HALT-IT - tranexamic acid for the treatment of gastrointestinal bleeding: study protocol for a randomised controlled trial
Roberts, I; Coats, T; Edwards, P; Gilmore, I; Jairath, V; Ker, K; Manno, D; Shakur, H; 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.
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 trialsDocumentation
UserGuide.pdf
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subject - Documentation
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- Available under Creative Commons: Attribution 3.0
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info - User guide for data collection
picture_as_pdf - application/pdf
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- 420kB
Study Instrument
File1-StudyEntryForm.pdf
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subject - Study Instrument
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- Available under Creative Commons: Attribution 3.0
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info - Entry form used to assess eligibility and collect baseline information for the study
picture_as_pdf - application/pdf
- folder_info
- 490kB
File2-OutcomeForm.pdf
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subject - Study Instrument
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- Available under Creative Commons: Attribution 3.0
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info - 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)
picture_as_pdf - application/pdf
- folder_info
- 677kB
File3-SummarySheet.pdf
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subject - Study Instrument
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- Available under Creative Commons: Attribution 3.0
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info - Short information leaflet on the trial provided to the patient and, if present, their relatives, prior to enrolment
picture_as_pdf - application/pdf
- folder_info
- 274kB
File4-InformationSheet.pdf
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subject - Study Instrument
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- Available under Creative Commons: Attribution 3.0
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info - Trial information sheet to be provided to the patient
picture_as_pdf - application/pdf
- folder_info
- 299kB
File5-ConsentForm.pdf
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subject - Study Instrument
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- Available under Creative Commons: Attribution 3.0
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info - 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
picture_as_pdf - application/pdf
- folder_info
- 517kB
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