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Fri Jun 18 19:51:56 BST 2010

Only for drug trials. We got permission for delayed consent for trials  
such as SAFE, NICE and RENAL because we had data that both treatments  
were already in common usage - we merely wished to study them  
systematically. The rules are different for investigational new drug  
trials and unfortunately TXA counted as such as it was NOT otherwise  
available for use.

Ian

On 19/06/2010, at 1:24 AM, "McSwain, Norman E" <nmcswai at tulane.edu>  
wrote:

> Seems like you have similar informed consent problems for acute  
> trauma in Australia that we do in the US
>
> Norman
>
> Norman McSwain MD
> Trauma Director, Spirit of Charity Trauma Center
> Professor of Surgery, Tulane University
> New Orleans LA
> 504 988 5111
> norman.mcswain at tulane.edu <mailto:norman.mcswain at tulane.edu>
>
> ________________________________
>
> From: trauma-list-bounces at trauma.org on behalf of Ian Seppelt
> Sent: Fri 6/18/2010 7:44 AM
> To: Trauma-List [TRAUMA.ORG]
> Cc: Trauma-List [TRAUMA.ORG]
> Subject: Re: CRASH2
>
>
>
> Concerning US participation, while I don't know the precise US
> situation it is likely to be due to the regulatory environment.
>
> Australia contributed a whole 17 patients, most of them recruited by
> me. The problems we had were:
>
> 1. The simultaneous phase III rVIIa trial, which meant many trauma
> centres did that study ($) and could not participate in CRASH2 (done
> for love and no $)
>
> 2. Because IV TXA is not marketed in Australia I had to register it as
> a new drug under the Clinical Trials Notification scheme of the
> therapeutic goods administration. This requires prospective consent by
> participants (no delayed assent allowed).
>
> 3. Some time into the trial I got permission to enrol patients using
> prospective proxy consent, but this still required locating next of
> kin and getting permission before starting the drug. Bad traumas, esp
> anyone who was rushed straight to the operating theatre, could
> therefore not be included.
>
> This somewhat stifling regulatory environment makes any RCT in severe
> trauma very hard to do.
>
> Interested to hear about country specific problems other investigators
> had.
>
> Ian
>
>
>
> On 15/06/2010, at 6:33 PM, "Philip Munro" <ptmunro at doctors.org.uk>
> wrote:
>
>> Rowley
>>
>> Many thanks for the heads up. This is enormously important and will
>> probably become standard practice within trauma care certainly here
>> in the UK.  I think we should all read this VERY carefully. I
>> suspect we will in the very hear future be using 1:1 blood product
>> regimes and tranexamic acid routinely for trauma with ongoing
>> haemorrhage not fully resolvable by surgical intervention alone.
>>
>> Given that Karim is one of the collaborators, have the Royal London
>> started doing this?
>>
>> I didn't see any US participants in the trial centres. Were there
>> any blocks to them being able to take part?
>>
>> Kind regards.
>> Phil Munro
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