Study news and updates

December 2011

Season’s greetings and a Happy New Year to all
from the RESCUEicp team!

327 patients have now been recruited. With only 73 to go, with one last big push
we can complete the RESCUEicp study recruitment in 2012!!

The hamper winners are Liverpool and Lima, Peru (joint highest recruiters during
3rd quarter of 2011). Congratulations to the local PIs and research staff!

We have been granted a trial extension until December 2014 by the MRC/NIHR! If
recruitment ends in December 2012, this will give us enough time to complete the 2
year follow-up for all patients.

A very warm welcome to 5 new RESCUEicp sites: Stony Brook (New York), Toulouse, Bordeaux, Marseille and Paris.

Thank you to all the centres and local investigators/research staff who have worked and are still working so hard to ensure all eligible patients with refractory raised ICP get recruited in the study!

April 2011

The results of the DECRA study (Australian decompressive craniectomy trial) have been published. Free full text is available online at http://www.nejm.org/.

Clinical outcomes, as assessed by scores on the Extended Glasgow Outcome
Scale, were worse in the surgical group than in the standard-care group.

The study showed a significant decrease in intracranial pressure in patients in the surgical group. However, although ICP was lowered by surgery, ICP was not excessively high in the medical group (mean ICP below 24 mmHg pre-randomisation).

RESCUEicp differs from DECRA in terms of ICP threshold (25 vs 20 mmHg), timing of surgery (any time after injury vs within 72 hours post-injury), acceptance of contusions and longer follow up (2 years).

The cohort profiles and criteria for entry and randomisation between the DECRA and RESCUEicp are therefore very different. Hence the results from the DECRA study should not deter recruitment into RESCUEicp. Randomising patients into the RESCUEicp study is now even more important!

We congratulate AMH/St George’s for being the highest recruiter during the first quarter of 2011! Southampton was the highest recruiter during the last quarter of 2010.

The study have now passed the 300 patients mark - please continue recruting all eligible patients!

December 2010
We would like to thank everyone for their contributions to the study in the last year. Please continue your great work and keep recruiting patients in 2011!

Best wishes for the New Year 2011 from the RESCUEicp team!

November 2010

15 patients were recruited during the last quarter (July-September 2010). We congratulate Hospital Do Oeste for being the highest recruiter! A lovely hamper should be on its way to you!

August 2010

Congratulations to Liverpool, Nottingham, Coventry, Bursa, Wurzburg and Thessaloniki for recruiting their first patient!

The Royal London Hospital is the winner of the highest recruiting centre hamper for the 2nd quarter of 2010 – Congratulations!

Welcome to our new research fellow Mr Angelos Kolias. After qualifying as a doctor, he studied for the MSc in Clinical Neuroscience (London) and following that he completed his Core Surgical Training with placements in Neurosurgery and Neurocritical Care (Addenbrookes Hospital). He will be looking after the study on a day-to-day basis and will be studying for a PhD in Neurotrauma. Good luck!

The crossover rate remains relatively high. This has the potential to affect the results. A significant proportion of patients are crossing over in less than 24 hours after initiating the primary randomised treatment. We would like to stress that patients should undergo cross-over only under extreme circumstances.

April 2009

The study is approaching 200 patients landmark. We would like to thank all investigators for ongoing effort in recruiting all suitable patients into the study! As a small token of appreciation we will be now awarding the highest recruiting centre per quater with a hamper.

February 2009

Small changes to the data collection proforma were made. We would like to ask all centres to return a copy of an operation note for “surgical patients” with the completed proforma.

As always, all up-to-date forms and documents are available from the “downloads” section of the website.

We would like to draw your attention to the need of reporting all serious adverse events (SAE’s) in the study within 7 days of their occurrence!

October 2008

• An investigators’ meeting for the study was held in Cambridge on 1-2 October 2008. It demonstrated ongoing interest and strong commitment to the study from many centres worldwide. We would like to thank all current investigators for their active participation in the trial and welcome new interested centres to join the study.

• The Steering Committee for the study met in October 2008 and the members were satisfied with the progress of the study. The Committee stressed the need to continue recruiting all eligible patients in each participating centre and to avoid crossovers if at all possible!!
  
  
• The Data Monitoring Committee (DMC) met on the 30/10/2008 and concluded that the recruitment in the trial should continue until further review in March 2008.

May 2008

Investigators meeting for the study will be held in Cambridge on 1-2 October 2008. We would like to invite all local principal investigators and further information will be available soon.

• The Steering Committee for the study met in March 2008 and the members were happy with the conduct and progress of the study. The Committee stressed the need to increase recruitment rates and we ask all centres to continue recruiting all eligible patients, please!
  
  
• The Data Monitoring Committee (DMC) met on the 18/04/2008 and concluded that the recruitment in the trial should continue until further review in October 2008. Crossover was highlighted as one of the important issues in the study and we urge all investigators to avoid crossovers if at all possible!
  
  
• Small changes to the data collection proforma were made following advice from the DMC. We would also like to remind all centres that according to the Good Clinical Practice standards they need to keep local copies of all RESCUEicp related documentation and in particular all study consent forms and data collection proformas!
  
  
• Please also note that all serious adverse events (SAE) concerning the patients in the study need to be reported on the SAE form. The SAE form, guidance and all other up-to-date forms are available from the “downloads” section.
  
  
• Study progress
  The study has recruited 150 patients to date! Well done everyone!! The top five recruiting centres are Cambridge, Leeds, Royal London, Newcastle and Southampton. Please continue recruiting all eligible patients into the study!
  

December 2007

We wish everyone Merry Christmas and a Happy New Year 2008!

November 2007

The data monitoring committee for the study met on the 28/09/2007 and following review of current recruitment and outcome data available to date concluded that the trial is proceeding well and recruitment should continue.

Following recommendation from the steering committee we have updated the follow-up forms and randomisation sheet form and implemented the eligible patients screening log. The follow up forms now include questions about shunting operations and cranioplasty. The ranomisation sheet was amended to include more detailed patient information and can now be filled in electronically and send via email as well as by fax. The screening log will enable us to identify patients that could, but for certain reasons did not take part in the study. This log will need to be completed by all centres and is self-explanatory.

NEW STUDY CENTRES: The John Radcliffe Hospital (Oxford) and University Hospital of Ulm (Germany) have recently recruited their first patients! Congratulations! We thank all centres for ongoing participation in the trial and please keep recruiting!

August 2007

 Please note the following important changes in the study protocol!

In the process of recent review by the MRC board and independent reviewers the following adjustments to the study were recommended and adopted, after discussion with the steering committee, resulting in changes to the protocol and relevant documents:

1. Increase in the study sample size to 600 patients (compared to 400 previously). This will increase the power or sensitivity of the study (ability to detect 10% difference between the study arms).
2. Detailed health-economic analysis will be performed as part of outcome assessment. This will be performed using already collected forms (SF-36).
3. Follow-up duration will increase to 2 years, involving additional assessment of the patients (using the same outcome assessment forms) at 1 year and 2 years. This extension will apply to all centres and is aimed at evaluation of the longer term effects of both treatment options as well as assisting with health-economic analysis.
4. As the result of the above the duration of the main phase of the study will increase to 5 years (01.04.2007 – 01.04.2012) – 3 years patient recruitment and 2 years follow up.
5. Children equivalent of SF-36 form – SF-10 form will be used for assessment of outcome in children below the age of 16, as it is considered to be more appropriate for this age group.
6. In the light of the recently published results of the “CRASH trial ”, demonstrating adverse effect of high dose steroid therapy after head injury, we no longer recommend high dose steroid therapy as an advanced measure of intracranial pressure control. However, steroids can continue to be used in lower doses as a necessary physiological replacement or for treatment of severe sepsis.

The amendments have been approved by the Cambridgeshire 4 Research Ethics Committee (former UK Multi Centre Research Ethics Committee, Eastern Region) and the up to date version of the protocol is available from this website to read and download. Relative information sheet has also been updated to include longer duration of follow up.

July 2007
The RESCUEicp investigators meeting will be held at the EANS congress in Glasgow on the 2nd of September 2007, 12:30 - 14:00 pm (lunch will be provided). We welcome all investigators to attend.

May 2007
The study has passed the 100 patients mark. We thank all centres for active participation. Please continue enrolling suitable patients into the study.

March 2007
We are very pleased to announce that definitive funding has been awarded by the Medical Research Council for the RESCUEicp decompressive craniectomy study! We would like to thank everybody who has been involved in the study so far, particularly in terms of patient recruitment and look forward to continuing to work with all the current centres and welcoming new centres.

Best wishes,

The RESCUEicp team

December 2006
The study has 35 centres which are already recruiting or have obtained favourable ethical opinion and ready to start the recruitment. Many more centres expressed interest in the study and are preparing to join. To date we have enrolled 82 patients. We would like to thank everyone for all your hard work and contributions without which all this would not have been possible. We greatly appreciate all your help with keeping the study going.

We wish you all Merry Christmas and a Happy New Year 2007!

November 2006
We have updated the information section on applications for ethical approval for new UK and overseas centres. UK centres should now be able to print out all the necessary supporting documents and make the application online via the COREC website. All overseas centres are required to sign an agreement form. Please contact Liz Corteen or Ivan Timofeev for further information.

October 2006
Please note that in view of the CRASH trial results we can no longer recommend the use of high dose corticosteroids as an ICP reducing intervention at stage 2 of the protocol. However, participating centres may continue to use steroids in the physiological replacement dose if they feel it is appropriate.

June 2006
Pilot phase of the study (50 patients) has been completed. Data have been reviewed by data monitoring committee members, who agreed that study is progressing satisfactorily and should proceed with recruitment.