HALT-IT - tranexamic acid for the treatment of gastrointestinal bleeding: study protocol for a randomised controlled trial

Roberts, IORCID logo, Coats, T, Edwards, PORCID logo, Gilmore, I, Jairath, V, Ker, KORCID logo, Manno, DORCID logo, Shakur, HORCID logo, Stanworth, S and Veitch, A (2014). HALT-IT - tranexamic acid for the treatment of gastrointestinal bleeding: study protocol for a randomised controlled trial. [Dataset]. London School of Hygiene & Tropical Medicine, London, United Kingdom. 10.17037/DATA.89.
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Documentation associated with the HALT-IT trial, a pragmatic, randomised, double-blind, placebo-controlled trial which will determine the effect of tranexamic acid on mortality, morbidity (re-bleeding, non-fatal vascular events), blood transfusion, surgical intervention, and health status in patients with acute gastrointestinal bleeding.

Keywords

Gastrointestinal bleeding, Tranexamic acid, Clinical trials

File1-StudyEntryForm.pdf
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Study Instrument
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Entry form used to assess eligibility and collect baseline information for the study
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File2-OutcomeForm.pdf
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Short Outcome form to be completed from medical records within 28 days after randomisation, on discharge from randomising hospital, or on death (whichever occurs first)
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File3-SummarySheet.pdf
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Short information leaflet on the trial provided to the patient and, if present, their relatives, prior to enrolment
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File4-InformationSheet.pdf
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Trial information sheet to be provided to the patient
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File5-ConsentForm.pdf
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Consent sheet. If the patient cannot read or write, the information sheet may be read to them and they may mark the form with a cross or thumbprint. Witnesses not associated with the trial must provide a full signature confirming the mark
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UserGuide.pdf
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Documentation
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User guide for data collection
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