Enlighten-Research publications by members of the University of Glasgow http://eprints.gla.ac.uk Minimally invasive surgery with thrombolysis in intracerebral haemorrhage evacuation (MISTIE III): a randomised, controlled, open-label phase 3 trial with blinded endpoint

BACKGROUND:Minimally invasive surgery procedures, including stereotactic catheter aspiration and clearance of intracerebral hemorrhage (ICH) with recombinant tissue plasminogen activator hold a promise to improve outcome of supratentorial brain hemorrhage, a morbid and disabling type of stroke. A recently completed Phase III randomized trial showed improved mortality but was neutral on the primary outcome (modified Rankin scale score 0 to 3 at 1 yr). OBJECTIVE: To assess surgical performance and its impact on the extent of ICH evacuation and functional outcomes. METHODS: Univariate and multivariate models were used to assess the extent of hematoma evacuation efficacy in relation to mRS 0 to 3 outcome and postulated factors related to patient, disease, and protocol adherence in the surgical arm (n = 242) of the MISTIE trial. RESULTS: Greater ICH reduction has a higher likelihood of achieving mRS of 0 to 3 with a minimum evacuation threshold of ≤15 mL end of treatment ICH volume or ≥70% volume reduction when controlling for disease severity factors. Mortality benefit was achieved at ≤30 mL end of treatment ICH volume, or >53% volume reduction. Initial hematoma volume, history of hypertension, irregular-shaped hematoma, number of alteplase doses given, surgical protocol deviations, and catheter manipulation problems were significant factors in failing to achieve ≤15 mL goal evacuation. Greater surgeon/site experiences were associated with avoiding poor hematoma evacuation. CONCLUSION: This is the first surgical trial reporting thresholds for reduction of ICH volume correlating with improved mortality and functional outcomes. To realize the benefit of surgery, protocol objectives, surgeon education, technical enhancements, and case selection should be focused on this goal.

The primary goal of this study was to determine the incidence of post-traumatic ventriculomegaly (Evans' index > or = 0.30) in 95 head-injured patients with a Glasgow Coma Scale (GCS) score of < or =13 at admission. Additional objectives were to determine the relationship between an increase in ventricular size and several clinical and radiological features and outcome. A planimetric study was carried out in the sequential control computed tomography (CT) scans of 34 moderately head-injured (GCS 9-13) and 61 severely head-injured (GCS 3-8) patients with a minimum follow-up of 2 months. Between two and six CT scans were evaluated in each patient. The presence of subarachnoid hemorrhage (SAH) was registered. Evans' index was determined in all CT scans. In the final CT scan of each patient, ventricular size was related to the admission GCS score, age, the presence of SAH in the initial CT scans, type of brain lesion (classified according to the final diagnosis in the Traumatic Coma Data Bank classification), and outcome. Ventriculomegaly was found in 39.3% of patients with severe head injury and in 27.3% of those with a moderate head injury. Increased ventricular size was evident 4 weeks after injury in 57.6% and 2 months after injury in 69.7%. No relationship was found between post-traumatic ventriculomegaly and age, initial GCS score, the presence of SAH, or type of lesion (focal or diffuse). Post-traumatic ventriculomegaly was significantly correlated with outcome. Post-traumatic ventriculomegaly is a frequent and early finding in patients with moderate or severe traumatic brain injury.

To assess the safety and accuracy of the Camino intraparenchymal sensor, we prospectively evaluated hemorrhagic complications, zero-drift, infection, and system malfunction in 163 patients monitored after a severe head injury. Mean duration of intracranial pressure (ICP) monitoring was 5 +/- 2.2 days (range: 12 h to 11 days). Of the 141 patients with a control CT scan, four showed a 1-2-cc collection of blood at the catheter's end. When removed, the sensors underread the true ICP value (negative zero-drift) in 80 of the 126 sensors evaluated (63.5%). Fourteen sensors showed no zero-drift, and 32 sensors overread the true ICP value (positive zero-drift) (median: -1 mm Hg; interquartile range: -4 to +1 mm Hg). No significant relationship was found between zero-drift, the surgeon who implanted the sensor, intracranial hypertension, or duration of ICP monitoring. No clinical infections could be attributed to the devices. Sixteen patients (9.8%) required more than one ICP sensor due to malfunctioning of the system. In conclusion, continuous ICP monitoring using the Camino intraparenchymal sensor has a low complication rate. However, this sensor may underread the real ICP values in a high number of patients. The lack of correlation between duration of ICP monitoring and zero-drift suggests that, contrary to the recommendations of other reports, the intraparenchymatous Camino sensor can provide reliable readings after the fifth day of use.

Non-invasive estimation of intracranial pressure by diffuse optics -a proof-of-concept study Running title (40/45 characters): Non-invasive estimation of ICP by optics Table of contents title (75/75 characters): Non-invasive estimation of ICP by diffuse optics -a proof-of-concept study