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. This study aimed to establish whether or not a policy of Early Surgery for TICH improves outcome compared with a policy of Initial Conservative Treatment. DESIGN: This was an international multicentre pragmatic parallel group trial. Patients were randomised via an independent telephone/web-based randomisation service. SETTING: Neurosurgical units in 59 hospitals in 20 countries registered to take part in the study. PARTICIPANTS: The study planned to recruit 840 adult patients. Patients had to be within 48 hours of head injury with no more than two intracerebral haematomas greater than 10 ml. They did not have a SDH or EDH that required evacuation or any severe comorbidity that would mean they could not achieve a favourable outcome if they made a complete recovery from their head injury. INTERVENTIONS: Patients were randomised to Early Surgery within 12 hours or to Initial Conservative Treatment with delayed evacuation if it became clinically appropriate. MAIN OUTCOME MEASURES: The Extended Glasgow Outcome Scale (GOSE) was measured at 6 months via a postal questionnaire. The primary outcome was the traditional dichotomised split into favourable outcome (good recovery or moderate disability) and unfavourable outcome (severe disability, vegetative, dead). Secondary outcomes included mortality and an ordinal assessment of Glasgow Outcome Scale and Rankin Scale. RESULTS: Patient recruitment began in December 2009 but was halted by the funding body because of low UK recruitment in September 2012. In total, 170 patients were randomised from 31 centres in 13 countries: 83 to Early Surgery and 87 to Initial Conservative Treatment. Six-month outcomes were obtained for 99% of 168 eligible patients (82 Early Surgery and 85 Initial Conservative Treatment patients). Patients in the Early Surgery group were 10.5% more likely to have a favourable outcome (absolute benefit), but this difference did not quite reach statistical significance because of the reduced sample size. Fifty-two (63%) had a favourable outcome with Early Surgery, compared with 45 (53%) with Initial Conservative Treatment [odds ratio 0.65; 95% confidence interval (CI) 0.35 to 1.21; p = 0.17]. Mortality was significantly higher in the Initial Conservative Treatment group (33% vs. 15%; absolute difference 18.3%; 95% CI 5.7% to 30.9%; p = 0.006). The Rankin Scale and GOSE were significantly improved with Early Surgery using a trend analysis (p = 0.047 and p = 0.043 respectively). CONCLUSIONS: This is the first ever trial of surgery for TICH and indicates that Early Surgery may be a valuable tool in the treatment of TICH, especially if the Glasgow Coma Score is between 9 and 12, as was also found in Surgical Trial In spontaneous intraCerebral Haemorrhage (STICH) and Surgical Trial In spontaneous lobar intraCerebral Haemorrhage (STICH II). Further research is clearly warranted. TRIAL REGISTRATION: Current Controlled Trials ISRCTN 19321911. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 19, No. 70. See the NIHR Journals Library website for further project information.

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. Patients were eligible if they had no more than two intraparenchymal hemorrhages of 10 mL or more and did not have an extradural or subdural hematoma that required surgery. The primary outcome measure was the traditional dichotomous split of the Glasgow Outcome Scale obtained by postal questionnaires sent directly to patients at 6 months. The trial was halted early by the UK funding agency (NIHR HTA) for failure to recruit sufficient patients from the UK (trial registration: ISRCTN19321911). A total of 170 patients were randomized from 31 of 59 registered centers worldwide. Of 82 patients randomized to early surgery with complete follow-up, 30 (37%) had an unfavorable outcome. Of 85 patients randomized to initial conservative treatment with complete follow-up, 40 (47%) had an unfavorable outcome (odds ratio, 0.65; 95% confidence interval, CI 0.35, 1.21; p=0.17), with an absolute benefit of 10.5% (CI, -4.4-25.3%). There were significantly more deaths in the first 6 months in the initial conservative treatment group (33% vs. 15%; p=0.006). The 10.5% absolute benefit with early surgery was consistent with the initial power calculation. However, with the low sample size resulting from the premature termination, we cannot exclude the possibility that this could be a chance finding. A further trial is required urgently to assess whether this encouraging signal can be confirmed.

A multi-parameter system for use in neonatal resuscitation research and training.

Training staff in the resuscitation of neonates is an essential skill; resuscitation efficacy is difficult to quantify but critical to infant survival. Objective assessments of the efficacy of training methods, resuscitation techniques and devices have used concurrent measurements of air flow and air pressure in commercially available manikins. This system also simultaneously measures the force transmitted through the manikin head during simulated resuscitation, as applying excessive force may be deleterious to newborn infants. The overall accuracy of the force plate over the range 0-5 kg was 0.5%; the output was linear; the frequency response sufficiently high and there was no evidence of hysteresis. This system enables comparison of staff groups, resuscitation techniques and devices in an accurate and reproducible manner. Its use could improve training by offering a means of objective performance feedback through a range of parameters. Evaluation of clinical practice may also result in direct patient benefit.

Surgical trial in traumatic intracerebral hemorrhage (STITCH(Trauma)): study protocol for a randomized controlled trial.

BACKGROUND: Intracranial hemorrhage occurs in over 60% of severe head injuries in one of three types: extradural (EDH); subdural (SDH); and intraparenchymal (TICH). Prompt surgical removal of significant SDH and EDH is established and widely accepted. However, TICH is more common and is found in more than 40% of severe head injuries. It is associated with a worse outcome but the role for surgical removal remains undefined. Surgical practice in the treatment of TICHs differs widely around the world. The aim of early surgery in TICH removal is to prevent secondary brain injury. There have been trials of surgery for spontaneous ICH (including the STICH II trial), but none so far of surgery for TICH. METHODS/DESIGN: The UK National Institutes of Health Research has funded STITCH(Trauma) to determine whether a policy of early surgery in patients with TICH improves outcome compared to a policy of initial conservative treatment. It will include a health economics component and carry out a subgroup analysis of patients undergoing invasive monitoring. This is an international multicenter pragmatic randomized controlled trial.Patients are eligible if: they are within 48 h of injury; they have evidence of TICH on CT scan with a confluent volume of attenuation significantly raised above that of the background white and grey matter that has a total volume >10 mL; and their treating neurosurgeon is in equipoise.Patients will be ineligible if they have: a significant surface hematoma (EDH or SDH) requiring surgery; a hemorrhage/contusion located in the cerebellum; three or more separate hematomas fulfilling inclusion criteria; or severe pre-existing physical or mental disability or severe co-morbidity which would lead to poor outcome even if the patient made a full recovery from the head injury.Patients will be randomized via an independent service. Patients randomized to surgery receive surgery within 12 h. Both groups will be monitored according to standard neurosurgical practice. All patients have a CT scan at 5 days (+/-2 days) to assess changes in hematoma size. Follow-up is by postal questionnaire at 6 and 12 months. The recruitment target is 840 patients. TRIAL REGISTRATION: Current Controlled Trials ISRCTN19321911.

Multicenter clinical assessment of the Raumedic Neurovent-P intracranial pressure sensor: a report by the BrainIT group.

OBJECTIVE: The aim of this study was to evaluate the robustness and zero-drift of an intracranial pressure sensor, Neurovent-P (Raumedic AG, Münchberg, Germany), when used in the clinical environment. METHODS: A prospective multicenter trial, conforming to the International Organization for Standardization 14155 Standard, was conducted in 6 European BrainIT centers between July 2005 and December 2006. Ninety-nine catheters were used. The study was observational, followed by a centralized sensor bench test after catheter removal. RESULTS: The mean recorded value before probe insertion was 0.17 +/- 1.1 mm Hg. Readings outside the range +/-1 mm Hg were recorded in only 3 centers on a total of 15 catheters. Complications were minimal and mainly related to the insertion bolt. The mean recorded pressure value at removal was 0.8 +/- 2.2 mm Hg. No relationship was identified between postremoval reading and length of monitoring. The postremoval bench test indicated the probability of a system failure, defined as a drift of more than 3 mm Hg, at a range between 12 and 17%. CONCLUSION: The Neurovent-P catheter performed well in clinical use in terms of robustness. The majority of technical complications were associated with the bolt fixation technology. Adverse events were rare and clinically nonsignificant. Despite the earlier reported excellent bench test zero-drift rates, under the more demanding clinical conditions, zero-drift rate remains a concern with catheter tip strain gauge technology. This performance is similar, and not superior, to other intracranial pressure devices.

Blood pressure in head-injured patients.

OBJECTIVE: To determine the statistical characteristics of blood pressure (BP) readings from a large number of head-injured patients. METHODS: The BrainIT group has collected high time-resolution physiological and clinical data from head-injured patients who require intracranial pressure (ICP) monitoring. The statistical features of this dataset of BP measurements with time resolution of 1 min from 200 patients is examined. The distributions of BP measurements and their relationship with simultaneous ICP measurements are described. RESULTS: The distributions of mean, systolic and diastolic readings are close to normal with modest skewing towards higher values. There is a trend towards an increase in blood pressure with advancing age, but this is not significant. Simultaneous blood pressure and ICP values suggest a triphasic relationship with a BP rising at 0.28 mm Hg/mm Hg of ICP, for ICP up to 32 mm Hg, and 0.9 mm Hg/mm Hg of ICP for ICP from 33 to 55 mm Hg, and falling sharply with rising ICP for ICP >55 mm Hg. CONCLUSIONS: Patients with head injury appear to have a near normal distribution of blood pressure readings that are skewed towards higher values. The relationship between BP and ICP may be triphasic.

What is the optimal cerebral perfusion pressure in children suffering from traumatic coma?

Head injury is a major cause of death and disability in children. Despite advances in resuscitation, emergency care, intensive care monitoring, and clinical practices, there are few data demonstrating the predictive value of certain physiological variables regarding outcome in this patient population. Mean arterial blood pressure (MABP), intracranial pressure (ICP), and cerebral perfusion pressure (CPP = MABP - ICP) are routinely monitored in patients in many neurological intensive care units throughout the world, but there is little evidence indicating that advances in care have been matched with corresponding improvements in outcome. Nonetheless, there is evidence that hypotension immediately following head injury is predictive of early death, and many patients with these features die with clinical signs of brain herniation caused by intracranial hypertension. Furthermore, available data indicate that a minimal and a mean CPP measured during intensive care are good predictors of outcome in survivors, but a target threshold to improve outcome has yet to be defined. Some medical management strategies can have detrimental effects, and there is now a good case for undertaking a controlled trial of immediate or delayed craniectomy. Independent outcome in children following severe head injury is associated with higher levels of CPP. The ability to tolerate different levels of CPP may be related to age, and therefore any such surgical trial would need a carefully defined protocol so that the potential benefit of such a treatment is maximized.