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Hemorrhagic Shock Treatment System Would you carry/deploy a drug delivery device for shock?

#1 User is offline   VMX 

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Posted 04 February 2009 - 08:58 PM

We could really use some help from the Military Transport forum with feedback about a new technology we are developing.

We are developing a small volume [<400ml] battlefield deployable automated delivery system with pre-loaded cartridges containing a new parenteral drug formulation that sustains metabolic function and cell integrity during severe ischemia and reperfusion. The goals are to extend the “golden hour” post-trauma by 3-4x, to protect organ systems and the brain from additional damage prior to and during the blood replacement process. The route of delivery will be intraosseous or intravenous and the device will automate the delivery regimen once deployed.

The battlefield deployable kit will have the drug pre-loaded into cartridges and will include necessary equipment for quick infusion starts and will be designed to meet critical criteria for battlefield and civilian EMS use including: stable at broad ambient conditions fannypack/backpack transportable and simple/failsafe delivery of therapy per the prescribed regimen. In addition to saving lives, it is also anticipated that the technology will reduce the number of limb amputations by preventing tissue death due to sustained severe blood loss.

Medics would be tasked with deploying the system in the battlefield/during transport so their input is critical to our continuing this program. We have talked to Command personnel [MRMC/CCCR/USAISR] and have been encouraged by their interest. However, recently, a research scientist that runs the resuscitation research lab at USAISR said medics wouldn’t carry/deploy it. So… we need to get as much feedback as possible from those that really matter.

The big question: Would a Medic carry/deploy a drug delivery system that is about ˝ the size of a cigar box if it sustains life in a severely bleeding warfighter?

We look forward to your response. We really need input from the “front line” professionals.
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#2 User is offline   Gila 

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Posted 05 February 2009 - 02:18 AM

What exactly is this new metabolic wonder drug? In addition, the "golden hour," while a really dramatic sounding term, is not based on any solid evidence. Hate to call you out; however, you are going to have to give us a little more information if you expect us to make any educated or relevant comments about this product.
Christopher Bare
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#3 User is offline   VMX 

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Posted 05 February 2009 - 03:29 PM

View PostGila, on Feb 4 2009, 09:18 PM, said:

What exactly is this new metabolic wonder drug? In addition, the "golden hour," while a really dramatic sounding term, is not based on any solid evidence. Hate to call you out; however, you are going to have to give us a little more information if you expect us to make any educated or relevant comments about this product.




I don't mind filling in more information. I wasn't sure how much detail to provide.

The drug, called Tamiasyn was developed under Defense Advanced Research Projects Agency (DARPA) funding at the University of Minnesota and is based on many years of hibernation research performed by Professors Matthew Andrews and Lester Drewes. Examining differences between hibernating and non-hibernating ground squirrels led to the hypothesis that use of ketone bodies such as β-hydroxybutyrate rather than glucose as a primary fuel source could promote survival under extreme physiological conditions. In addition to experiencing a switch from glucose as a primary fuel source to fatty acid metabolism, hibernators also experience changes in serum melatonin concentration. In particular, hibernators selectively turn on melatonin production as they come out of hibernation and this finding led to the hypothesis that the anti-oxidant property of melatonin can prevent ischemia-reperfusion injury.

Tamiasyn is designed to prevent damage to the major organs that typically occurs when severe blood loss and hemorrhagic shock exceeds the body’s ability to compensate. Tamiasyn is designed as a metabolic/biochemical therapy in a hypertonic formulation with multiple metabolic and biochemical functions including the use of: (1) biologically active ketones to provide energy to cells most efficiently under conditions where oxygen demand is greater than oxygen supply, (2) an anti-oxidant to protect cells from severe oxidative damage that occurs during blood loss and resuscitation and (3) hypertonicity to expand plasma volume in shock. This is a new approach to sustaining cellular function and integrity over time which should translate to improving outcome for trauma patients and wounded combatants suffering from severe blood loss.

EFFICACY OF TAMIASYN
Efficacy of Tamiasyn has been evaluated in rat and pig models of hemorrhagic shock. Administration of Tamiasyn significantly increased survival in rats subjected to 60% blood loss as compared to controls. Indeed, there was no significant difference in survival between Tamiasyn treated animals and sham operated animals that were not subjected to blood loss. In contrast, 90% of control animals that were subjected to 60% blood loss and administered a saline solution died within 48 hours of blood return.

In a clinically-relevant model of human hemorrhagic shock using pigs, initial results have shown great promise that Tamiasyn will be efficacious in humans. A pig model of hemorrhagic shock was used because the anatomy of the pig’s organ systems as well as physiological and pathophysiological responses have been found to be similar to humans. Hemorrhagic shock was induced in pigs by severe blood loss. Key clinical parameters used by clinicians to monitor the success of resuscitation following acute blood loss in humans were monitored in the pigs. Administration of Tamiasyn was found to improve key clinical metrics such as tissue oxygen saturation, base deficit, cardiac output, and volume of fluid needed for resuscitation.

We believe Tamiasyn has a significant clinical value in its ability to sustain cellular function and the value is likely time-dependent. It can sustain function if on board quickly. The next step is clinical trials and that is a big investment.

The first indication that Tamiasyn is being developed for is acute blood loss resulting in hemorrhagic shock which is often due to penetrating and non penetrating trauma and can lead to mortality in otherwise salvageable warfighters. Tamiasyn will be administered on the battlefield/accident scenes by medics or other EMS personnel intravenously (IV) or by intraosseous (IO) routes.

The product will be a combination of Tamiasyn and a delivery device. The Hemorrhagic Shock Treatment System [HSTS] will be a battlefield deployable device comprising cartridges pre-loaded with Tamiasyn in a simple failsafe drug delivery system. It is envisioned that the HSTS will also contain all components necessary for rapid parenteral infusion of a programmed delivery regimen prior to and during transport as well as during resuscitation. The delivery device is intended to be deployable on the battlefield or in transit to administer Tamiasyn. The delivery system will be compact [ again, ab out 1/2 the size of a cigar box], require little training to use, and perform well in austere environments.

The system is designed with a simple 2 button interface to activate, purge and initiate treatment.

If I knew how to include images I would show you the HSTS and animal study results. Or I can also send them to anyone that is interested.

Total dose to be delivered is approximately 400ml in an adult male over a 2 hour period.

I apologize for using the term "Golden Hour". I was trying to keep the description simple.

So, the question is... IF Tamiasyn is pushed forward to clinical trials and it shows efficacy - sustaining cell function during severe ischemia and protecting against reperfusion injury, would military medics and paramedics be willing to carry and deploy the HSTS in the field and in transit?

If you would like more information, please let me know.
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#4 User is offline   SAR Nurse 

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Posted 08 February 2009 - 06:37 AM

Can you reference any peer reviewed publications?

Matt
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#5 User is offline   Gila 

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Posted 08 February 2009 - 02:00 PM

It does not look like the product has been through clinical trials. Need to give this one a few years. I would say, yes medics would use the produce if, and I say only if the product works.
Christopher Bare
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#6 User is offline   GravyMedic 

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Posted 09 February 2009 - 06:00 AM

View PostGila, on Feb 8 2009, 10:00 AM, said:

It does not look like the product has been through clinical trials. Need to give this one a few years. I would say, yes medics would use the produce if, and I say only if the product works.



Agree... I'm not really sure where the discussion can go from here. Why would any medic choose not to carry/use something that would be shown too work? Hell, we carry enough CRAP as it is already, whats one more thing.
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#7 User is offline   VMX 

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Posted 09 February 2009 - 03:40 PM

View PostGravyMedic, on Feb 9 2009, 01:00 AM, said:

Agree... I'm not really sure where the discussion can go from here. Why would any medic choose not to carry/use something that would be shown too work? Hell, we carry enough CRAP as it is already, whats one more thing.



Well, you see that is the dilemma. We are getting a mixed message. From Command, we hear... yes, absolutely interested. But... recently we were told by key research scientists within the military [not decision makers, but definitely decision influencers] that you guys won't carry/deploy this system because it is not just a simple bolus injection. Even if it is a "start and forget" delivery system. GILA - you are correct... clinicals are scheduled to begin soon, but our mission all along has been to design a system that treats the warfighter and get it to the battlefield ASAP. Why? We think this will have clinical value for non-compressible wounds since it not a blood substitute or replacement.

If military is not the initial target, then we need to modify our plans. I don't want to make that decision without feedback - from Medics. That is why I came to this forum. Feel free to call me if you prefer.

V/R
Jeff
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#8 User is offline   SickPuppy 

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Posted 22 February 2009 - 07:24 PM

It sounds like a great idea, but I'm not sure just how much impact you'd have. Most people injured undergo damage control surgery and resuscitation well within the "golden hour." Further, most limb amputations are done because the damage is just too severe to salvage the limb. Also, almost all limbs that are amputated require tourniquets immediately at POI, so no drug could reach those tissues anyway.

The drug may have some usefulness in preventing secondary brain injuries, but I don't see much more benefit in other injuries. It will be interesting to see how the clinical trials play out.
"Education is only the further realization of your own ignorance." Albert Einstein

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#9 User is offline   chris 

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Posted 23 February 2009 - 05:57 PM

If it works, it might be a good adjunct to therapy for rural trauma patients that have a long transport time. Would be interesting to see how this affects mortality and morbity.

Chris
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