Latest News
April 8, 2016
Would you like to help us save more lives?
C4TS are looking for former trauma patients who have experienced major bleeding to provide us with input on different aspects of designing and running a new clinical trial called CRYOSTAT-2.
CRYOSTAT-2 will evaluate a new and potentially life-saving treatment for trauma patients suffering from major bleeding. The trial will build upon the groundbreaking research we undertook for the CRYOSTAT-1 pilot.
The problem with bleeding
Life threatening bleeding after trauma or surgery is associated with death rates as high as 40% and most of these deaths happen within the first 6 hours.
Treatment of major bleeding has improved greatly in the last decade but we would like it to improve even further. We are planning a study (randomised controlled trial) to test how useful one of the treatments for major bleeding might be. This treatment is called cryoprecipitate.
Cryoprecipitate is a concentrated source of a clotting protein (fibrinogen). Fibrinogen is vital for forming stable blood clots. Fibrinogen blood levels fall very rapidly during major bleeding episodes and patients may benefit from fibrinogen replacement. Cryoprecipitate is already used as a treatment for patients with major bleeding but infusion is often quite late, ie. 3 hours or more after hospital admission.
What would we like to test?
We would like to test whether giving cryoprecipitate as soon as we can (within 30 minutes of admission) will stop a patient bleeding more quickly than current standards of care (ie where cryoprecipitate is used after 3 hours or not at all) and whether this early cryoprecipitate infusion will improve survival.
Who will be involved?
C4TS is applying for funding from the National Institute for Health Research to carry out this trial across England and Wales.
If the grant is approved, the trial will test the effect of the early cryoprecipitate, compared to standard blood transfusion therapy, on 1542 severely bleeding trauma patients at all 22 Major Trauma Centres across England and Wales. The institutions responsible for co-ordinating the study are: C4TS, NHS Blood and Transplant and Oxford University Hospitals.
Would you like to help?
Input would include (but is not limited to):
- Looking at the grant funding application we are putting into the NIHR to see if we have missed anything important from a patient or carer perspective (The application deadline is 25 May, 2016. If funded, the trial will commence in January 2017.)
- Provide feedback on the draft study protocol about how hospitals recruit and communicate with patients in the trial
- Provide feedback and help draft Patient Involvement Sheets and consent forms
- Alerting us to any ethical issues from a patient or carer perspective
- Help us ensure any communications about the trial to patients or other non-clinical people are in plain English and easy to understand
- Help us publicise the work and results from the study via newsletters, blogs, social media etc
During the trial itself, after we have begun recruiting patients, we may also ask you help with the following
- Reviewing recruitment rates to ensure we are on target and if not suggesting methods we could utilise to improve patient enrolment in the study
- Reviewing our consenting processes and helping improve the experience for patients and family members
Even if you haven’t experienced major bleeding as a result of our injury, we are still interested in the viewpoints of people who have experienced a near fatal injury as your experience provides you with empathy and insight into the impact of trauma.
What would all this involve?
There will be a CRYOSTAT-2 project Steering Committee which will meet in person approximately 4 times a year in London. We need one patient representative on the Steering Committee who can attend those meetings and be available for occasional questions via emails and phone-calls in between. All expenses for travel, accommodation (if needed), food and incidentals will be paid for.
In addition, we’d like to establish a patient reference group of 6 or more patients (and at least one carer) who could help the Steering Committee and patient rep with some or all of the tasks listed above. This group will meet face to face only as required, communication otherwise via email and phone. Any expenses you incur in your role will be covered (eg occasional travel), and we'll also cover refreshments and meals, and provide resources for training if required.
Benefits
By your involvement in CRYOSTAT-2, you will be contributing to a study that could eventually help save the lives of millions of trauma victims around the world.
In addition, we think the world of medical research is a fascinating one, and contributing to this trial provides you with the opportunity to learn about what running a national clinical trial involves. It also provides the opportunity to share your story and perspective with clinicians and scientists from all walks of life, to the benefit of future patients.
Interested?
If you think you might like to be part of Cryostat-2, or would like more information in the first instance, please contact our Communications Officer Nicole Skeltys: n.skeltys@qmul.ac.uk
The first meeting of patients who would like to be involved will be held on 3 May, 2-5pm, Blizard Institute, 4 Newark St, London E1 TA2.
Many thanks!
The CRYOSTAT-2 Team
