intracerebral hemorrhage due to misplaced drains, acute subdural hematoma, tension pneumocephalus, wound infection, drain seepage, subperiostal hematoma, and seizures.
90-day mortality and registered cause of death.	From enrollment to 90-days postsurgery	Mortality within 90 days of the performed surgery; Registred cause of death
Discharge destination	From enrollment to 90-days postsurgery	Discharge destination after completed neurosurgical CSDH evacuation encompassing home, nursing home, other hospital department
Postoperative adverse events during the admission	From enrollment to admission from hospital assessed up to 90-days postsurgery	Postoperative adverse events during the admission emcompassing thromboembolic events and/or infections.
Length of hospitalization	From enrollment to admission from neurosurgical department, and from surgical CSDH evacuation to discarge to home or nursing facility, assessed up to 90-days postsurgery	Length (days) of admission to neurosurgical department. Length (days) of hospitalization in total after surgical CSDH evacuation

Trial Locations

Locations (4)

Department of Neurosurgery, Aalborg University Hospital; 🇩🇰 Aalborg, Denmark

Department of Neurosurgery, Aarhus University Hospital; 🇩🇰 Aarhus, Denmark

Department of Neurosurgery, Copenhagen University Hospital Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Department of Neurosurgery, Odense University Hospital; 🇩🇰 Odense, Denmark