Military approves Tranexamic acid for major hemorrhage

[Doczilla]

Tranexamic acid has been approved for use in the Joint Theater Trauma System Clinical Practice Guidelines, including for prehospital use in patients expected to require massive transfusion. Civilian price is $9/dose, (military price about $1.50/dose) and it is shelf stable at room temperature. CPG is posted on the US Army Institute for Surgical Research website, and is attached here. I believe some civilian prehospital systems will follow suit in the future.

'zilla

Excerpt from August 2011 CPG:

Joint Theater Trauma System Clinical Practice Guideline

Guideline Only/Not a Substitute for Clinical Judgment

August 2011

Page 4 of 24 Damage Control Resuscitation At Level IIb/III Treatment Facilities

5. Tranexamic Acid

Tranexamic acid (TXA), an anti-fibrinolytic agent, has been used to decrease bleeding and

the need for blood transfusions in coronary artery bypass grafting (CABG), orthotopic liver

transplantation, hip and knee arthroplasty, and other surgical settings. A recent meta-analysis

reported that TXA is effective for preventing blood loss in surgery and reducing transfusion,

and was not associated with increased vascular occlusive events. 4 (For additional

information concerning TXA, see Appendix D).

The early use of TXA (i.e. as soon as possible after injury but ideally not later than 3 hours

post injury) should be strongly considered for any patient requiring blood products in the

treatment of combat-related hemorrhage and is most strongly advocated in patients judged

likely to require massive transfusion (e.g., significant injury and risk factors of massive

transfusion). It may be utilized in circumstances when in the judgment of the physician, a

casualty has life-threatening hemorrhagic injury and high potential for development of

coagulopathy or outright presence of coagulopathy. Use of TXA within 3 hours of injury is

associated with the greatest likelihood of clinical benefit. Initial use of TXA after 3 hours

post injury may have no benefit and may in fact worsen survival. Therefore it is strongly

recommended that TXA not be administered to patients when the time from injury is

known to be or suspected to be greater than 3 hours.

a. Considerations for Use

TXA (intravenous trade name: cyklokapron) is supplied in ampoules of 1000 mg in

10ml water for injection.

Infuse 1 gram of tranexamic acid in 100 ml of 0.9% NS over 10 minutes intravenously

in a separate IV line from any containing blood and blood products (more rapid

injection has been reported to cause hypotension). Hextend® should be avoided as a

carrier fluid.

Infuse a second 1-gram dose intravenously over 8 hours infused with 0.9% NS carrier.

There are presently no data from randomized controlled trials to support

administration of further doses to trauma patients. However, if a patient has received

the initial dosing of TXA and continues to show signs of ongoing hemorrhage, strong

consideration should be given to re-dosing the patient as above.

TXA may be administered to patients requiring MT even if they have an associated

TBI.

Joint Theater Trauma System Clinical Practice Guideline

Guideline Only/Not a Substitute for Clinical Judgment

August 2011

Page 5 of 24 Damage Control Resuscitation At Level IIb/III Treatment Facilities

In patients who continue to have life-threatening hemorrhage despite TXA use and

adequate 1:1:1 resuscitation, clinical judgment is warranted as to the use of additional

pro-coagulant agents such as rFVIIa.

b. Storage

Room temperature (15-30° Celsius / 59-86° Fahrenheit). Storage at temperatures great

than these may reduce or destroy the efficacy of TXA.

6. Recombinant Factor VIIa (rFVIIa)

Recombinant Factor VIIa (rFVIIa) has recently been associated with improved hemostasis

in combat casualties, decreasing blood loss by 23% (see Appendix C for more information

on the use of rFVIIa). The use of this product should be reserved for those patients likely to

require massive transfusion (e.g. significant injury and risk factors) and is at the discretion

of the treating physician. It should be the judgment of the provider that the casualty has a

life-threatening hemorrhage and coagulopathy.

1) Usual Dose: 100 mcg/kg intravenously; may be repeated in 20 minutes.

2) Contraindications: Active cardiac disease.

3) Storage: Refrigerate (2–8°C/36–46°F) prior to reconstitution and use. The FDA

recently approved a room temperature stable product. This will be distributed

throughout the USCENTCOM AOR as the current supplies are exhausted.

ETA: I included the FVIIa guidelines for reference as well, and expect we'll see a lot less Novoseven use now with TXA being approved.

[Paramagic]

Good stuff. The CRASH-2 study certainly looks like a compelling reason to start carrying tranaxemic acid. Cheap, easy to use, appears safe, easy to store: it almost seems too good to be true!

I'm sure that some of the more progressive civilian services will be looking at this before too long.

[scubanurse]

That sounds awesome... what a cost-effective way to manage blood loss... I hope it catches on and research continues into it's long-term affects.

[tniuqs]

This is a "to follow" new treatment and because of the cost has the potential of positively affect many lives .. especially in 3rd world humanitarian zones.

kudos ERDoc

[ERDoc]

This is a "to follow" new treatment and because of the cost has the potential of positively affect many lives .. especially in 3rd world humanitarian zones.

kudos ERDoc

Thanks, but I think you have your doctors mixed up. I know we all look the same so it can be confusing.

[tniuqs]

oops my bad ? ... dang those scrubs .

[JakeEMTP]

Interesting. I would hope to see this on EMS and Critical Care units. As you are well aware, most EMS advancements come from the military. This should be no exception.

I may have missed it in the reference, but what is the shelf life of Tranexamic Acid? I don't imagine you would use this everyday, but would be great to have on the unit. With this and quik clot (another thing we have thanks to our armed forces) a lot of folks would make it to surgery who otherwise would have bled out.

[DwayneEMTP]

Is there a specific definition of 'massive' in the medical community Doc? Or is it an 'Oh shit...he's gonna need a ton of blood' call?

Not criticizing as I can't see a down side to this either. Or, is there a down side to using it on patients that won't require massive transfusions? Say, the medic that freaks out of a distal, isolated amputation.

Pretty cool find...

Dwayne

[Just Plain Ruff]

that was exactly my question Dwayne.

Also, what happens if this medication is give while blood is being given at the same time?

I'm really curious as to the long term effects of a patient given this in a urban setting, 10 minutes from the trauma center. What does the medication do to the body if blood is given close to when the patient is given the TXA, which occurs in many urban settings.

Is the military allowing medics to give the TXA or is it being given at the field hospitals where a physician is present?

I'm all for this but there are ramifications for the Civilian EMS world. I would be reluctant to administer this drug in the field until EMS field trials are done. What are the benefits in a urban setting, what are the benefits in a rural setting? Will EMS be able to give this? Should EMS be able to give this?

[tniuqs]

For those interested some links.

The conclusions I take away from this is / are: the lower risk group of bleeding in trauma, because of the "high numbers" of that group statistically have the greater benefit over the higher risk groups, although in the high risk groups those with a systolic pressure < 90 and greater than 4 units of blood also will benefit, with very few adverse effects (best to watch the you tube presentation)

This from Ian Roberts is "considered" as Massive Transfusion. (~ 15:30 minute mark on the Ian Roberts presentation)

I can tell (in the ICU I worked) that compromised end organ perfusion and > than 10 units (this included cell saver or autologous blood salvage inter-operatively was included in "totals") ( inter-operatively and post operatively anything greater than ~ 20 units ) was defined as massive transfusion, the blood bank would be calling the unit and getting ethics committee involved.

http://www.google.ca...=UTF-8&q=CRASH2

I do not know if this pfd can be opened (had a tech glitch with this one)

http://download.thel...7361160278X.pdf

Edited August 30, 2011 by tniuqs