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- The aim of this protocol amendment is fivefold; first to capture participant co-morbidity using the Clinical Frailty Score (CFS), second to measure post stroke fatigue using Fatigue Severity Scale (FSS-7), third to streamline the health economics/resource use form to improve data completion for patients, fourth to add an eligibility checklist to facilitate enrolment out of hours and finally we also took this opportunity to make some minor text changes to the protocol, including updating the literature review and adding points of clarity to assist investigators.
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- The key contact for the University of Nottingham Sponsor is being amended from Ms Angela Shone to Mr Ali Alshukry. The sponsor details will be updated in the TICH-3 protocol when we next submit a protocol amendment. Please continue to use TICH-3 Protocol Final v2.0 07.10.2022.
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- This substantial amendment comprises changes to the protocol. Primarily to include patients into the TICH-3 trial that have had an Intracranial haemorrhage (ICH) while on Direct Oral Anticoagulant (DOAC). This was supported by the findings from the TICH- NOAC trial undertaken by Prof Lyrer et al in Switzerland. Enabling this protocol amendment will allow prompt recruitment of patients to the trial that are on DOACs experiencing ICH.
- Other formatting changes and small clarifications have been made, full details can be viewed within the locked amendment tool document.
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