Should any treatment be withheld from patients in this trial?
NO! Please inform patients and/or their
families that they will be receiving all the treatments required and that the
CRASH2 treatment is given as an additional treatment.
How is it decided whether the patient receives the treatment
or placebo? We randomise so that each patient
has a known, usually equal, chance of being allocated to either group and importantly
the allocation cannot be predicted. This ensures that both groups will be equal
for all the variables (patients characteristics, other interventions received
etc) except for the intervention under study tranexamic acid.
How can I increase recruitment? Ensuring
good lines of communication between all members of your team including nurses.
Building a team of doctors to help with randomisation and with completing and
sending the data forms. Passing on some of the incentives we send to you
to any person who helps you is a good way of motivating them. Ensure all
relevant staff e.g. everyone in the emergency department, are informed about the
trial, including those working in the blood bank. We can provide posters, newsletters
or even formal letters to help with this process.
What should I do if a trial patient is moved to a different
department? Ensure the staff in that department
are aware of the study. You can do this by sending them a cover letter with your
contact details should they require further information, and a Protocol Summary.
We are happy to write a letter to the head of any other department to aid this,
if you wish.
How do I make sure I am conducting the trial to Good Clinical
Practice standards? It is vital that all
investigators working on CRASH2 complete Good Clinical Practice training. We provide
training for collaborators on the trial intranet. Please let us know if you need
access. All staff helping you with the trial should also be trained in the
trial procedures using the PowerPoint presentation which is included in your site
file.
I am losing eligible patients to local hospitals what should
I do? Please
try your best to get your local hospitals to collaborate. Send us their contact
details and we will try to get the trial started there! |