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dc.contributor.authorBrenner, Aen_US
dc.contributor.authorAfolabi, Aen_US
dc.contributor.authorAhmad, SMen_US
dc.contributor.authorArribas, Men_US
dc.contributor.authorChaudhri, Ren_US
dc.contributor.authorCoats, Ten_US
dc.contributor.authorCuzick, Jen_US
dc.contributor.authorGilmore, Ien_US
dc.contributor.authorHawkey, Cen_US
dc.contributor.authorJairath, Ven_US
dc.contributor.authorJavaid, Ken_US
dc.contributor.authorKayani, Aen_US
dc.contributor.authorMutti, Men_US
dc.contributor.authorNadeem, MAen_US
dc.contributor.authorShakur-Still, Hen_US
dc.contributor.authorStanworth, Sen_US
dc.contributor.authorVeitch, Aen_US
dc.contributor.authorRoberts, Ien_US
dc.contributor.authorHALT-IT Trial Collaboratorsen_US
dc.date.accessioned2019-09-18T14:01:58Z
dc.date.available2019-07-08en_US
dc.date.issued2019-07-30en_US
dc.identifier.other467
dc.identifier.urihttps://qmro.qmul.ac.uk/xmlui/handle/123456789/59722
dc.description.abstractBACKGROUND: Acute gastrointestinal (GI) bleeding is an important cause of mortality worldwide. Bleeding can occur from the upper or lower GI tract, with upper GI bleeding accounting for most cases. The main causes include peptic ulcer/erosive mucosal disease, oesophageal varices and malignancy. The case fatality rate is around 10% for upper GI bleeding and 3% for lower GI bleeding. Rebleeding affects 5-40% of patients and is associated with a four-fold increased risk of death. Tranexamic acid (TXA) decreases bleeding and the need for blood transfusion in surgery and reduces death due to bleeding in patients with trauma and postpartum haemorrhage. It reduces bleeding by inhibiting the breakdown of fibrin clots by plasmin. Due to the methodological weaknesses and small size of the existing trials, the effectiveness and safety of TXA in GI bleeding is uncertain. The Haemorrhage ALleviation with Tranexamic acid - Intestinal system (HALT-IT) trial aims to provide reliable evidence about the effects of TXA in acute upper and lower GI bleeding. METHODS: The HALT-IT trial is an international, randomised, double-blind, placebo-controlled trial of tranexamic acid in 12,000 adults (increased from 8000) with acute upper or lower GI bleeding. Eligible patients are randomly allocated to receive TXA (1-g loading dose followed by 3-g maintenance dose over 24 h) or matching placebo. The main analysis will compare those randomised to TXA with those randomised to placebo on an intention-to-treat basis, presenting the results as effect estimates (relative risks) and confidence intervals. The primary outcome is death due to bleeding within 5 days of randomisation and secondary outcomes are: rebleeding; all-cause and cause-specific mortality; thromboembolic events; complications; endoscopic, radiological and surgical interventions; blood transfusion requirements; disability (defined by a measure of patient's self-care capacity); and number of days spent in intensive care or high-dependency units. Subgroup analyses for the primary outcome will consider time to treatment, location of bleeding, cause of bleed and clinical Rockall score. DISCUSSION: We present the statistical analysis of the HALT-IT trial. This plan was published before the treatment allocation was unblinded. TRIAL REGISTRATION: Current Controlled Trials, ID: ISRCTN11225767. Registered on 3 July 2012; Clinicaltrials.gov, ID: NCT01658124. Registered on 26 July 2012.en_US
dc.format.extent467 - ?en_US
dc.languageengen_US
dc.relation.ispartofTrialsen_US
dc.rightsThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
dc.subjectClinical trialen_US
dc.subjectGastrointestinal haemorrhageen_US
dc.subjectStatistical analysisen_US
dc.subjectTranexamic aciden_US
dc.subjectAntifibrinolytic Agentsen_US
dc.subjectData Interpretation, Statisticalen_US
dc.subjectDouble-Blind Methoden_US
dc.subjectGastrointestinal Hemorrhageen_US
dc.subjectHumansen_US
dc.subjectMulticenter Studies as Topicen_US
dc.subjectRandomized Controlled Trials as Topicen_US
dc.subjectTranexamic Aciden_US
dc.subjectTreatment Outcomeen_US
dc.titleTranexamic acid for acute gastrointestinal bleeding (the HALT-IT trial): statistical analysis plan for an international, randomised, double-blind, placebo-controlled trial.en_US
dc.typeArticle
dc.rights.holder© The Author(s). 2019
dc.identifier.doi10.1186/s13063-019-3561-7en_US
pubs.author-urlhttps://www.ncbi.nlm.nih.gov/pubmed/31362765en_US
pubs.issue1en_US
pubs.notesNot knownen_US
pubs.publication-statusPublished onlineen_US
pubs.volume20en_US
dcterms.dateAccepted2019-07-08en_US
rioxxterms.funderDefault funderen_US
rioxxterms.identifier.projectDefault projecten_US


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