OBJECTIVE: The aim of the study was to assess if tranexamic acid is safe, reduces haematoma expansion and improves outcomes in adults with spontaneous intracerebral haemorrhage (ICH).
DESIGN: The TICH-2 (Tranexamic acid for hyperacute primary IntraCerebral Haemorrhage) study was a pragmatic, Phase III, prospective, double-blind, randomised placebo-controlled trial.
SETTING: Acute stroke services at 124 hospitals in 12 countries (Denmark, Georgia, Hungary, Ireland, Italy, Malaysia, Poland, Spain, Sweden, Switzerland, Turkey and the UK).
PARTICIPANTS: Adult patients (aged ≥ 18 years) with ICH within 8 hours of onset.
EXCLUSION CRITERIA: Exclusion criteria were ICH secondary to anticoagulation, thrombolysis, trauma or a known underlying structural abnormality; patients for whom tranexamic acid was thought to be contraindicated; prestroke dependence (i.e. patients with a modified Rankin Scale [mRS] score > 4); life expectancy Glasgow Coma Scale score of 4.5 hours after stroke onset. Pragmatic inclusion criteria led to a heterogeneous population of participants, some of whom had very large strokes. Although 12 countries enrolled participants, the majority (82.1%) were from the UK.
CONCLUSIONS: Tranexamic acid did not affect a patient's functional status at 90 days after ICH, despite there being significant modest reductions in early death (by 7 days), haematoma expansion and SAEs, which is consistent with an antifibrinolytic effect. Tranexamic acid was safe, with no increase in thromboembolic events.
FUTURE WORK: Future work should focus on enrolling and treating patients early after stroke and identify which participants are most likely to benefit from haemostatic therapy. Large randomised trials are needed.
TRIAL REGISTRATION: Current Controlled Trials ISRCTN93732214.
FUNDING: This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 35. See the NIHR Journals Library website for further project information. The project was also funded by the Pragmatic Trials, UK, funding call and the Swiss Heart Foundation in Switzerland.
METHOD: A total of 3825 trauma patients from 2011 to 2016 were extracted from the Hospital Sultanah Aminah Trauma Surgery Registry. Patients were split into a development sample (n = 2683) and a validation sample (n = 1142). Univariate analysis is applied to identify significant anatomic predictors. These predictors were further analyzed using multivariable logistic regression to develop the new score and compared to existing score systems. The quality of prediction was determined regarding discrimination using sensitivity, specificity and receiver operating characteristic [ROC] curve.
RESULTS: Existing simplified score systems (GAP & mGAP) revealed areas under the ROC curve of 0.825 and 0.806. The newly developed HeCLLiP (Head, cervical spine, lung, liver, pelvic fracture) score combines only five anatomic components: injury involving head, cervical spine, lung, liver and pelvic bone. The probabilities of mortality can be estimated by charting the total score points onto a graph chart or using the cut-off value of (>2) with a sensitivity of 79.2 and specificity of 70.6% on the validation dataset. The HeCLLiP score achieved comparable values of 0.802 for the area under the ROC curve in validation samples.
CONCLUSION: HeCLLiP Score is a simplified anatomic score suited to the local Malaysian population with a good predictive ability for trauma mortality.
MATERIALS AND METHODS: A hospital-based retrospective study was conducted at the OMFS Unit, Hospital USM, Kelantan, Malaysia. From 12 June 2013 to 31 December 2015, 473 patient records with MFF were reviewed to evaluate the association of THI and MFF.
RESULTS: A total of 331 patients (69.98%) presented with concomitant THI. The most common associated THI were cranial bone fractures (68.6%) followed by intracranial injuries and concussion. A significant association existed between the Glasgow coma scale (GCS) score and the presence of THI concomitant MFF with P-value
MATERIAL AND METHODS: Forty-eight subjects (23 complicated mTBI [cmTBI] patients, 12 uncomplicated mTBI [umTBI] patients, and 13 controls) underwent magnetic resonance imaging scan with additional single voxel spectroscopy sequence. Magnetic resonance imaging scans for patients were done at an average of 10 hours (standard deviation 4.26) post injury. The single voxel spectroscopy adjacent to side of injury and noninjury regions were analysed to obtain absolute concentrations and ratio relative to creatine of the neurometabolites. One-way analysis of variance was performed to compare neurometabolite concentrations of the three groups, and a correlation study was done between the neurometabolite concentration and Glasgow Coma Scale.
RESULTS: Significant difference was found in ratio of N-acetylaspartate to creatine (NAA/Cr + PCr) (χ2(2) = 0.22, P Glasgow Coma Scale with NAA/Cr + PCr (ρ = 0.36, P
AIMS: This study was performed to evaluate and compare the oxidative changes in patients with varying severity of HI in the early posttraumatic period using erythrocyte indicators.
SETTINGS AND DESIGN: Head injury patients were divided into two groups based on their Glasgow Coma Scale (GCS) scores recorded at admission to the hospital on the day of trauma itself. Accordingly, the study included 30 severe HI (SHI, GCS scores 8 or less) and 25 Mild HI (MHI, GCS scores more than 8) patients. Thirty age and sex-matched healthy individuals were included in this comparative study as controls.
MATERIALS AND METHODS: Blood samples were obtained from controls and HI patients (within 24 h of trauma onset). Erythrocyte oxidative changes were studied by estimating thiobarbituric acid reactive substances (TBARS), glutathione (GSH), superoxide dismutase (SOD) and glutathione reductase (GR).
RESULTS: Erythrocyte TBARS levels were significantly higher and GSH levels were significantly lower in SHI and MHI patients as compared to controls. The SOD activity was significantly increased only in SHI patients and remained unchanged in MHI patients as compared to controls. As compared to MHI patients, erythrocyte TBARS levels were significantly higher, GSH levels were significantly lower and SOD activity was markedly elevated in SHI patients. Erythrocyte GR activity did not show significant changes in both groups of patients as compared to controls.
CONCLUSION: Oxidative stress is evident in both SHI and MHI patients in the early posttraumatic period as reflected by their erythrocyte indicators, but the severity of oxidative stress has varied relatively with the severity of head injury. The present findings provide indications that early oxidative changes could influence the neurological recovery of HI patients.
METHODS: Twenty-nine children in each group, matched for age, sex and ethnicity, were assessed using the Glasgow outcome Scale (GOS), Weschler Intelligence Scale for Children (WISC-III), Movement Assessment Battery for Children (Movement ABC), Wide Range Assessment of Learning and Memory (WRAML) and a standardised neurological examination 6 months post-injury. Parental reporting of pre- and post-injury behaviour was documented using the Child Behaviour Checklist (CBCL).
RESULTS: Seven (24.1%) children with sCHI and three (10.3%) orthopaedic controls had residual motor deficits. Three (10.3%) children with sCHI and none in the other groups faced problems with independent ambulation. Twenty-seven (93.1%) of those with sCHI and all children in the other groups had GOS scores of good recovery or moderate disability. Twenty-two (81.5%) sCHI, five (18.5%) mCHI and one (3.7%) orthopaedic control reported a deterioration in school performance. MANOVAS identified a significant injury group effect for performance skills (P = 0.007), verbal skills (P = 0.002), memory and learning (P = 0.001) and motor skills (P = 0.001). Repeated measures ANOVA for pre- and post-injury CBCL scores showed significant differences related to somatic complaints (P = 0.004), problems of socialising (P = 0.003), delinquency (P = 0.004), aggressiveness (P = 0.010), thought (P < 0.001) and attention (P < 0.001). Post-hoc univariate analysis showed the significant differences were between that of the sCHI children and the other two groups.
CONCLUSION: Although most sCHI children seemed to have made good physical recovery, there were cognitive, motor, memory and learning difficulties and behavioural problems concomitant with a deterioration in school performance compared with those with lesser or no head injury. This highlights the need for better integrated rehabilitation services to enable a gradual return into mainstream school.