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RESCUE-ASDH Newsletter August 2015            @rescueasdh
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Newsletter August 2015


Updates on recruitment and trial related matters


Dear <<First Name>> <<Last Name>>

Thank you for your continuing support of the RESCUE-ASDH Trial!

We are approaching 12 months since recruitment started and the study has reached a number of important milestones:

  • 35 patients have been randomised from 12 UK sites 
  • 39 patients have been enrolled in the observational study cohort
  • 19 centres –each with a trainee co-PI- are now open to recruitment in the UK and 2 more in set up. 

We are also currently working on rolling out the RESCUE-ASDH Trial to several US level I trauma centres. For for more details on recruitment please scroll down to the "Recruitment Details"-section.

We have also redesigned our website.It will have regular news post, twitter feed and hosts all study related documents for sites and the web randomisation system (www.rescueasdh.org).


Many thanks to all PIs / trainee co-PIs / research staff for your ongoing efforts to randomise all eligible patients.


Best wishes,

RESUE-ASDH Trial Management Group

In this edition:

A Letter from  Professors Peter Hutchinson & Tony Bell

Upcoming Events 


Literature Highlights 

Protocol Changes 

 Randomisation Details 

Recruitment Details 


We would like to welcome Gareth Roberts (PI), Jane Halliday (Co-PI) and their Research Team at Preston to the RESCUE-ASDH study and wish them good luck with recruitment!
Congratulations to Christos Tolias (PI) and Bhaskar Thakur (Co-PI) and their team at Kings College London for randomising their first participant!
A Letter from Professors
Peter Hutchinson &Tony Bell


Dear Colleagues,
 
Many thanks for your support with the RESCUE-ASDH study. As you can see from the attached recruitment graph, overall, the study is progressing well. We have 35 patients in the randomised arm and 39 patients in the observation arm. The Steering Committee discussed ways to provide a more reproducible allocation of patients between these two arms of the study.
 
The observation arm includes patients in whom a craniectomy was either performed or withheld on clinical grounds. Where patients are thought to have a clinical indication to undergo craniectomy, it was clear that they should undergo the procedure.  However, where there is no clear clinical indication for craniectomy, the risks of late intracranial hypertension are difficult to predict, and the available data do not provide us with information on which to base a decision.  In this context, we felt that the rational and ethical decision, in most cases, would be to randomize the patient, rather than allocate them to the observational arm.
 
The study will be best placed to define the benefit of decompressive craniectomy if we can maximise the number of patients randomised compared to the observation arm. While we appreciate there are certain patients who cannot be randomised, allocation of most other patients to the randomised arm would seem to be the most ethical option, will assist in completing the study sooner, facilitate the data analysis, and add to the strength of the results.
 
With best wishes,
 
Prof Peter Hutchinson, Chief Investigator
 
Prof Tony Bell Chief, Independent Chair of the Trial Steering Committee





Prof. Peter Hutchinson
email: ci [at] rescueasdh.org

Prof. Tony Bell
email: tsc [at] rescueasdh.org

Upcoming Events


The study will be presented at the following conferences:

  • Society of British Neurological Surgeons Autumn Meeting, 9-11 September 2016, York, UK
  • 15th Interim Meeting of the World Federation of Neurosurgical Societies, 8-12 September 2016, Rome, Italy 
  • 9th European Congress of Emergency Medicine, October 2015, Torino, Italy
Literature Highlights

The guidelines for the surgical management of Traumatic Brain Injury were published under the auspices of the American Association of Neurological Surgeons, the Congress of Neurological Surgeons, the European Brain Injury Consortium, the American College of Surgeons and the World Federation of Neurosurgical Societies in 2006. They can be accessed online here. Following a systematic literature review, the authors noted that "some centers treat all ASDH with decompressive craniectomies, whereas other centers used solely craniotomies". Importantly, they concluded that craniotomy versus decompressive craniectomy for the initial evacuation of ASDH is a key issue for future investigation

Protocol Amended - Version 2.0 Now Approved

  • 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.

  • Major Changes:

    • Consent process has changed

      • The "Independent Healthcare Professional (IHP) Enrolment" form has been replaced by the "Treating Surgeon Declaration"-form

      • Now it's not mandatory to have an IHP to countersign the enrolment form (i.e. if there is none available).

    • Exclusion criteria have changed

      • "Bilateral unresponsive dilated pupils of ≥5mm and/or brainstem injuries on CT" has been REMOVED

      • "Uncorrected coagulopathy" has been REMOVED

  • 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 

RANDOMISATION PROCESS
 
To not miss any eligible participant from being randomised, there are 3 different ways of randomisation in this trial:
  • For web based randomisation:   www.rescueasdh.org (enter username & password)
  • For phone based randomisation:  0800 2802 307 (enter site ID code)
  • Any questions about randomisation including patient eligibility, please contact our team: 01223 746452 (24/7)

Recruitment Details

  • We only have 7 months left of the pilot phase in which we need to reach the target of 120 randomised patients.
  • Randomised: 35 patients
  • Observational cohort: 39 patients
  • RESCUE-ASDH monthly recruitment rates shown below:
Total recruitment by centre:
 
  Randomised Observational
Cambridge 10 9
Southampton 4 8
Liverpool 4 6
Bristol 3 5
King’s College Hospital, London 2 4
Plymouth 2 2
Bart's (Royal London) 2 0
Middleborough 2 0
Leeds 2 0
Nottingham 2 0
St George's Hospital, London 1 1
Sheffield 1 0
Birmingham 0 3
St Mary's Hospital, London 0 1
Newcastle 0 0
Preston 0 0
Manchester 0 0
Cardiff 0 0
Coventry 0 0
Oxford 0 0
Brighton 0 0
Total 35 39
@rescueasdh   www.rescueasdh.org   info@rescueasdh.org
Copyright © *|CURRENT_YEAR|* RESCUE-ASDH, All rights reserved.

Our mailing address is: 
RESCUE-ASDH
Box 167, Division of Neurosurgery, University of Cambridge, Cambridge Biomedical Campus
Addenbrooke's Hospital
Cambridge, Cambridgeshire CB2 0QQ
United Kingdom

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