Clamps!

[Steve Dralle]

For full disclosure, I am from the company that makes the iTClamp (Innovative Trauma Care) and am in charge of marketing (though I do at least come from a Paramedic background, still licensed in Texas).

Some of you were asking for data, here is a link to a pre-clinical (swine hemorrhage model) study which is on-line with Prehospital Emergency Care now (will be in print in their fall or winter issue): http://informahealthcare.com/doi/abs/10.3109/10903127.2013.818177

I know human data would be best but as most of you probably know, getting IRB approval for human trauma research is very, very difficult. We are working on some projects but this is the reason why most hemorrhage data out there is in animal models.

Another study, using a perfused cadaver model, was also done to demonstrate effectiveness in human anatomy, it was presented at the recent Military Health System Research Symposium (MHSRS) in August of 2013 and won the gold award for best presentation overall (sorry, had to add the award part...I am in marketing). We are submitted the manuscript for publication in a peer review journal but I have attached a PDF of the poster for you here.

Finally, I have attached a CT Angiography of the device on a femoral artery injury (in the perfused cadaver model) in which we placed the clamp while the subject was "bleeding" then injected high pressure contrast and took the CT image. You can see the wound pocket does very effectively contain the blood, and as one mentioned does create a pseudo-aneurism but this is not a bad situation in this context as it allows continued perfusion of the the distal extremity until the wound can be permanently repaired.

So, tried my best to keep out the marketing speak, look at the data, look at the image, if you have question feel free to reach out to me. Note: it was just recently used in the US on a patient with Hospital Wing air ambulance in Memphis, TN, you can check them out on FB and the news release is out there in the media.

Thanks,

Steve

Steve Dralle, MBA, LP

Innovative Trauma Care

Poster iTClamp50 MHSRS 2013-LoRes.pdf

[EMT City Administrator]

Above post approved

[chbare]

Steve, please do not take offence. I tend to be very skeptical of any new claims, even when they turn out to be verified and or validated.

However, I absolutely appreciate you coming out and putting your name on this product while directly engaging us as providers. I respect that and I respect the fact that you are providing us with evidence and admitting that the overall evidence base is still limited.

I really hope additional studies continue to be positive and I hope your product becomes popular and well recognised for its quality and efficacy. I'm certainly excited and want to see you guys break out.

Good luck and thank you for posting on behalf of this product. It was a pretty stand up move IMHO.

[scubanurse]

Just a random thought I figured I'd throw out here... with that angiogram you posted, how would the hematoma formation affect limb perfusion? I understand it's use, especially in this case, is life over limb, but just thinking long-term....again probably a stupid thought but figured what have I got to loose.

[chbare]

It looks like distal circulation is preserved in the cadaver model.

[mobey]

Just a random thought I figured I'd throw out here... with that angiogram you posted, how would the hematoma formation affect limb perfusion? I understand it's use, especially in this case, is life over limb, but just thinking long-term....again probably a stupid thought but figured what have I got to loose.

These are not designed for long term use. They are designed as an adjunct or alternative to a tourniquet.

Btw: There are no stupid questions.... only stupid answers