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Randomised Evaluation of Surgery with Craniectomy for patients Undergoing Evacuation of Acute Subdural Haematoma Contact: Arti Gulati Interim RESCUE-ASDH Trial Coordinator Email: arti.gulati@addenbrookes.nhs.uk ; info@rescueasdh.org ; website: www.rescueasdh.orgarti.gulati@addenbrookes.nhs.uk info@rescueasdh.orgwww.rescueasdh.org Issue 5, Aug 2015 19 study centres are now open in UK and 2 more in set up. We have so far enrolled 70 participants on to RESCUE ASDH study, out of which 32 are randomised and 38 observational. We only have 7 months left of the pilot phase in which we need to reach the target of 120 randomised patients. Please ensure that ALL eligible patients are screened and given the opportunity to be included in the trial. To not miss any eligible participant from being randomised, there are 3 different ways of randomisation in this trial: 1. For web based randomisation: www.rescueasdh.org Enter Site Username and password 2. For phone based randomisation: 0800 2802 307 & Enter Site ID code Please refer to trial flow chart poster and site initiation presentation slides for site details. 3. Any questions about randomisation including patient eligibility, please contact our study team 24x7: 01223 746452 To avoid protocol breaches and cross- over of patients: Please randomise patient in theatre after the ASDH has been evacuated and the surgeon has assessed the patient as eligible. Congratulations to Queens Medical Centre, Nottingham Kings College London for randomising their first participants! Welcome Gareth Roberts (PI) and Jane Halliday (Co- PI) and their Preston research team at Preston. This site is now open to recruitment!
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Randomised Evaluation of Surgery with Craniectomy for patients Undergoing Evacuation of Acute Subdural Haematoma Contact: Arti Gulati RESCUE-ASDH Trial Coordinator (in the interim) Email: arti.gulati@addenbrookes.nhs.uk ; info@rescueasdh.org ; website: www.rescueasdh.orgarti.gulati@addenbrookes.nhs.uk info@rescueasdh.orgwww.rescueasdh.org Issue 5, Aug 2015 Site Date opened R Cohort O Cohort CambridgeSep-1498 SouthamptonOct-1448 PlymouthDec-1422 LiverpoolOct-1434 LeedsNov-142 SheffieldDec-141 MiddlesbroughFeb-152 BirminghamMar-153 Royal LondonMar-152 St Mary’s London Mar-15 1 ManchesterMar-15 CoventryApr-15 CardiffMay-15 BristolMay-1535 NottinghamMay-152 St George’sMay-1511 NewcastleJun-15 King's College London Jun-1514 PrestonJul- 15 TOTAL 3238 Sites in Set up Sites initiated & awaiting R&D sign off Sites awaiting initiation visit OxfordBrighton
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Randomised Evaluation of Surgery with Craniectomy for patients Undergoing Evacuation of Acute Subdural Haematoma Contact: Arti Gulati RESCUE-ASDH Trial Coordinator (in the interim) Email: arti.gulati@addenbrookes.nhs.uk ; info@rescueasdh.org ; website: www.rescueasdh.orgarti.gulati@addenbrookes.nhs.uk info@rescueasdh.orgwww.rescueasdh.org Issue 5, Aug 2015 Substantial Amendment 1 Implementation of this amendment by a site should only occur after R&D approval and after receiving new versions of documents and confirmation from the coordinating team. New Documents all v2.0 08 June 2015: Protocol Participant information sheet Participant consent form Consultee Information Sheet Consultee Declaration Form New consent form: Treating Surgeon Declaration New CRFs Newly Designed Website We have redesigned our website: www.rescueasdh.org www.rescueasdh.org This website will soon be up and running. It will have regular news post, twitter feed and all study related documents for sites. All patient identifiable data should be sent to : RESCUEASDH.PID@nhs.net RESCUEASDH.PID@nhs.net Please return all completed CRFs promptly to the Trial Data Management team: CRF@RESCUEASDH.ORGCRF@RESCUEASDH.ORG Fax: +44 1223 596471
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