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In an international trial involving 450 patients with acute subdural hematoma, craniotomy (bone flap replaced) and decompressive craniectomy (bone flap left out) yielded similar disability-related outcomes at 12 months.

It is unknown whether decompressive craniectomy improves clinical outcome for people with spontaneous severe deep intracerebral haemorrhage. The SWITCH trial aimed to assess whether decompressive craniectomy plus best medical treatment in these patients improves outcome at 6 months compared to best medical treatment alone. In this multicentre, randomised, open-label, assessor-blinded trial conducted in 42 stroke centres in Austria, Belgium, Finland, France, Germany, the Netherlands, Spain, Sweden, and Switzerland, adults (18–75 years) with a severe intracerebral haemorrhage involving the basal ganglia or thalamus were randomly assigned to receive either decompressive craniectomy plus best medical treatment or best medical treatment alone. The primary outcome was a score of 5–6 on the modified Rankin Scale (mRS) at 180 days, analysed in the intention-to-treat population. This trial is registered with ClincalTrials.gov, NCT02258919, and is completed. SWITCH had to be stopped early due to lack of funding. Between Oct 6, 2014, and April 4, 2023, 201 individuals were randomly assigned and 197 gave delayed informed consent (96 decompressive craniectomy plus best medical treatment, 101 best medical treatment). 63 (32%) were women and 134 (68%) men, the median age was 61 years (IQR 51–68), and the median haematoma volume 57 mL (IQR 44–74). 42 (44%) of 95 participants assigned to decompressive craniectomy plus best medical treatment and 55 (58%) assigned to best medical treatment alone had an mRS of 5–6 at 180 days (adjusted risk ratio [aRR] 0·77, 95% CI 0·59 to 1·01, adjusted risk difference [aRD] −13%, 95% CI −26 to 0, p=0·057). In the per-protocol analysis, 36 (47%) of 77 participants in the decompressive craniectomy plus best medical treatment group and 44 (60%) of 73 in the best medical treatment alone group had an mRS of 5–6 (aRR 0·76, 95% CI 0·58 to 1·00, aRD −15%, 95% CI −28 to 0). Severe adverse events occurred in 42 (41%) of 103 participants receiving decompressive craniectomy plus best medical treatment and 41 (44%) of 94 receiving best medical treatment. SWITCH provides weak evidence that decompressive craniectomy plus best medical treatment might be superior to best medical treatment alone in people with severe deep intracerebral haemorrhage. The results do not apply to intracerebral haemorrhage in other locations, and survival is associated with severe disability in both groups. Swiss National Science Foundation, Swiss Heart Foundation, Inselspital Stiftung, and Boehringer Ingelheim.

Degenerative cervical myelopathy represents the most common form of non-traumatic spinal cord injury. This trial investigated whether riluzole enhances outcomes in patients undergoing decompression surgery for degenerative cervical myelopathy. This multicentre, double-blind, placebo-controlled, randomised, phase 3 trial was done at 16 university-affiliated centres in Canada and the USA. Patients with moderate-to-severe degenerative cervical myelopathy aged 18–80 years, who had a modified Japanese Orthopaedic Association (mJOA) score of 8–14, were eligible. Patients were randomly assigned (1:1) to receive either oral riluzole (50 mg twice a day for 14 days before surgery and then for 28 days after surgery) or placebo. Randomisation was done using permuted blocks stratified by study site. Patients, physicians, and outcome assessors remained masked to treatment group allocation. The primary endpoint was change in mJOA score from baseline to 6 months in the intention-to-treat (ITT) population, defined as all individuals who underwent randomisation and surgical decompression. Adverse events were analysed in the modified intention-to-treat (mITT) population, defined as all patients who underwent randomisation, including those who did not ultimately undergo surgical decompression. This study is registered with ClinicalTrials.gov, NCT01257828. From Jan 31, 2012, to May 16, 2017, 408 patients were screened. Of those screened, 300 were eligible (mITT population); 290 patients underwent decompression surgery (ITT population) and received either riluzole (n=141) or placebo (n=149). There was no difference between the riluzole and placebo groups in the primary endpoint of change in mJOA score at 6-month follow-up: 2·45 points (95% CI 2·08 to 2·82 points) versus 2·83 points (2·47 to 3·19), difference −0·38 points (−0·90 to 0·13; p=0·14). The most common adverse events were neck or arm or shoulder pain, arm paraesthesia, dysphagia, and worsening of myelopathy. There were 43 serious adverse events in 33 (22%) of 147 patients in the riluzole group and 34 serious adverse events in 29 (19%) of 153 patients in the placebo group. The most frequent severe adverse events were osteoarthrosis of non-spinal joints, worsening of myelopathy, and wound complications. In this trial, adjuvant treatment for 6 weeks perioperatively with riluzole did not improve functional recovery beyond decompressive surgery in patients with moderate-to-severe degenerative cervical myelopathy. Whether riluzole has other benefits in this patient population merits further study. AOSpine North America.

Cranioplasty (CP), a surgical procedure that restores cranial integrity and potentially enhances neurological outcomes, is commonly performed following decompressive craniectomy for various reasons. However, there is considerable controversy and variation regarding the optimal timing for cranioplasty, particularly concerning its impact on neurological functional outcomes. This paper outlines the protocol for a multicenter, non-randomized controlled trial designed to investigate whether the timing of cranioplasty influences neurological outcomes. This study will be conducted from June 2025 to June 2026 across multiple clinical centers in China, targeting the enrollment of at least 500 adults aged 18-65 years with skull defects larger than 25 cm². Participants will be divided based on the timing of their cranioplasty relative to decompressive craniectomy into two groups: early (within 3 months post-decompression) and late (after 3 months). The primary outcome, assessed through the Barthel Index, will measure functional recovery 6 months post-surgery, with secondary outcomes including mortality, quality of life, cognitive performance and complication rates. This non-randomized clinical trial focuses on the neurological outcomes associated with different timings of cranioplasty. It is anticipated that the findings will contribute valuable insights and support more informed clinical decisions regarding the timing of cranioplasty. By comparing early and late cranioplasty, the trial aims to clarify how timing affects recovery and overall neurological improvement post-surgery. Trial Registration: ChiCTR2400094619.

Wig protectors produced via 3D printing were used in skull protection protocols following decompressive craniotomy (DC) surgery. This study is a single-center, prospective trial involving 25 patients who underwent DC. Patients admitted between February 1, 2023, and June 30, 2023, were assigned to the control group (receiving standard care), while those admitted between July 1, 2023, and December 31, 2023, comprised the experimental group (receiving 3D-printed wig protection). The study evaluated participants based on various metrics, including reinjury at the site of the skull defect, daily wear duration, skin indentation, pain levels, itching, discomfort, patient-reported aesthetics, and the Quality of Life (QLQ-C30). They completed both wear assessments and follow-up evaluations at 1, 4, 8, and 12 weeks. Post-intervention, the experimental group exhibited a lower incidence of secondary injuries compared to the control group (0 vs. 3, P  = 0.206). At the three-month follow-up, the experimental group demonstrated better outcomes in self-assessed aesthetics ( P  = 0.025) and QLQ-C30 scores ( P  = 0.041). The 3D-printed wig protector had a weight of 132.3 ± 11.98 g (ranging from 111 to 146 g), and none of the patients in the experimental group reported pain, pressure, itching, or discomfort during the first 30-min wear period. On average, patients wore the device for 2.01 ± 0.22 h in week 1, 5.71 ± 0.40 h in week 4, 6.04 ± 0.10 h in week 8, and 5.93 ± 0.47 h in week 12. While some patients reported minor skin indentation, pain, itching, or a sensation of stuffiness, no serious adverse events were observed.

ObjectiveTo evaluate the value of an adjuvant cisternostomy (AC) to decompressive craniectomy (DC) for the management of patients with severe traumatic brain injury (sTBI).MethodsA single-center retrospective quality control analysis of a consecutive series of sTBI patients surgically treated with AC or DC alone between 2013 and 2018. A subgroup analysis, “primary procedure” and “secondary procedure”, was also performed. We examined the impact of AC vs. DC on clinical outcome, including long-term (6 months) extended Glasgow outcome scale (GOS-E), the duration of postoperative ventilation, and intensive care unit (ICU) stay, mortality, Glasgow coma scale at discharge, and time to cranioplasty. We also evaluated and analyzed the impact of AC vs. DC on post-procedural intracranial pressure (ICP) and brain tissue oxygen (PbO2) values as well as the need for additional osmotherapy and CSF drainage.ResultsForty patients were examined, 22 patients in the DC group, and 18 in the AC group. Compared with DC alone, AC was associated with significant shorter duration of mechanical ventilation and ICU stay, as well as better Glasgow coma scale at discharge. Mortality rate was similar. At 6-month, the proportion of patients with favorable outcome (GOS-E ≥ 5) was higher in patients with AC vs. DC [10/18 patients (61%) vs. 7/20 (35%)]. The outcome difference was particularly relevant when AC was performed as primary procedure (61.5% vs. 18.2%; p = 0.04). Patients in the AC group also had significant lower average post-surgical ICP values, higher PbO2 values and required less osmotic treatments as compared with those treated with DC alone.ConclusionOur preliminary single-center retrospective data indicate that AC may be beneficial for the management of severe TBI and is associated with better clinical outcome. These promising results need further confirmation by larger multicenter clinical studies. The potential benefits of cisternostomy should not encourage its universal implementation across trauma care centers by surgeons that do not have the expertise and instrumentation necessary for cisternal microsurgery. Training in skull base and vascular surgery techniques for trauma care surgeons would avoid the potential complications associated with this delicate procedure.

Background Poor-grade aneurysmal subarachnoid hemorrhage (SAH) is associated with poor neurological outcome and high mortality. A major factor influencing morbidity and mortality is brain swelling in the acute phase. Decompressive craniectomy (DC) is currently used as an option in order to reduce intractably elevated intracranial pressure (ICP). However, execution and optimal timing of DC remain unclear. Methods PICASSO resembles a multicentric, prospective, 1:1 randomized standard treatment-controlled trial which analyzes whether primary DC (pDC) performed within 24 h combined with the best medical treatment in patients with poor-grade SAH reduces mortality and severe disability in comparison to best medical treatment alone and secondary craniectomy as ultima ratio therapy for elevated ICP. Consecutive patients presenting with poor-grade SAH, defined as grade 4–5 according to the World Federation of Neurosurgical Societies (WFNS), will be screened for eligibility. Two hundred sixteen patients will be randomized to receive either pDC additional to best medical treatment or best medical treatment alone. The primary outcome is the clinical outcome according to the modified Rankin Scale (mRS) at 12 months, which is dichotomized to favorable (mRS 0–4) and unfavorable (mRS 5–6). Secondary outcomes include morbidity and mortality, time to death, length of intensive care unit (ICU) stay and hospital stay, quality of life, rate of secondary DC due to intractably elevated ICP, effect of size of DC on outcome, use of duraplasty, and complications of DC. Discussion This multicenter trial aims to generate the first confirmatory data in a controlled randomized fashion that pDC improves the outcome in a clinically relevant endpoint in poor-grade SAH patients. Trial registration DRKS DRKS00017650. Registered on 09 June 2019.

Background Traumatic brain injury (TBI) and stroke have devastating consequences and are major global public health issues. For patients that require a cerebral decompression after suffering a TBI or stroke, a decompressive craniectomy (DC) is the most commonly performed operation. However, retrospective non-randomized studies suggest that a decompressive craniotomy (DCO; also known as hinge or floating craniotomy), where a bone flap is replaced but not rigidly fixed, has comparable outcomes to DC. The primary aim of this project was to understand the current extent of usage of DC and DCO for TBI and stroke worldwide. Method A questionnaire was designed and disseminated globally via emailing lists and social media to practicing neurosurgeons between June and November 2019. Results We received 208 responses from 60 countries [40 low- and middle-income countries (LMICs)]. DC is used more frequently than DCO, however, about one-quarter of respondents are using a DCO in more than 25% of their patients. The three top indications for a DCO were an acute subdural hematoma (ASDH) and a GCS of 9-12, ASDH with contusions and a GCS of 3-8, and ASDH with contusions and a GCS of 9-12. There were 8 DCO techniques used with the majority (60/125) loosely tying sutures to the bone flap. The majority (82%) stated that they were interested in collaborating on a randomized trial of DCO vs. DC. Conclusion Our results show that DCO is a procedure carried out for TBI and stroke, especially in LMICs, and most commonly for an ASDH. The majority of the respondents were interested in collaborating on a is a future randomized trial.

Background: Evidence suggests that liberal transfusion and anemia correction have negative effects on patients with acute brain injuries (ABI). Such patients with indications for decompressive surgeries require precise and real-time monitoring technology for estimation of intraoperative hemoglobin in order to assess the need for transfusion. Aims: The primary objective was to evaluate non-invasive hemoglobin (SpHb) monitoring as a guide for red blood cell transfusion (RBCT) during emergency decompressive craniotomy in ABI patients. The secondary objectives were to evaluate the incidence of postoperative infections, length of ICU stay, duration of mechanical ventilation, 30-day mortality, and extended Glasgow outcome scale (E-GOS) score at 90 days. Methods and Material: Eighty patients (aged 18-65) with ABI requiring decompressive surgery were randomized into two groups of 40 patients each: group A (SpHb monitoring group) and group B (standard care group). They were compared for RBCT management, and postoperative infections, ventilator days, length of stay in ICU, E-GOS, and mortality. RESULTS: The number of patients requiring a single RBCT was significantly higher in group A as compared to Group B (P < 0.0001). However, patients requiring two transfusions and the total volume of RBCT were higher in group B (P < 0.01). Three or more RBCT were required only in Group B (P 0.07). The duration of mechanical ventilation was higher in group B as opposed to group A (P 0.07). However, there was no significant difference in the hemodynamic variables between the two groups. Conclusions: The inclusion of continuous SpHb monitoring during decompressive procedures in ABI patients may assist in the optimal management of blood transfusion, thereby reducing transfusion-related complications.

Rationale: Decompressive craniectomy (DC) is beneficial in people with malignant middle cerebral artery infarction. Whether DC improves outcome in spontaneous intracerebral haemorrhage (ICH) is unknown. Aim: To determine whether DC without haematoma evacuation plus best medical treatment (BMT) in people with ICH decreases the risk of death or dependence at 6 months compared to BMT alone. Methods and design: SWITCH is an international, multicentre, randomised (1:1), two-arm, open-label, assessor-blinded trial. Key inclusion criteria are age ⩽75 years, stroke due to basal ganglia or thalamic ICH that may extend into cerebral lobes, ventricles or subarachnoid space, Glasgow coma scale of 8–13, NIHSS score of 10–30 and ICH volume of 30–100 mL. Randomisation must be performed <66 h after onset and DC <6 h after randomisation. Both groups will receive BMT. Participants randomised to the treatment group will receive DC of at least 12 cm in diameter according to institutional standards. Sample size: A sample of 300 participants randomised 1:1 to DC plus BMT versus BMT alone provides over 85% power at a two-sided alpha-level of 0.05 to detect a relative risk reduction of 33% using a chi-squared test. Outcomes: The primary outcome is the composite of death or dependence, defined as modified Rankin scale score 5–6 at 6 months. Secondary outcomes include death, functional status, quality of life and complications at 180 days and 12 months. Discussion: SWITCH will inform physicians about the outcomes of DC plus BMT in people with spontaneous deep ICH, compared to BMT alone. Trial registration: ClinicalTrials.gov Identifier: NCT02258919 Graphical abstract