Displaying publications 1 - 20 of 82 in total

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  1. Lee YM, Wang SF, Lee CM, Chen KH, Chan YJ, Liu WT, et al.
    BMC Res Notes, 2009;2:86.
    PMID: 19426542 DOI: 10.1186/1756-0500-2-86
    From October 2006 to February 2007, clinical specimens from 452 patients with symptoms related to respiratory tract infection in the northern region of Taiwan were collected. Real-time PCR and direct immunofluorescent antibody tests showed that 145 (32%) patients had influenza B virus infections. Subsequently, nucleotide sequence analyses of both hemagglutinin (HA) and neuraminidase (NA) genes of 39 isolates were performed. Isolated viruses were antigenically characterized using hemagglutinin inhibition (HI) test.
  2. Othman A, Goggin KA, Tahir NI, Brodrick E, Singh R, Sambanthamurthi R, et al.
    BMC Res Notes, 2019 Apr 16;12(1):229.
    PMID: 30992056 DOI: 10.1186/s13104-019-4263-7
    OBJECTIVE: The addition of residual oils such as palm fibre oil (PFO) and sludge palm oil (SPO) to crude palm oil (CPO) can be problematic within supply chains. PFO is thought to aggravate the accumulation of monochloropropanediols (MCPDs) in CPO, whilst SPO is an acidic by-product of CPO milling and is not fit for human consumption. Traditional targeted techniques to detect such additives are costly, time-consuming and require highly trained operators. Therefore, we seek to assess the use of gas chromatography-ion mobility spectrometry (GC-IMS) for rapid, cost-effective screening of CPO for the presence of characteristic PFO and SPO volatile organic compound (VOC) fingerprints.

    RESULTS: Lab-pressed CPO and commercial dispatch tank (DT) CPO were spiked with PFO and SPO, respectively. Both additives were detectable at concentrations of 1% and 10% (w/w) in spiked lab-pressed CPO, via seven PFO-associated VOCs and 21 SPO-associated VOCs. DT controls could not be distinguished from PFO-spiked DT CPO, suggesting these samples may have already contained low levels of PFO. DT controls were free of SPO. SPO was detected in all SPO-spiked dispatch tank samples by all 21 of the previously distinguished VOCs and had a significant fingerprint consisting of four spectral regions.

  3. Thomas S, Subramaniam S, Abraham M, Too L, Beh L
    BMC Res Notes, 2011;4:337.
    PMID: 21902839 DOI: 10.1186/1756-0500-4-337
    This is a pilot cross sectional study using both quantitative and qualitative approach towards tutors teaching large classes in private universities in the Klang Valley (comprising Kuala Lumpur, its suburbs, adjoining towns in the State of Selangor) and the State of Negeri Sembilan, Malaysia. The general aim of this study is to determine the difficulties faced by tutors when teaching large group of students and to outline appropriate recommendations in overcoming them.
  4. Mad' Atari MFB, Folta KM
    BMC Res Notes, 2019 Mar 15;12(1):144.
    PMID: 30876440 DOI: 10.1186/s13104-019-4117-3
    OBJECTIVE: The treatment of plant tissue with Agrobacterium tumefaciens is often a critical first step to both stable and transient plant transformation. In both applications bacterial suspensions are oftentimes physically introduced into plant tissues using hand-driven pressure from a needleless syringe. While effective, this approach has several drawbacks that limit reproducibility. Pressure must be provided with the syringe perfectly perpendicular to the tissue surface. The researcher must also attempt to provide even and consistent pressure, both within and between experimental replicates. These factors mean that the procedures do not always translate well between research groups or biological replicates.

    RESULTS: We have devised a method to introduce Agrobacterium suspensions into plant leaves with greater reproducibility. Using a decommissioned dissecting microscope as an armature, a syringe body with the bacterial suspension is mounted to the nosepiece. Gentle, even pressure is applied by rotating the focus knob. The treatment force is measured using a basic kitchen scale. The development of the Standardized Pressure Agrobacterium Infiltration Device (SPAID) provides a means to deliver consistent amounts of bacterial suspensions into plant tissues with the goal of increasing reproducibility between replicates and laboratories.

  5. Abdul Kadir FA, Azizan KA, Othman R
    BMC Res Notes, 2021 Mar 25;14(1):117.
    PMID: 33766087 DOI: 10.1186/s13104-021-05532-9
    OBJECTIVES: Agarwood is the aromatic heartwood formed upon wounding of Aquilaria trees either naturally formed due to physical wound sustained from natural phenomena followed by microbial infection, or artificially induced using different inoculation methods. Different induction methods produce agarwoods with different aromas which have impacts on their commercial values. In lieu of elucidating the molecular mechanisms of agarwood formation under different treatment conditions, the transcriptome profiles of trunk tissues from healthy A. malaccensis tree, and naturally and artificially induced trees were obtained.

    DATA DESCRIPTION: The transcriptome of trunk tissues from healthy A. malaccensis, and naturally and artificially induced trees were sequenced using Illumina HiSeq™ 4000 platform which resulted in a total of 38.4 Gb clean reads with Q30 rate of at least 91%. The transcriptome consists of 85,986 unigenes containing 1305 bases on average which were annotated against several databases. From this, 44,654 unigenes were mapped to 290 metabolic pathways in the Kyoto Encyclopedia of Genes and Genomes database. These transcriptome data represent considerable contribution towards Aquilaria transcriptome data and enhance current knowledge in comprehending the molecular mechanisms underlying agarwood formation in Aquilaria spp.

  6. Lai NM, Teng CL, Lee ML
    BMC Res Notes, 2010;3:279.
    PMID: 21050429 DOI: 10.1186/1756-0500-3-279
    Despite a recent increase in activities to promote evidence-based practice (EBP), it was unclear how Malaysian hospital practitioners received this new approach in medicine. This study examines their confidence and perceptions on EBP.
  7. Kee QT, Abd Rahman MH, Mohamad Fadzil N, Mohammed Z, Shahar S
    BMC Res Notes, 2021 Oct 24;14(1):395.
    PMID: 34689826 DOI: 10.1186/s13104-021-05813-3
    OBJECTIVE: Near visual impairment (VI) is a common disability in an aging population. Near vision is crucial in activity of daily living including reading, smartphone and computer use and meal preparation. This study was conducted to determine the association between near visual acuity (VA) and contrast sensitivity (CS) with activity of daily living (ADL) among visually impaired older adults.

    RESULTS: A total of 208 participants aged  ≥  60 were recruited from the population-based longitudinal study on neuroprotective model for healthy longevity. Habitual near VA and CS were measured using Lighthouse near VA chart and Pelli-Robson CS chart, respectively. Lawton instrumental activities of daily living (IADL) was used to assess ADL. There are 41.8% participants with near visual impairment and 28.7% among them had IADL disability. Independent t test showed significant lower mean IADL score among visually impaired participants [t(206)  =  2.03, p  =  0.04]. IADL score significantly correlated with near VA (r  =   - 0.21, p  =  0.05) but not with CS (r  =   - 0.14, p = 0.21). Near VA (B  =   - 0.44, p  =  0.03) and age (B  =   - 0.07, p  =  0.01) significantly predicted IADL. The findings show poorer VA renders higher IADL disability, which may necessitate interventions to improve ADL among visually impaired older adults.

  8. Halim-Fikri H, Etemad A, Abdul Latif AZ, Merican AF, Baig AA, Annuar AA, et al.
    BMC Res Notes, 2015;8:176.
    PMID: 25925844 DOI: 10.1186/s13104-015-1123-y
    The Malaysian Node of the Human Variome Project (MyHVP) is one of the eighteen official Human Variome Project (HVP) country-specific nodes. Since its inception in 9(th) October 2010, MyHVP has attracted the significant number of Malaysian clinicians and researchers to participate and contribute their data to this project. MyHVP also act as the center of coordination for genotypic and phenotypic variation studies of the Malaysian population. A specialized database was developed to store and manage the data based on genetic variations which also associated with health and disease of Malaysian ethnic groups. This ethnic-specific database is called the Malaysian Node of the Human Variome Project database (MyHVPDb).
  9. Huda N, Ullah S, Wahab RA, Lani MN, Daud NHA, Shariff AHM, et al.
    BMC Res Notes, 2023 Sep 12;16(1):211.
    PMID: 37700361 DOI: 10.1186/s13104-023-06495-9
    OBJECTIVES: Pollen is a useful tool for identifying the provenance and complex ecosystems surrounding honey production in Malaysian forests. As native key pollinators in Malaysia, Apis dorsata and Heterotrigona itama forage on various plant/pollen species to collect honey. This study aims to generate a dataset that uncovers the presence of these plant/pollen species and their relative abundance in the honey of A. dorsata and H. itama. The information gathered from this study can be used to determine the geographical and botanical origin and authenticity of the honey produced by these two species.

    RESULTS: Sequence data were obtained for both A. dorsata and H. itama. The raw sequence data for A. dorsata was 5 Mb, which was assembled into 5 contigs with a size of 6,098,728 bp, an N50 of 15,534, and a GC average of 57.42. Similarly, the raw sequence data for H. itama was 6.3 Mb, which was assembled into 11 contigs with a size of 7,642,048 bp, an N50 of 17,180, and a GC average of 55.38. In the honey sample of A. dorsata, we identified five different plant/pollen species, with only one of the five species exhibiting a relative abundance of less than 1%. For H. itama, we identified seven different plant/pollen species, with only three of the species exhibiting a relative abundance of less than 1%. All of the identified plant species were native to Peninsular Malaysia, especially the East Coast area of Terengganu.

    DATA DESCRIPTION: Our data offers valuable insights into honey's geographical and botanical origin and authenticity. Metagenomic studies could help identify the plant species that honeybees forage and provide preliminary data for researchers studying the biological development of A. dorsata and H. itama. The identification of various flowers from the eDNA of honey that are known for their medicinal properties could aid in regional honey with accurate product origin labeling, which is crucial for guaranteeing product authenticity to consumers.

  10. Kew S
    BMC Res Notes, 2010 Dec 20;3:342.
    PMID: 21172018 DOI: 10.1186/1756-0500-3-342
    BACKGROUND: The ubiquitous use of mobile phones in sending and receiving text messages has become a norm for young people. Undeniably, text messaging has become a new and important communication medium not only in the social realm but in education as well. The aim of this study is to evaluate the effectiveness of using text messaging as a means to collect data for a medical research project.A cross sectional study was carried out during a double blind, randomized controlled trial to assess the efficacy and safety of a probiotic in the management of Irritable Bowel Syndrome (IBS). The study aim was to assess the response rate of weekly symptom reports via Short Message Service (SMS). The subjects were undergraduates in a private medical university in Malaysia. They were identified through a previous university wide study as suffering from IBS based on Rome III criteria. The subjects were randomly assigned to either the treatment arm receiving a daily probiotic, or the placebo arm. They were required to score their symptoms using eight-item-questionnaires at baseline, and thereafter weekly, for a total of 8 weeks. All subjects were given the choice to communicate their symptom scores by text messaging via mobile phones or by email. SMS text messages were sent to remind trial subjects to attend face-to-face visits and to complete a paper based 34-item-questionnaires on IBS quality of life assessment at baseline and at end of 8 weeks.

    FINDINGS: The response rate of weekly symptom scores via Short Message Service (SMS) from a total of 38 subjects was 100%. Through the study, 342 reports were submitted: 33.3% of these were received on the due date without reminder, 60.0% one day after the deadline, after a single reminder, 6.1% 2-3 days after the deadline, after 2-3 reminders and 0.6% 5 days after the deadline, after SMS, phone reminder and face-to-face encounter. All SMS symptom reports, whether on time or late, were complete. With the help of SMS reminder, all trial subjects completed the paper based IBS quality of life assessment at baseline and at end of study.

    CONCLUSIONS: This study found using text messaging via mobile phone an excellent instrument for collecting weekly symptom reports in response to trial medication, reminding trial subjects to attend face to face visits and completing more complex paper based evaluation. The 100% response rate of weekly symptom reports was facilitated by using simple number codes for SMS submission.

    TRIAL REGISTRATION: Not appropriate.

  11. Fong SW, Few LL, See Too WC, Khoo BY, Nik Ibrahim NN, Yahaya SA, et al.
    BMC Res Notes, 2015;8:679.
    PMID: 26576922 DOI: 10.1186/s13104-015-1677-8
    Biomarkers play a pivotal role in the diagnosis and management of patients with acute coronary syndrome. This study aimed to investigate the differences in level of several biomarkers, i.e. C-reactive protein, myeloperoxidase, soluble CD40 ligand and placental growth factor, between acute coronary syndrome and chronic stable angina patients. The relationship between these biomarkers in the coronary circulation and systemic circulation was also investigated.
  12. Lian BSX, Yek AEH, Shuvas H, Abdul Rahman SF, Muniandy K, Mohana-Kumaran N
    BMC Res Notes, 2018 Mar 27;11(1):197.
    PMID: 29580266 DOI: 10.1186/s13104-018-3302-0
    OBJECTIVE: There are number of studies which report that BCL-2 anti-apoptotic proteins (e.g. BCL-2, BCL-XL, and MCL-1) are highly expressed in cervical cancer tissues compared to the normal cervical epithelia. Despite these reports, targeting these proteins for cervical cancer treatment has not been explored extensively. BH3-mimetics that inhibit specific BCL-2 anti-apoptotic proteins may hold encouraging treatment outcomes for cervical cancer management. Hence, the aim of this pilot study is to investigate the sensitivity of cervical cancer cell lines to combination of two BH3-mimetics namely ABT-263 which selectively inhibits BCL-2, BCL-XL and BCL-w and A-1210477, a selective MCL-1 inhibitor.

    RESULTS: We report that combination of A-1210477 and ABT-263 exhibited synergistic effects on all cervical cancer cell lines tested. Drug sensitization studies revealed that A-1210477 sensitised the cervical cancer cell lines SiHa and CaSki to ABT-263 by 11- and fivefold, respectively. Sensitization also occurred in the opposite direction whereby ABT-263 sensitised SiHa and CaSki to A-1210477 by eightfold. This report shows that combination of ABT-263 and A-1210477 could be a potential treatment strategy for cervical cancer. Extensive drug mechanistic studies and drug sensitivity studies in physiological models are necessary to unleash the prospect of this combination for cervical cancer therapy.

  13. Teh JL, Abdul Rahman SF, Domnic G, Satiyasilan L, Chear NJY, Singh D, et al.
    BMC Res Notes, 2021 Aug 13;14(1):310.
    PMID: 34389056 DOI: 10.1186/s13104-021-05727-0
    OBJECTIVE: The spheroid model provides a physiological platform to study cancer cell biology and drug sensitivity. Usage of bovine collagen I for spheroid assays is costly especially when experiments are conducted in 24-well plates, as high volume of bovine collagen I is needed. The aim of the study was to downsize spheroid assays to a microfluidic 3D cell culture chip and compare the growth, invasion and response to drug/compound of spheroids embedded in the 3D chip to spheroids embedded in 24-well plates.

    RESULTS: Spheroids generated from nasopharyngeal carcinoma cell line HK-1 continuously grew and invaded into collagen matrix in a 24-well plate. Similar observations were noticed with spheroids embedded in the 3D chip. Large spheroids in both 24-well plate and the 3D chip disintegrated and invaded into the collagen matrix. Preliminary drug sensitivity assays showed that the growth and invasion of spheroids were inhibited when spheroids were treated with combination of cisplatin and paynantheine at high concentrations, in a 24-well plate. Comparable findings were obtained when spheroids were treated with the same drug combination in the 3D chip. Moving forward, spheroid assays could be performed in the 3D chip in a more high-throughput manner with minimal time and cost.

  14. Tan ACC, Leong EWK, Chua AC, Moy FM
    BMC Res Notes, 2013;6:173.
    PMID: 23634656 DOI: 10.1186/1756-0500-6-173
    BACKGROUND: Variations in racial haemoglobin had been previously described in multiple studies locally and abroad. This study was conducted to quantify the differences in haemoglobin of booking primigravidae amongst the three major races in Malaysia at the antenatal clinic of University Malaya Medical Centre, Kuala Lumpur.
    FINDINGS: One year prospective study of booking full blood count sample of primigravidae taken in one centre was conducted. Multiple comparative analyses of the booking haemoglobin were performed using the One-way ANOVA comparative mean test in each trimester. 622 primigravidae without any known history of haematological disorders were recruited into the study. The mean haemoglobin for the Indian race was the lowest compared to the two other races in the second and the third trimesters, and it was found to be statistically significant lower (p- value 0.001) than the Malay race in the second trimester. It was also found that the Indian race had a significantly higher incidence of moderate to severe anaemia (p- value: 0.029). The prevalence of anaemia in our study population is also significantly higher in the Indian population (p- value: 0.01 ).
    CONCLUSIONS: The findings from this study have established that there is racial preponderance to anaemia in pregnancy. The Indian race is at a higher risk of having anaemia in pregnancy particularly in the second trimester.
    Study site: Antenatal clinic, University Malaya Medical Centre (UMMC), Kuala Lumpur, Malaysia
  15. Wong MY, Govender NT, Ong CS
    BMC Res Notes, 2019 Sep 24;12(1):631.
    PMID: 31551084 DOI: 10.1186/s13104-019-4652-y
    OBJECTIVE: Basal stem rot disease causes severe economic losses to oil palm production in South-east Asia and little is known on the pathogenicity of the pathogen, the basidiomyceteous Ganoderma boninense. Our data presented here aims to identify both the house-keeping and pathogenicity genes of G. boninense using Illumina sequencing reads.

    DESCRIPTION: The hemibiotroph G. boninense establishes via root contact during early stage of colonization and subsequently kills the host tissue as the disease progresses. Information on the pathogenicity factors/genes that causes BSR remain poorly understood. In addition, the molecular expressions corresponding to G. boninense growth and pathogenicity are not reported. Here, six transcriptome datasets of G. boninense from two contrasting conditions (three biological replicates per condition) are presented. The first datasets, collected from a 7-day-old axenic condition provide an insight onto genes responsible for sustenance, growth and development of G. boninense while datasets of the infecting G. boninense collected from oil palm-G. boninense pathosystem (in planta condition) at 1 month post-inoculation offer a comprehensive avenue to understand G. boninense pathogenesis and infection especially in regard to molecular mechanisms and pathways. Raw sequences deposited in Sequence Read Archive (SRA) are available at NCBI SRA portal with PRJNA514399, bioproject ID.

  16. Chow KS, Ghazali AK, Hoh CC, Mohd-Zainuddin Z
    BMC Res Notes, 2014 Feb 01;7:69.
    PMID: 24484543 DOI: 10.1186/1756-0500-7-69
    BACKGROUND: One of the concerns of assembling de novo transcriptomes is determining the amount of read sequences required to ensure a comprehensive coverage of genes expressed in a particular sample. In this report, we describe the use of Illumina paired-end RNA-Seq (PE RNA-Seq) reads from Hevea brasiliensis (rubber tree) bark to devise a transcript mapping approach for the estimation of the read amount needed for deep transcriptome coverage.

    FINDINGS: We optimized the assembly of a Hevea bark transcriptome based on 16 Gb Illumina PE RNA-Seq reads using the Oases assembler across a range of k-mer sizes. We then assessed assembly quality based on transcript N50 length and transcript mapping statistics in relation to (a) known Hevea cDNAs with complete open reading frames, (b) a set of core eukaryotic genes and (c) Hevea genome scaffolds. This was followed by a systematic transcript mapping process where sub-assemblies from a series of incremental amounts of bark transcripts were aligned to transcripts from the entire bark transcriptome assembly. The exercise served to relate read amounts to the degree of transcript mapping level, the latter being an indicator of the coverage of gene transcripts expressed in the sample. As read amounts or datasize increased toward 16 Gb, the number of transcripts mapped to the entire bark assembly approached saturation. A colour matrix was subsequently generated to illustrate sequencing depth requirement in relation to the degree of coverage of total sample transcripts.

    CONCLUSIONS: We devised a procedure, the "transcript mapping saturation test", to estimate the amount of RNA-Seq reads needed for deep coverage of transcriptomes. For Hevea de novo assembly, we propose generating between 5-8 Gb reads, whereby around 90% transcript coverage could be achieved with optimized k-mers and transcript N50 length. The principle behind this methodology may also be applied to other non-model plants, or with reads from other second generation sequencing platforms.

  17. Ee Uli J, Yong CS, Yeap SK, Alitheen NB, Rovie-Ryan JJ, Mat Isa N, et al.
    BMC Res Notes, 2018 Dec 22;11(1):923.
    PMID: 30577850 DOI: 10.1186/s13104-018-4014-1
    OBJECTIVE: Using high-throughput RNA sequencing technology, this study aimed to sequence the transcriptome of kidney and liver tissues harvested from Peninsular Malaysia cynomolgus macaque (Macaca fascicularis). M. fascicularis are significant nonhuman primate models in the biomedical field, owing to the macaque's biological similarities with humans. The additional transcriptomic dataset will supplement the previously described Peninsular Malaysia M. fascicularis transcriptomes obtained in a past endeavour.

    RESULTS: A total of 75,350,240 sequence reads were obtained via Hi-seq 2500 sequencing technology. A total of 5473 significant differentially expressed genes were called. Gene ontology functional categorisation showed that cellular process, catalytic activity, and cell part categories had the highest number of expressed genes, while the metabolic pathways category possessed the highest number of expressed genes in the KEGG pathway analysis. The additional sequence dataset will further enrich existing M. fascicularis transcriptome assemblies, and provide a dataset for further downstream studies.

  18. Sugawara D, Gu Y, Masuyama A, Ng SL, Phoo EYM, Raja Reza Shah RIAB, et al.
    BMC Res Notes, 2021 Nov 04;14(1):409.
    PMID: 34736522 DOI: 10.1186/s13104-021-05819-x
    OBJECTIVES: The COVID-19 pandemic has impacted the mental health of people worldwide. Psychological resilience has been shown to buffer against the threat of the pandemic (i.e., COVID-19 fear) and sustain mental health. The extent to which psychological resilience factors impact mental health maintenance, however, is unclear, given broad differences in infection rates, prevention approaches, government interventions across different cultures and contexts. Our study examines resilience factors and how they protect individuals from COVID-19-related fear and sustain their mental health.

    DATA DESCRIPTION: Data were collected from 1583 (Mage = 32.22, SD = 12.90, Range = 19-82) respondents from Japan, China, the United States, and Malaysia between October to November 2020. We collected data across age and sex, marital status, number of children, and occupations. We also accounted for stay-at-home measures, change in income, COVID-19 infection status, place of residence, and subjective social status in the study. Our variables included mental health-related and resilience constructs, namely (i) fear of COVID-19, (ii) depression, anxiety, and stress; (iii) present, past, and future life satisfaction, (iv) sense of control, (v) positive emotions, (vi) ego-resilience, (vii) grit, (viii) self-compassion, (ix) passion, and (x) relational mobility. All questionnaires were assessed for their suitability across the four countries with the necessary translation checks. Results from this study can be instrumental in examining the impact of multiple resilience factors and their interaction with demographic variables in shaping mental health outcomes.

  19. Siti-Azrin AH, Norsa'adah B, Naing NN
    BMC Res Notes, 2017 Dec 06;10(1):705.
    PMID: 29212521 DOI: 10.1186/s13104-017-2990-1
    BACKGROUND: Nasopharyngeal carcinoma (NPC) exhibits a distinctive racial and geographic distribution. Many studies have reported varied significant prognostic factors affect the survival of NPC patients. Hence, this current study aimed to identify the prognostic factors of NPC patients registered in a tertiary referral hospital.

    METHODS: The records of one hundred and thirty-four NPC cases confirmed by histopathology in Hospital Universiti Sains Malaysia (USM) between 1st January 1998 and 31st December 2007 that fulfilled the inclusion and exclusion criteria were retrospectively reviewed. Simple and multiple Cox proportional hazard regression analyses were performed to determine the significant prognostic factors affect the survival of NPC patients.

    RESULTS: The mean (SD) age of patients diagnosed with NPC was 48.12 (15.88) years with Malay was the largest ethnic group compared to other ethnicities. Most of patients had locally advanced stage IV (40.6%) and stage III (39.1%) of NPC. The overall median survival time of NPC patients was 31.30 months (95% CI 23.76, 38.84). The significant prognostic factors that influenced the survival of NPC patients were older age (HR 1.03, 95% CI 1.01, 1.04), metastases (HR 2.52, 95% CI 1.01, 6.28) and stage IV disease (HR 4.50, 95% CI 1.66, 9.88).

    CONCLUSION: Older age, the presence of metastases and late stage are significant prognostic factors that influence the survival of NPC. Therefore, it is important to provide education to public and to raise awareness to diagnose NPC at an earlier stage and before the presence of metastases.

  20. Ovesen C, Jakobsen JC, Gluud C, Steiner T, Law Z, Flaherty K, et al.
    BMC Res Notes, 2018 Jun 13;11(1):379.
    PMID: 29895329 DOI: 10.1186/s13104-018-3481-8
    OBJECTIVE: We present the statistical analysis plan of a prespecified Tranexamic Acid for Hyperacute Primary Intracerebral Haemorrhage (TICH)-2 sub-study aiming to investigate, if tranexamic acid has a different effect in intracerebral haemorrhage patients with the spot sign on admission compared to spot sign negative patients. The TICH-2 trial recruited above 2000 participants with intracerebral haemorrhage arriving in hospital within 8 h after symptom onset. They were included irrespective of radiological signs of on-going haematoma expansion. Participants were randomised to tranexamic acid versus matching placebo. In this subgroup analysis, we will include all participants in TICH-2 with a computed tomography angiography on admission allowing adjudication of the participants' spot sign status.

    RESULTS: Primary outcome will be the ability of tranexamic acid to limit absolute haematoma volume on computed tomography at 24 h (± 12 h) after randomisation among spot sign positive and spot sign negative participants, respectively. Within all outcome measures, the effect of tranexamic acid in spot sign positive/negative participants will be compared using tests of interaction. This sub-study will investigate the important clinical hypothesis that spot sign positive patients might benefit more from administration of tranexamic acid compared to spot sign negative patients. Trial registration ISRCTN93732214 ( http://www.isrctn.com ).

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