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

Newsletter October 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:

  • 50 patients have been randomised from 15 UK sites 
  • 50 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 

New Study Coordinator 

On the Issue of 
Equipoise

Additional Support 

 Randomisation Details 

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 September!
Congratulations to Daniel Holsgrove (PI) and James Barber (Co-PI) and their team at Salford Royal Hospital for enrolling their first participant!

Upcoming Events

 The study will be presented at the following conferences:

  • Neurotrauma Meeting on the 23rd October 2015 in London at the Royal Geographical Society
  • INTS 2016 - 12th Symposium of the International Neurotrauma Society, Cape Town
New Trial Coordinator joining  the RESCUE-ASDH Team


Dear Colleagues,
 
We are pleased to announce that Alicia Gore has joined our team as the new Trial Coordinator.

An introduction from Alicia:


"Originally from New Zealand I came to the UK 11 years ago via 2 years in Copenhagen; so I've nearly lost the Kiwi accent. I am a Molecular Biologist by background but have always had a strong interest in IT.  My first NHS position was in clinical IT and working on projects like the summary care record, and more recently the EPIC implementation at Addenbrookes.  However research lured me back and I have worked at Papworth for some years as a Research Study Coordinator, managing a portfolio of trials including cardiac (interventional and surgical), transplant and PVDU. I am delighted to have the opportunity to move to Addenbrooks to coordinate the international multi-site RESCUE-ASDH trial."

 


Alicia Gore
tel: +44 (0)1223 254919
email: alicia.gore [at] adenbrookes.nhs.uk

On the Issue of Equipoise
 

A few bullet points presenting the views of the RESCUE-ASDH Collaborative Group and the Trial Management Group on the issue of equipoise:

  • The RESCUE-ASDH is NOT targeting patients who have minor head trauma and need a small size craniotomy for evacuation of an ASDH (e.g. non-comatose patients with brain atrophy).
  • The RESCUE-ASDH is targeting patients with severe head trauma. There is consensus that such patients require a large bone flap (trauma flap) for evacuation of an ASDH.
  • There is also consensus that the bone flap should be left out if the brain is bulging outside the inner table of the skull.
  • However, there is variation in the management of patients who have evidence of severe trauma but their brain is not bulging outside the inner table of the skull. Even within the same units, some people say "leave the bone flap out, only if you can't put it back in" but others say "if in doubt, leave it out"1.
  • This might not show equipoise at an individual level but shows that there is uncertainty at a specialty level - which is more important.
  • In addition, there is evidence that about 2/3 of patients have raised intracranial pressure after ASDH evacuation - and this is associated with higher mortality2. Moreover, 2 recent cohort comparison studies found a trend towards better outcomes with a hemi-craniectomy (i.e. bone flap left out after ASDH evacuation)3,4. This shows that there is a good physiological and clinical basis for leaving the bone flap out rather than replacing it in this group of patients.
  • The downside of leaving the bone flap out is that patients will need to have a cranioplasty a few months later. There is ongoing concern about the complications –particularly infection– following cranioplasty. There is also a concern about the additional costs.
  • On the one hand, hemi-craniectomy can potentially improve outcomes and/or reduce mortality but on the other hand, the subsequent cranioplasty is not a benign procedure. An objective appraisal of the available evidence suggests that we should be in a position of uncertainty / equipoise at a specialty level.
  • In view of this uncertainty, a multi-institutional consortium of co-applicants –with the support of the SBNS neurotrauma group and the British Neurosurgical Trainee Research Collaborative– designed the RESCUE-ASDH trial.
  • The fact that the study was funded by the NIHR following extensive peer-review shows that this is at least a legitimate research question. Hence, the study is worthy of support even though some surgeons may feel that they lack equipoise.
  • Hence, we feel that most patients who have a large bone flap and whose brain is not bulging outside the inner table can be randomised in the RESCUE-ASDH study. This is an ethical option in view of the available evidence and existing uncertainty. At the same time, this will assist in completing the study quickly and will add to the strength of the results.    
Any questions or comments regarding this section
please get in touch with us at info@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@rescueasdh.org or get in touch with our study coordinator at +44 (0)1223 254919

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 5 months left of the pilot phase in which we need to reach the target of 120 randomised patients.
  • Randomised: 50 patients
  • Observational cohort: 50 patients
  • RESCUE-ASDH monthly recruitment rates shown below:

Total recruitment by centre:
 
  Randomised Observational Total
Cambridge 10 10 20
St Mary's Hospital, London 6 4 10
Liverpool 5 7 12
Bart's (Royal London) 5 2 7
Southampton 4 9 13
Bristol 4 5 9
Nottingham 3 1 4
Leeds 3 0 3
King’s College Hospital, London 2 4 6
Plymouth 2 2 4
Middlesbrough 2 0 2
St George's Hospital, London 1 1 2
Manchester 1 1 2
Preston 1 1 2
Sheffield 1 0 1
Birmingham 0 3 3
Brighton 0 0 0
Newcastle 0 0 0
Cardiff 0 0 0
Coventry 0 0 0
Oxford 0 0 0
Total 50 50 100
@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

Add us to your address book



Want to change how you receive these emails? You can update your preferences or unsubscribe from this list