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And i am the trial manager for the calibre trial at bctu. 4 the chief investigator is professor dhiraj tripathi. 15 i will provide some background information to the trial, 19 the objectives of the trial, details of the study design, 20 information on data handling, and pharmacovigilance. 21 liver cirrhosis is the fifth largest cause of death 22 due to the need for

Hospitalisation and time off work. 26 variceal bleeding has a one-year mortality of up to 40%. 29 there is disparity in the current uk guidelines. 32 and bsg guidelines recommend non-selective beta blockers. 34 is to compare carvedilol and variceal band ligation 40 the development of other complications of cirrhosis, 46 the cost effectiveness of treatments will also be

Compared 48 and the use of alternative or cross-over therapies. 50 the study is a randomised control parallel group trial. 51 participants will remain in the trial for 12 months. 58 this would equate to one patient per month per open site 64 to either variceal band ligation or to receive carvedilol. 72 to ascertain if there have been any adverse events. 75 at six months

And 12 months in line with standard of care. 77 the inclusion criteria is any patient with liver cirrhosis 78 as defined in the bsg guidelines that have never bled. 82 the exclusion criteria is anyone under the age of 18; 83 or contraindication to beta blockers including asthma; 85 acute alcoholic hepatitis at the time of randomization; 86 a current or past history of

Non-selective beta blocker use, 92 or radiological port-systemic shunts such as tipss. 96 only participants who have not yet started treatment 104 shows the consent process during a planned endoscopy 107 if the patient decides not to take part in the trial, 119 if the patient decides to take part in the calibre trial, 122 if the patient is found to have medium to large

Varices, 125 if the patient is found to have small or no varices, 129 figure two shows the scheme on page 33 of the protocol 132 so, the patient has confirmed medium to large varices 136 as soon as possible thereafter, preferably within two weeks. 141 figure three shows the scheme on page 34 of the protocol 152 and the patient will be randomised to the calibre trial 166

Which is version 4.0 dated the 7th of september, 2021, 171 initialling all boxes if the visit is face-to-face. 172 the research staff will complete the informed consent form 174 the form will also be signed and dated by a witness. 177 and a copy will be kept in the participant’s medical notes. 182 unique usernames and passwords will be provided. 188 the calibre trials team

Are available monday to friday 190 but can be restarted once the information is available. 200 the crfs should be completed at the face-to-face visit only. 219 for participants randomised to the variceal banding arm, 220 usually two to four weekly until the varices are eradicated. 222 if 12.5 mg once a day is not tolerated by the participant, 234 and no additional blood

Tests will be required. 244 is any variceal bleed within one year of randomization. 250 liver-related mortality; and cardiovascular mortality. 255 and transplant free survival at one year from randomization. 256 the use of alternative therapies and cross-over therapies. 263 there are a number of different patient withdrawals 264 from total withdrawal to withdrawal from trial

Treatment 265 due to significant non-compliance with the protocol. 271 standard of care laboratory results; clinical event data; 276 health economics data; recruitment; and any withdrawals. 277 the original or a copy of the crfs should be sent to bctu, 286 staff at bctu will transcribe the data from the paper crfs 294 site staff will not be able to amend the crf online 296

This includes physical security measures and access control. 300 which does not necessarily have a causal relationship 306 is any untoward and unintended response in a subject 309 which is related to any dose administered to that subject. 311 of which is not consistent with the information in question 314 adverse reaction, or unexpected adverse reaction 318 or consists of

A congenital abnormality or birth defect. 324 they are recognised complications of liver cirrhosis 326 please contact the calibre trials office for advice. 331 within 24 hours of the site being made aware of the event. 347 and having them registered with the associate pi scheme. 354 the investigator site files should always be kept up-to-date 355 please keep consent forms,

Copies of paper crfs, sae forms, 358 these are the calibre trial team contact details 360

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agreedlmh 1080p By Lisa Holden CALIBRE