Displaying publications 1 - 20 of 61 in total

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  1. Veeramuthu V, Seow P, Narayanan V, Wong JHD, Tan LK, Hernowo AT, et al.
    Acad Radiol, 2018 09;25(9):1167-1177.
    PMID: 29449141 DOI: 10.1016/j.acra.2018.01.005
    RATIONALE AND OBJECTIVES: Magnetic resonance spectroscopy is a noninvasive imaging technique that allows for reliable assessment of microscopic changes in brain cytoarchitecture, neuronal injuries, and neurochemical changes resultant from traumatic insults. We aimed to evaluate the acute alteration of neurometabolites in complicated and uncomplicated mild traumatic brain injury (mTBI) patients in comparison to control subjects using proton magnetic resonance spectroscopy (1H magnetic resonance spectroscopy).

    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 

    Matched MeSH terms: Glasgow Coma Scale
  2. Azian AA, Nurulazman AA, Shuaib L, Mahayidin M, Ariff AR, Naing NN, et al.
    Acta Neurochir (Wien), 2001;143(7):711-20.
    PMID: 11534693
    Head injury is a significant economic, social and medical problem all over the world. Road accidents are the most frequent cause of head injury in Malaysia with highest risk in the young (15 to 24 years old). The associated outcomes include good recovery, possibility of death for the severely injured, which may cause disruption of the lives of their family members. It is important to predict the outcome as it will provide sound information to assist clinicians in Malaysia in providing prognostic information to patients and their families, to assess the effectiveness of different modes of treatment in promoting recovery and to document the significance of head injury as a public health problem.

    RESULTS: A total of 103 cases with intracranial haemorrhage i.e. intracerebral haemorrhage, extradural haemorrhage, subdural haemorrhage, intraventricular haemorrhage, haemorrhagic contusion and subarachnoid haemorrhage, following motor vehicle accidents was undertaken to study factors contributing to either good or poor outcome according to the Glasgow Outcome Scale. Patients below 12 years of age were excluded. The end point of the study was taken at 24 months post injury. The selected variables were incorporated into models generated by logistic regression techniques of multivariate analysis to see the significant predictors of outcome as well as the correlation between the CT findings with GCS.

    CONCLUSION: Significant predictors of outcome were GCS on arrival in the accident emergency department, pupillary reflex and the CT scan findings. The CT predictors of outcome include ICH, EDH, IVH, present of SAH, site of ICH, volumes of EDH and SDH as well as midline shift.

    Matched MeSH terms: Glasgow Coma Scale
  3. Abdullah JM, Husin A
    Acta Neurochir. Suppl., 2011;111:421-4.
    PMID: 21725794 DOI: 10.1007/978-3-7091-0693-8_72
    The use of intravascular hypothermia in the treatment of hemorrhagic stroke is currently still being researched. The exact therapeutic properties and effect of hypothermia on the natural progression of the disease are not known, and a only small number of papers has been published with results from these studies. Mild hypothermia at 34°C was induced in six patients with hemorrhagic stroke in the first 48 h after presentation, using an intravascular catheter placed in the inferior vena cava. The hypothermia was induced and maintained for 24 h followed by gradual rewarming. Another 18 patients with hemorrhagic stroke but not receiving hypothermia were then taken as the control group, and all patients were treated with standard stroke management. The patients were then followed up using the modified Rankin Scale (mRS) for 6 months and 1 year. There was a statistically significant improvement at 6 months and 1 year follow-up using the mRS score in the hypothermia group, indicating a possible beneficial effect of early therapeutic hypothermia in the management of acute hemorrhagic stroke. However, a larger study is needed in order to confirm our finding.
    Matched MeSH terms: Glasgow Coma Scale
  4. Keong LH, Ghani AR, Awang MS, Sayuthi S, Idris B, Abdullah JM
    Acta Neurochir. Suppl., 2011;111:375-9.
    PMID: 21725785 DOI: 10.1007/978-3-7091-0693-8_63
    The aim of the study was to determine the prognostic value of a high augmentation index, which was a surrogate marker of arterial stiffness in patients with spontaneous intracerebral hemorrhage. The outcome was divided into two groups in which the following data were collected in a computer running SphygmoCor CvMS software version 8.2. Logistic regression analysis was carried out among significant variables to identify an independent predictor of 6-month outcome and mortality. Sixty patients were recruited into the study. Admission Glasgow Coma Scale score (OR, 0.7; 95% CI, 0.450-0.971; P=0.035), total white cell count (OR, 1.2; 95% CI, 1.028-1.453; P=0.023) and hematoma volume (OR, 1.1; 95% CI, 1.024-1.204; P=0.011) were found to be statistically significant for identifying poor 6-month outcome in multivariate analysis. Factors independently associated with mortality were a high augmentation index (OR, 8.6; 95% CI, 1.794-40.940; P=0.007) and midline shift (OR, 7.5; 95% CI, 1.809-31.004; P=0.005). Admission Glasgow Coma Scale score, total white cell count and hematoma volume were significant predictors for poor 6-month outcome, and a high augmentation index and midline shift were predictors for 6-month mortality in this study.
    Matched MeSH terms: Glasgow Coma Scale
  5. Sam JE, Gee TS, Wahab NA
    Asian J Neurosurg, 2018 3 2;13(1):56-58.
    PMID: 29492121 DOI: 10.4103/1793-5482.185056
    Dengue fever has been a major cause of morbidity and mortality in subtropical and tropical countries. We report a rare case of severe dengue with spontaneous intracranial hemorrhage. A search of literature through PubMed revealed that the largest series analyzed so far only included five cases. A 47-year-old man presented with 7 days history of fever, headache, myalgia, and vomiting with hematemesis. On the day of presentation, he had reduced consciousness and an episode of generalized tonic-clonic seizure. His Glasgow Coma Scale was E1V1M3 with anisocoria. Postresuscitation computed tomography of the brain revealed a right subdural and left thalamic hemorrhage. His blood investigations revealed thrombocytopenia, dengue virus type 1 nonstructural protein antigen test was positive, dengue IgM negative, and dengue IgG positive. A right decompressive craniectomy was done. Unfortunately, the patient died soon after. Spontaneous intracranial hemorrhage in patients with dengue fever is an uncommon entity but usually carry a grave prognosis. To date, there has been no clear management guideline for such cases, as both operative and nonoperative approaches have their own inherent risks.
    Matched MeSH terms: Glasgow Coma Scale
  6. Idris Z, Zenian MS, Muzaimi M, Hamid WZ
    Asian J Neurosurg, 2014 Jul-Sep;9(3):115-23.
    PMID: 25685201 DOI: 10.4103/1793-5482.142690
    Induced hypothermia for treatment of traumatic brain injury is controversial. Since many pathways involved in the pathophysiology of secondary brain injury are temperature dependent, regional brain hypothermia is thought capable to mitigate those processes. The objectives of this study are to assess the therapeutic effects and complications of regional brain cooling in severe head injury with Glasgow coma scale (GCS) 6-7.
    Matched MeSH terms: Glasgow Coma Scale
  7. Lee HK, Ghani AR, Awang MS, Sayuthi S, Idris B, Abdullah JM
    Asian J Surg, 2010 Jan;33(1):42-50.
    PMID: 20497882 DOI: 10.1016/S1015-9584(10)60008-5
    Intracerebral haemorrhage (ICH) is the most disabling and least treatable form of stroke. Its risk factors include old age, hypertension, diabetes mellitus, hypercholesterolaemia, smoking and high alcohol intake, which are also associated with arterial stiffness. The aim of the present study was to determine the prognostic value of high augmentation index (AI), which is a surrogate marker of arterial stiffness, in patients with spontaneous ICH.
    Matched MeSH terms: Glasgow Coma Scale
  8. Abdullah JM, Kumaraswamy N, Awang N, Ghazali MM, Abdullah MR
    Asian J Surg, 2005 Jul;28(3):163-7.
    PMID: 16024307
    To use data from a prospective, longitudinal study to determine whether psychomotor functions improve spontaneously during the first year following paediatric traumatic brain injury without modern rehabilitation facilities in a rural area of Malaysia.
    Matched MeSH terms: Glasgow Coma Scale
  9. Shadli RM, Pieter MS, Yaacob MJ, Rashid FA
    Brain Inj, 2011;25(6):596-603.
    PMID: 21534737 DOI: 10.3109/02699052.2011.572947
    The influence of apolipoprotein (APOE) on neuropsychological outcome was investigated in 19 patients (25.79 ± 7.22 years) with mild-to-moderate traumatic brain injury and 14 matched healthy control subjects (27.43 ± 6.65 years).
    Matched MeSH terms: Glasgow Coma Scale
  10. Selladurai BM, Jayakumar R, Tan YY, Low HC
    Br J Neurosurg, 1992;6(6):549-57.
    PMID: 1472321
    The outcome of 109 patients with severe head injury was studied in relation to clinical and computed tomographic (CT) criteria on admission, after resuscitation. Age, Glasgow Coma Score (GCS) and state of pupils strongly correlated with outcome. The presence of hypothalamic disturbances, hypoxia and hypotension were associated with an adverse outcome. The CT indicators associated with poor outcome were perimesencephalic cistern (PMC) obliteration, subarachnoid haemorrhage, diffuse axonal injury and acute subdural haematoma. The prognostic value of midline shift and mass effect were influenced by concomitant presence of diffuse brain injury. For the subset of patients aged < 20 years, with GCS 6-8 and patent PMC (n = 21), 71.4% correct predictions were made for a good outcome. For the subset of patients aged > 20 years, with GCS 3-5 and partial or complete obliteration of PMC (n = 28), 89.3% correct predictions were made for a poor outcome.
    Matched MeSH terms: Glasgow Coma Scale
  11. Selladurai BM, Vickneswaran M, Duraisamy S, Atan M
    Br J Neurosurg, 1997 Oct;11(5):398-404.
    PMID: 9474270
    The aim of this investigation was to determine the prognostic value of coagulation abnormalities in a defined subset of patients with acute head injury. Prothrombin time, accelerated partial thromboplastin time (APTT), thrombin clotting time, fibrinogen assay, platelet count, fibrin degradation products (FDP) were assayed in 204 patients with acute closed head injury. Their values were graded on a score 0-3 and the sum score for each patient regarded as the disseminated intravascular coagulation (DIC) score. Moderate to severe DIC scores were evident in 38% of the cohort. At least one parameter was abnormal in 71% of patients. The DIC score correlated inversely with the Glasgow coma score (GCS) (p < 0.0001). In the GCS 13-15 subset, FDP scores were significant predictors of poor outcome (p < 0.001). In the GCS 6-12 subset, the APTT score (p < 0.001), and DIC score (p < 0.0001) predicted an adverse outcome. The DIC scores were significantly abnormal in most patients who had a poor outcome, without evidence of adverse predictors on CT. Logistic regression analysis confirmed the independent predictive capacity of APTT, FDP and DIC scores when values for GCS were fixed. Abnormal haemostatic parameters may enhance the predictive ability in subsets of patients with acute head injury defined by clinical or CT predictors.
    Matched MeSH terms: Glasgow Coma Scale
  12. Abdullah MI, Ahmad A, Syed Saadun Tarek Wafa SWW, Abdul Latif AZ, Mohd Yusoff NA, Jasmiad MK, et al.
    Chin J Traumatol, 2020 Oct;23(5):290-294.
    PMID: 32423779 DOI: 10.1016/j.cjtee.2020.04.004
    PURPOSE: Malnutrition is a common problem among hospitalized patients, especially among traumatic brain injury (TBI) patients. It is developed from hypermetabolism and the condition may worsen under the circumstance of underfeeding or incompatible dietary management. However, the data of nutrient intake especially calorie and protein among TBI patients were scarce. Hence, this study aimed to determine the calorie and protein intake among acute and sub-acute TBI patients receiving medical nutrition therapy in hospital Sultanah Nur Zahirah, Terengganu.

    METHODS: This observational study involved 50 patients recruited from the neurosurgical ward. Method of 24 h dietary recall was utilized and combined with self-administered food diaries for 2-8 days. Food consumptions including calorie intake and protein intake were analyzed using Nutritionist PRO™ (Woodinville, USA) and manual calculation based on the Malaysian food composition database (2015).

    RESULTS: Patients consisted of 56% males and 44% females with the median age of 28.0 (IQR = 22.8-36.5) years, of which 92% were diagnosed as mild TBI and the remaining (8%) as moderate TBI. The Glasgow coma scale (GCS) was adopted to classify TBI severity with the score 13-15 being mild and 9-12 being moderate. The median length of hospital stay was 2 (IQR = 2.0-3.3) days. Calorie and protein intake improved significantly from day 1 to discharge day. However, the intake during discharge day was still considered as suboptimal, i.e. 75% of calorie requirement, whilst the median protein intake was only 61.3% relative to protein requirement. Moreover, the average percentages of calorie and protein intakes throughout hospitalization were remarkably lower, i.e. 52.2% and 41.0%, respectively.

    CONCLUSION: Although the calorie and protein intakes had increased from baseline, hospitalized TBI patients were still at a risk to develop malnutrition as the average intakes were considerably low as compared to their requirements. Optimum nutrient intakes especially calorie and protein are crucial to ensure optimum recovery process as well as to minimize risks of infection and complications.

    Matched MeSH terms: Glasgow Coma Scale
  13. Vijian K, Teo EG, Kanesen D, Wong ASH
    PMID: 32922934 DOI: 10.1186/s41016-020-0185-4
    Background: Globally, severe traumatic brain injury (TBI) has been the principal cause of mortality among individuals aged 45 and below. The incidence of road traffic accidents in Malaysia is one of the highest in the world with thousands of victims sustaining severe disabilities. The aim of this study is to determine the association between leucocytosis and extended Glasgow Outcome Scale (GOSE) scores as well the relationship of other factors and the outcomes of severe TBI.

    Methods: This was a retrospective observational study. A total of 44 consecutive patients who were admitted to Sarawak General Hospital from January 1, 2018, to September 30, 2018, with severe TBI were included. Data were collected from discharge summaries and hospital medical records. Chi-square and t test were used. SPSS was employed.

    Results: Of a total of 44 patients with severe TBI, 18 patients (41%) died during the same admission. The mean age of patients was 37.1 years with 93.2% of affected patients being male. 56.9% of patients presented with a Glasgow Coma Scale (GCS) of 6 and less. A large percentage (86.3%) were discharged with a GOSE of less than 7. Older age and low admission GCS (6 and less) were significantly associated with poor GOSE scores on discharge and after 6 months (p < 0.05) on multivariate analysis. Leucocytosis on admission was also associated with poor outcomes where patients with higher total white counts on presentation attaining lower GOSE scores (p < 0.05).

    Conclusion: We concluded that leucocytosis was significantly associated with poor outcomes in severe TBI patients in addition to other factors such as advanced age and poor GCS on arrival.

    Matched MeSH terms: Glasgow Coma Scale
  14. Ooi MH, Lewthwaite P, Lai BF, Mohan A, Clear D, Lim L, et al.
    Clin Infect Dis, 2008 Aug 15;47(4):458-68.
    PMID: 18616397 DOI: 10.1086/590008
    BACKGROUND: Japanese encephalitis is a major public health problem in Asia. However, there is little data on the long-term outcome of Japanese encephalitis survivors.

    METHODS: We prospectively evaluated children with serologically confirmed Japanese encephalitis over an 8.3-year period. The patients were assessed and their outcomes were graded with a functional outcome score at hospital discharge and at follow-up appointments. We examined how patient outcome at hospital discharge compared with that at long-term follow-up visits, when changes in outcome occurred, and the prognostic indicators of the eventual outcome.

    RESULTS: One hundred and eighteen patients were recruited into the study, and 10 (8%) died during the acute phase of illness. At hospital discharge, 44 (41%) of the 108 patients who survived had apparent full recovery; 3 (3%) had mild, 28 (26%) had moderate, and 33 (31%) had severe neurological sequelae. Eighty six of the 108 patients were followed up for a median duration of 52.9 months (range, 0.9-114.9 months). During follow-up, 31 patients experienced improvement, but 15 patients experienced deterioration in their outcome grade. In most cases, assessment during the first 3-6 months after hospital discharge was predictive of the long-term outcome. More than one-half of the patients continued to experience neuropsychological sequelae and behavioral disorders. A combination of poor perfusion, Glasgow coma score < or =8, and > or =2 witnessed seizures predicted a poor long-term outcome with 65% sensitivity and 92% specificity.

    CONCLUSIONS: Neurological assessment of Japanese encephalitis survivors at hospital discharge does not predict long-term outcome. Seizures and shock are treatable risk factors for a poor outcome at hospital discharge and at long-term follow-up visits.

    Matched MeSH terms: Glasgow Coma Scale
  15. Mohamed Ludin S, Abdul Rashid N
    Clin Nurs Res, 2020 09;29(7):433-439.
    PMID: 30079766 DOI: 10.1177/1054773818792459
    Throughout recovery, patients with severe traumatic brain injury (TBI) show physical and functional improvement, but continue to have cognitive and psychosocial problems. The aim of this article was to review the literature regarding the functional and health-related quality of life (HRQOL) outcomes in severe TBI. There were 15 articles reviewed, 13 of them were quantitative studies and two were narrative review. Most of the articles showed an improvement occurs rapidly at 6 months post-injury. There were several factors that influence the outcome after TBI, most of it was the Glasgow Coma Scale (GCS) on admission, age, educational level, duration of posttraumatic amnesia (PTA), and length of stay (LOS) in the Intensive Care Unit (ICU). Thus, health care workers should help the survivors of severe TBI in the recovery process to ensure the latter can attain maximum function and quality of life.
    Matched MeSH terms: Glasgow Coma Scale
  16. Abosadegh MM, Rahman SA, Saddki N
    Dent Traumatol, 2017 Oct;33(5):369-374.
    PMID: 28504848 DOI: 10.1111/edt.12349
    BACKGROUND/AIMS: The association of traumatic head injury (THI) with maxillofacial fractures (MFF) is a major health concern worldwide. In spite of the close anatomical proximity of maxillofacial bones to the cranium, the association of THI with MFF is controversial. The aim of this study was to assess the association between THI and MFF. Other factors associated with THI in patients with MFF were also investigated.

    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

    Matched MeSH terms: Glasgow Coma Scale
  17. Anada RP, Wong KT, Jayapalan JJ, Hashim OH, Ganesan D
    Electrophoresis, 2018 09;39(18):2308-2315.
    PMID: 29570807 DOI: 10.1002/elps.201700407
    The Glasgow Coma Scale (GCS), which classifies patients into mild, moderate or severe traumatic brain injury (TBI), is a system used to prioritize treatment and prognosticate the severity of head injury. In this study, sera of patients with various stages of TBI, as well as control subjects, were analyzed to screen for proteins that may be used to complement the GCS system. By subjecting pooled serum samples to iTRAQ analysis for quantitative comparison of protein abundance, and attesting their altered levels using ELISA, we have detected increased levels of serum amyloid A, C-reactive protein, leucine-rich alpha-2-glycoprotein, lipopolysaccharide-binding protein, fibronectin, vitronectin and alpha-1-antichymotrypsin in patients across all strata of TBI relative to the controls. However, kininogen was decreased only in moderate and severe TBI, whereas apolipoprotein E and zinc-alpha-2-glycoprotein were only increased in severe TBI. Hence, we propose a panel of serum biomarkers, which if analyzed within 24 h of the injury, can be used to diagnose patients with TBI into mild, moderate or severe stratification objectively, thus complementing the traditional GCS.
    Matched MeSH terms: Glasgow Coma Scale
  18. Mohd Nor NS, Fong CY, Rahmat K, Vanessa Lee WM, Zaini AA, Jalaludin MY
    Eur Endocrinol, 2018 Apr;14(1):59-61.
    PMID: 29922355 DOI: 10.17925/EE.2018.14.1.59
    Cerebral oedema is the most common neurological complication of diabetic ketoacidosis (DKA). However, ischaemic and haemorrhagic brain injury has been reported infrequently. A 10-year old girl who was previously well presented with severe DKA. She was tachycardic with poor peripheral perfusion but normotensive. However, two fast boluses totalling 40 ml/kg normal saline were given. She was transferred to another hospital where she was intubated due to drowsiness. Rehydration fluid (maintenance and 48-hour correction for 7.5% dehydration) was started followed by insulin infusion. She was extubated within 24 hours of admission. Her ketosis resolved soon after and subcutaneous insulin was started. However, about 48 hours after admission, her Glasgow Coma Scale score dropped to 11/15 (E4M5V2) with expressive aphasia and upper motor neuron signs. One dose of mannitol was given. Her symptoms improved gradually and at 26-month follow-up she had a near-complete recovery with only minimal left lower limb weakness. Serial magnetic resonance imaging brain scans showed vascular ischaemic injury at the frontal-parietal watershed regions with haemorrhagic transformation. This case reiterates the importance of monitoring the neurological status of patient's with DKA closely for possible neurological complications including an ischaemic and haemorrhagic stroke.
    Matched MeSH terms: Glasgow Coma Scale
  19. Law ZK, Meretoja A, Engelter ST, Christensen H, Muresan EM, Glad SB, et al.
    Eur Stroke J, 2017 Mar;2(1):13-22.
    PMID: 31008298 DOI: 10.1177/2396987316676610
    Purpose: Haematoma expansion is a devastating complication of intracerebral haemorrhage (ICH) with no established treatment. Tranexamic acid had been an effective haemostatic agent in reducing post-operative and traumatic bleeding. We review current evidence examining the efficacy of tranexamic acid in improving clinical outcome after ICH.

    Method: We searched MEDLINE, EMBASE, CENTRAL and clinical trial registers for studies using search strategies incorporating the terms 'intracerebral haemorrhage', 'tranexamic acid' and 'antifibrinolytic'. Authors of ongoing clinical trials were contacted for further details.

    Findings: We screened 268 publications and retrieved 17 articles after screening. Unpublished information from three ongoing clinical trials was obtained. We found five completed studies. Of these, two randomised controlled trials (RCTs) comparing intravenous tranexamic acid to placebo (n = 54) reported no significant difference in death or dependency. Three observational studies (n = 281) suggested less haematoma growth with rapid tranexamic acid infusion. There are six ongoing RCTs (n = 3089) with different clinical exclusions, imaging selection criteria (spot sign and haematoma volume), time window for recruitment and dosing of tranexamic acid.

    Discussion: Despite their heterogeneity, the ongoing trials will provide key evidence on the effects of tranexamic acid on ICH. There are uncertainties of whether patients with negative spot sign, large haematoma, intraventricular haemorrhage, or poor Glasgow Coma Scale should be recruited. The time window for optimal effect of haemostatic therapy in ICH is yet to be established.

    Conclusion: Tranexamic acid is a promising haemostatic agent for ICH. We await the results of the trials before definite conclusions can be drawn.

    Matched MeSH terms: Glasgow Coma Scale
  20. Sprigg N, Flaherty K, Appleton JP, Al-Shahi Salman R, Bereczki D, Beridze M, et al.
    Health Technol Assess, 2019 07;23(35):1-48.
    PMID: 31322116 DOI: 10.3310/hta23350
    BACKGROUND: Tranexamic acid reduces death due to bleeding after trauma and postpartum haemorrhage.

    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.

    Matched MeSH terms: Glasgow Coma Scale
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