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RESCUE-ASDH Newsletter December 2015            @rescueasdh                    View this email in your browser

Newsletter December 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 now 13 months since recruitment started and the study has reached a number of important milestones:

  • 65 patients have been randomised from 15 UK sites 
  • 60 patients have been enrolled in the observational study cohort
  • 21 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 and Asian level I trauma centres. For for more details on recruitment please scroll down to the "Recruitment Details"-section.

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:

Upcoming Events 

On the Issue of 
Equipoise

Trial Documents &
CRFs Update 


 Additional Support 

Recruitment Details 


Congratulations to Mark Wilson (PI) and Hani Marcus (Co-PI) and their team at St. Mary's for being the top recruiters in October and November!
We would like to welcome Giles Critchley and Husam Georges and their team at the Royal Sussex County Hospital to the RESCUE-ASDH Trial!
We would like to welcome Jonathan Pollock, Geoffrey Tipper and Anouk Borg and their team at Queen's Hospital to the RESCUE-ASDH Trial!

Upcoming Events

 The study will be presented at the following conferences:

  • INTS 2016 - 12th Symposium of the International Neurotrauma Society, Cape Town, South Africa
  • British Neurosurgical Research Group Meeting, Cambridge, 17-18 March 2016
  • SBNS Spring Meeting Newcastle 2016, Newcastle

On the Issue of Equipoise
 

In this edition we would like to highlight a relevant survey:

  • As part of the survey, we asked the following question: “When evacuating a traumatic ASDH, how often do you perform a primary DC (i.e. leave the bone flap out)”? 
  • This question was answered by 283 neurosurgeons (201 Consultants; 82 trainees). There were 138 UK/Irish, 110 from other European countries, 13 North American and 22 respondents from various other countries. 
  • We found that a higher proportion of neurosurgeons from other European countries (48/110; 44 %) as compared with UK/Irish neurosurgeons (29/138; 21 %) use primary DC in more than half of ASDH cases (see Figure below, p<0.001). 
  • Of the 23 UK/Irish neurosurgical units with at least two Consultant respondents, only six units (26 %) showed intra-departmental agreement regarding the level of use of primary DC for ASDH.
  • We do not think that the observed variation in practice can be fully explained by regional/national differences in trauma care systems or the epidemiology of TBI within Europe. Rather, we believe that the variation in practice reflects the lack of high quality evidence regarding the use of primary DC for ASDH evacuation.
 


Any questions or comments regarding this section
please get in touch with us at info [at] rescueasdh.org
TRIAL DOCUMENTS AND CRFs UPDATE
 
To easily access trial documents and to simplify the CRF return process :
  • All trial documents (including CRFs, consent forms and information sheets) are now hosted on our website within the randomisation system. All centres can login to the randomisation system (www.rescueasdh.org) with their details and find all documents under the "Trial Documents" tab.
  • To simplify the CRF return process ALL CRFs can now be sent to rescueasdh [at] nhs.net . This includes both patient identifiable and non-identifiable information.
  • All sites have received the updated Trial Posters. Please ensure that the posters will be placed in theatre in order to have randomisation details available intra-operatively.
  • Any questions about trial documents, CRFs completion and return processes, or to order additional posters please contact our coordinator at: coordinator [at] rescueasdh.org

Additional Support for the RESCUE-ASDH Trial


If your centre requires...

  • a training session for the RESCUE-ASDH Trial

  • support or help with CRF completion

  • additional information regarding recruitment or administrative aspects of the trial

Please contact us at info [at] rescueasdh.org or get in touch with our study coordinator at +44 (0)1223 254919

Recruitment Details

  • We only have 4 months left of the pilot phase in which we need to reach the target of 120 randomised patients.
  • Randomised: 65 patients
  • Observational cohort: 60 patients
  • RESCUE-ASDH monthly recruitment rates shown below:

Total recruitment by centre:
   Randomised   Observational   Total
Cambridge 12 11 23
St Mary's Hospital, London 8 5 13
Bart's (Royal London) 7 2 9
Southampton 6 12 18
Liverpool 5 8 13
Bristol 4 5 9
Middlesbrough 4 0 4
King’s College Hospital, London 3 4 7
Nottingham 3 1 4
Leeds 3 0 3
Plymouth 2 2 4
Preston 2 2 4
St George's Hospital, London 2 1 3
Manchester 2 1 3
Birmingham 1 5 6
Sheffield 1 0 1
Brighton 0 1 1
Newcastle 0 0 0
Cardiff 0 0 0
Coventry 0 0 0
Oxford 0 0 0
Total 65 60 125
@rescueasdh   www.rescueasdh.org   info@rescueasdh.org
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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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