Volume reduction with surgery for ICH: when is it effective? Analysis of the CT scans from the STICH II trial.

Background: The surgical trial of lobar intracerebral haemorrhage (STICH II) was a randomised controlled trial evaluating early surgical removal of a clot. This paper investigates volume change in both arms of the trial with respect to Extended Glasgow Outcome Scale (GOSE) groups.

Methods: Patients randomised into STICH II had an initial diagnostic CT and a second CT 5 days after randomisation.

Evaluation of Outcomes Among Patients With Traumatic Intracranial Hypertension Treated With Decompressive Craniectomy vs Standard Medical Care at 24 Months: A Secondary Analysis of the RESCUEicp Randomized Clinical Trial.

Importance: Trials often assess primary outcomes of traumatic brain injury at 6 months. Longer-term data are needed to assess outcomes for patients receiving surgical vs medical treatment for traumatic intracranial hypertension.

Objective: To evaluate 24-month outcomes for patients with traumatic intracranial hypertension treated with decompressive craniectomy or standard medical care.

Intracerebral Hemorrhage Volume Reduction and Timing of Intervention Versus Functional Benefit and Survival in the MISTIE III and STICH Trials.

Background: The extent of intracerebral hemorrhage (ICH) removal conferred survival and functional benefits in the minimally invasive surgery with thrombolysis in intracerebral hemorrhage evacuation (MISTIE) III trial. It is unclear whether this similarly impacts outcome with craniotomy (open surgery) or whether timing from ictus to intervention influences outcome with either procedure.

Objective: To compare volume evacuation and timing of surgery in relation to outcomes in the MISTIE III and STICH (Surgical Trial in Intracerebral Hemorrhage) trials.

Thrombolysis for Evacuation of Intracerebral and Intraventricular Hemorrhage: A Guide to Surgical Protocols With Practical Lessons Learned From the MISTIE and CLEAR Trials.

Background: Minimally Invasive Surgery Plus Recombinant Tissue Plasminogen Activator for Intracerebral Hemorrhage Evacuation (MISTIE) procedure was recently tested in a large phase III randomized trial showing a significant probability of functional benefit in those cases that reached the goal hematoma evacuation of ≤15 mL residual (or ≥70% removal). Benefit of thrombolysis was also identified in cases with large intraventricular hemorrhage, and achieving at least 85% volume reduction in the Evaluating Accelerated Resolution of Intraventricular Hemorrhage (CLEAR) III trial.

Objective: To protocolize steps in the MISTIE and CLEAR procedures in order to maximize hematoma evacuation and minimize complications.

A randomized 500-subject open-label phase 3 clinical trial of minimally invasive surgery plus alteplase in intracerebral hemorrhage evacuation (MISTIE III).

Rationale And Hypothesis: Surgical removal of spontaneous intracerebral hemorrhage may reduce secondary destruction of brain tissue. However, large surgical trials of craniotomy have not demonstrated definitive improvement in clinical outcomes. Minimally invasive surgery may limit surgical tissue injury, and recent evidence supports testing these approaches in large clinical trials.

Surgical Decision Making in Brain Hemorrhage.

Background and Purpose- The STICH (Surgical Trial in Lobar Intracerebral Haemorrhage) I and II trials randomized patients with spontaneous intracerebral hemorrhage (ICH) to early surgery or initial conservative treatment. Both were nonsignificant; possibly because surgery has minimal effect on recovery, or because surgery benefits some and harms others. We introduce a new nonparametric method of analysis.

Efficacy and safety of minimally invasive surgery with thrombolysis in intracerebral haemorrhage evacuation (MISTIE III): a randomised, controlled, open-label, blinded endpoint phase 3 trial.

Background: Acute stroke due to supratentorial intracerebral haemorrhage is associated with high morbidity and mortality. Open craniotomy haematoma evacuation has not been found to have any benefit in large randomised trials. We assessed whether minimally invasive catheter evacuation followed by thrombolysis (MISTIE), with the aim of decreasing clot size to 15 mL or less, would improve functional outcome in patients with intracerebral haemorrhage.

Thrombolytic removal of intraventricular haemorrhage in treatment of severe stroke: results of the randomised, multicentre, multiregion, placebo-controlled CLEAR III trial.

Background: Intraventricular haemorrhage is a subtype of intracerebral haemorrhage, with 50% mortality and serious disability for survivors. We aimed to test whether attempting to remove intraventricular haemorrhage with alteplase versus saline irrigation improved functional outcome.

Methods: In this randomised, double-blinded, placebo-controlled, multiregional trial (CLEAR III), participants with a routinely placed extraventricular drain, in the intensive care unit with stable, non-traumatic intracerebral haemorrhage volume less than 30 mL, intraventricular haemorrhage obstructing the 3rd or 4th ventricles, and no underlying pathology were adaptively randomly assigned (1:1), via a web-based system to receive up to 12 doses, 8 h apart of 1 mg of alteplase or 0·9% saline via the extraventricular drain.

Safety and efficacy of minimally invasive surgery plus alteplase in intracerebral haemorrhage evacuation (MISTIE): a randomised, controlled, open-label, phase 2 trial.

Background: Craniotomy, according to the results from trials, does not improve functional outcome after intracerebral haemorrhage. Whether minimally invasive catheter evacuation followed by thrombolysis for clot removal is safe and can achieve a good functional outcome is not known. We investigated the safety and efficacy of alteplase, a recombinant tissue plasminogen activator, in combination with minimally invasive surgery (MIS) in patients with intracerebral haemorrhage.

Trial of Decompressive Craniectomy for Traumatic Intracranial Hypertension.

Background: The effect of decompressive craniectomy on clinical outcomes in patients with refractory traumatic intracranial hypertension remains unclear.

Methods: From 2004 through 2014, we randomly assigned 408 patients, 10 to 65 years of age, with traumatic brain injury and refractory elevated intracranial pressure (>25 mm Hg) to undergo decompressive craniectomy or receive ongoing medical care. The primary outcome was the rating on the Extended Glasgow Outcome Scale (GOS-E) (an 8-point scale, ranging from death to "upper good recovery" [no injury-related problems]) at 6 months.

Attitudes in 2013 to Monitoring Intracranial Pressure for Traumatic Intracerebral Haemorrhage.

Introduction: Recent research has been equivocal regarding the usefulness of intracranial pressure (ICP) monitoring for traumatic intracerebral haemorrhage (ICH). We aimed to investigate attitudes of clinicians from as wide an international audience as possible.

Materials And Methods: A SurveyMonkey® questionnaire was distributed to individuals, including members of the Society of British Neurological Surgeons, the European Brain Injury Consortium, the Euroacademia Multidisciplinaria Neurotraumatologica and the neurotrauma committee of the World Federation of Neurosurgical Societies.

Surgical Craniotomy for Intracerebral Haemorrhage.

Craniotomy is probably indicated for patients with superficial spontaneous lobar supratentorial intracerebral haemorrhage (ICH) when the level of consciousness drops below 13 within the first 8 h of the onset of the haemorrhage. Once the level drops below 9, it is probably too late to consider craniotomy for these patients, so clinical vigilance is paramount. While this statement is only backed up by evidence that is moderately strong, meta-analysis of available data suggests that it is true in the rather limited number of patients with ICH.

Surgical Trial In Traumatic intraCerebral Haemorrhage (STITCH): a randomised controlled trial of Early Surgery compared with Initial Conservative Treatment.

Background: While it is accepted practice to remove extradural (EDH) and subdural haematomas (SDH) following traumatic brain injury, the role of surgery in parenchymal traumatic intracerebral haemorrhage (TICH) is controversial. There is no evidence to support Early Surgery in this condition.

Objectives: There have been a number of trials investigating surgery for spontaneous intracerebral haemorrhage but none for TICH.

Early Surgery versus Initial Conservative Treatment in Patients with Traumatic Intracerebral Hemorrhage (STITCH[Trauma]): The First Randomized Trial.

Intraparenchymal hemorrhages occur in a proportion of severe traumatic brain injury TBI patients, but the role of surgery in their treatment is unclear. This international multi-center, patient-randomized, parallel-group trial compared early surgery (hematoma evacuation within 12 h of randomization) with initial conservative treatment (subsequent evacuation allowed if deemed necessary). Patients were randomized using an independent randomization service within 48 h of TBI.

A histogram-based similarity measure for quantitative magnetic resonance imaging: application in acute mild traumatic brain injury.

Objectives: The most commonly used summary metric in neuroimaging is the mean value, but this pays little attention to the shape of the data distribution and can therefore be insensitive to subtle changes that alter the data distribution.

Methods: We propose a distributional-based metric called the normalized histogram similarity measure (HSM) for characterization of quantitative images. We applied HSM to quantitative magnetic resonance imaging T1 relaxation data of 44 patients with mild traumatic brain injury and compared with data of 43 age-matched controls.

European Stroke Organisation (ESO) guidelines for the management of spontaneous intracerebral hemorrhage.

Background: Intracerebral hemorrhage (ICH) accounted for 9% to 27% of all strokes worldwide in the last decade, with high early case fatality and poor functional outcome. In view of recent randomized controlled trials (RCTs) of the management of ICH, the European Stroke Organisation (ESO) has updated its evidence-based guidelines for the management of ICH.

Method: A multidisciplinary writing committee of 24 researchers from 11 European countries identified 20 questions relating to ICH management and created recommendations based on the evidence in RCTs using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.

White matter correlates of cognitive dysfunction after mild traumatic brain injury.

Objective: To relate neurophysiologic changes after mild/moderate traumatic brain injury to cognitive deficit in a longitudinal diffusion tensor imaging investigation.

Methods: Fifty-three patients were scanned an average of 6 days postinjury (range = 1-14 days). Twenty-three patients were rescanned 1 year later.

Attitudes to intracranial pressure monitoring of traumatic intracerebral haemorrhage.

Introduction: Recent research has been equivocal regarding the usefulness of intracranial pressure (ICP) monitoring for traumatic intracerebral haemorrhage (ICH). We aimed to investigate attitudes of clinicians from as wide an international audience as possible.

Materials And Methods: A SurveyMonkey(®) questionnaire was distributed to individuals, including members of the Society of British Neurological Surgeons, the European Brain Injury Consortium, the neurotrauma committee of the Euroacademia Multidisciplinaria Neurotraumatologica and the World Federation of Neurosurgical Societies.

What does it take to deliver an international neurosurgical trial? Experiences from STICH II.

Background And Purpose: When undertaking multicentre randomised controlled trials some obstacles cause a slower than required recruitment rate. This article discusses factors that affected the completion of the international neurosurgical trial STICH II, which took almost 6 years.

Methods: We reviewed the following factors: recruitment of participating sites, patient recruitment, patient screening, trial fatigue and maintenance of profile and maintenance of quality and standards.

A multicenter, randomized, double-blinded, placebo-controlled phase III study of Clot Lysis Evaluation of Accelerated Resolution of Intraventricular Hemorrhage (CLEAR III).

Background: In adults, intraventricular thrombolytic therapy with recombinant tissue plasminogen activator (rtPA) facilitates resolution of intraventricular haemorrhage (IVH), reduces intracranial pressure, decreases duration of cerebrospinal fluid diversion, and may ameliorate direct neural injury. We hypothesize that patients with small parenchymal haematoma volumes (<30 cc) and relatively large IVH causing acute obstructive hydrocephalus would have improved clinical outcomes when given injections of low-dose rtPA to accelerate lysis and evacuation of IVH compared with placebo.

Methods: The Clot Lysis Evaluation of Accelerated Resolution of Intraventricular Hemorrhage III trial is an investigator-initiated, phase III, randomized, multicenter, double-blind, placebo-controlled study comparing the use of external ventricular drainage (EVD) combined with intraventricular injection of rtPA to EVD plus intraventricular injection of normal saline (placebo) for the treatment of IVH.