Army Stops Use of Wound Stat

[scubanurse]

WASHINGTON -- Until more testing can be done, Army medics are being told to stop using a new product just sent to the war front to help control bleeding among wounded troops.

Officials were in the process of distributing some 17,000 packets of WoundStat, granules that are poured into wounds when special bandages, tourniquets or other efforts won't work. But a recent study showed that, if used directly on injured blood vessels, the granules may lead to harmful blood clots, officials said Tuesday.

The Army Medical Command will continue its research and work with the manufacturer in hopes of figuring out in the next few months whether to resume use of WoundStat, said Col. Paul Cordts, head of Army health policy and services.

WoundStat manufacturer TraumaCure, Inc., of Bethesda, Md., had no immediate comment.

The product, which was developed at Virginia Commonwealth University, had been approved by the U.S. Food and Drug Administration. It was one of the latest in a series of Army efforts to improve survival rates on the battlefield.

Today, 90 percent of injured troops survive their wounds, the highest rate of any war, Cordts said in an interview. He credited better training of combat medics, better body armor the troops wear and better tactics they use on the battlefield, as well improved bandages, tourniquets and so on.

Defense Department figures show that as of this month, more than 4,800 troops have been killed in Iraq and the global war on terror. The latter category counts casualties mostly from Afghanistan. Some 34,000 troops have been wounded in the wars, where insurgents have made wide use of roadside bombs and other explosives.

Excessive blood loss is the number one killer on the battlefield, and the Army announced in October that it was sending two potential lifesavers -- the WoundStat packets and a bandage called Combat Gauze -- to replace older other products that had been in use at the time.

A committee of Army medics, Navy corpsmen, surgeons and others recommended the Combat Gauze bandage -- which has an agent that triggers blood clotting -- should be the first-line treatment for life-threatening hemorrhaging in cases where a tourniquet could not be placed, such as the armpit or groin area.

The WoundStat granules were to be used if the bandage failed to work.

Cordts said the Army put out a message on Dec. 18, directing the temporary halt in use of WoundStat. Though it has arrived at the war zones, officials are unclear on how widely it has been distributed so far. They're working to identify any soldiers who got the treatment, study their cases and examine them for any problems with blood clotting, Cordts said.

He said he didn't know whether it had been used on any soldiers and thus had no reports back from the field -- positive or negative -- on how effective it might have been.

Cordts said that after an additional few months of study, officials will likely determine whether they should discontinue its use altogether or perhaps redistribute it with warnings for how it is to be used.

More Information:

Army Medical Command

TraumaCure, Inc.

Copyright Associated Press

Any thoughts/experiences with Wound Stat that resulted in a clot?

[spenac]

Another reason I do not like to be the first to try new products. I hope it turns out they were wrong about it causing the clots, and then find it can save lives.

[Dustdevil]

Wow. A haemostatic causes clots?

Who'd a thunk it?

[scubanurse]

haha dust... i think they were more concerned about the clots traveling to the lungs or brain silly

[spenac]

Wow. A haemostatic causes clots?

Who'd a thunk it?

Wow we have to spell out everything for you don't we. Smart aleck. :twisted:

[firedoc5]

I saw it on the news. The first thing I thought when they mentioned that it was not believed a human had formed blot clots was that they were being over cautious and wondered what DD thought of it.

[Ecnalubma08]

[Doczilla]

UPDATE: Woundstat is being permanently pulled from Army use.

'zilla

PERMANENT SUSPENSION OF WOUNDSTAT USE

WHO: DA WASHINGTON DC//DASG

WHAT: PERMANENT SUSPENSION OF WOUNDSTAT USE

WHEN: N/A

WHERE: N/A

WHY: THIS ALARACT DIRECTS PERMANENT SUSPENSION OF WOUNDSTAT (WS) USE BY

MEDICAL PERSONNEL DUE TO SAFETY CONCERNS CONFIRMED BY THE US ARMY

INSTITUTE OF SURGICAL RESEARCH (USAISR). THIS IS A FOLLOW-UP TO ALARACT

313/2008 (24 DEC 08) ENTITLED "SUSPENSION OF THE USE OF WOUNDSTAT".

REF/A/ALARACT 185/2005/INDIVIDUAL SOLDIER HEMOSTATIC DRESSING/SEP 05//

REF/B/ALARACT 239/2008/NEW SOLDIER HEMOSTATIC DRESSINGS/SEP 08//

REF/C/ALARACT 313/2008/SUSPENSION OF USE OF WOUNDSTAT/DEC 08//

1. (U) THIS ALARACT DIRECTS PERMANENT SUSPENSION OF WOUNDSTAT (WS) USE

BY MEDICAL PERSONNEL DUE TO SAFETY CONCERNS CONFIRMED BY THE US ARMY

INSTITUTE OF SURGICAL RESEARCH (USAISR). THIS IS A FOLLOW-UP TO ALARACT

313/2008 (24 DEC 08) ENTITLED "SUSPENSION OF THE USE OF WOUNDSTAT".

2. (U) THE USAISR HAS COMPLETED THREE SAFETY STUDIES AND ONE

COAGULOPATHY (LOW LEVELS OF CLOTTING FACTORS) STUDY OF WS. WS MAY

INJURE THE LINING AND WALL OF BLOOD VESSELS IN COMBAT WOUNDS,

POTENTIALLY LEADING TO THE NEED FOR SURGICAL REPLACEMENT OF THE BLOOD

VESSEL. BECAUSE WS IS A FREE GRANULE, IT MAY TRAVEL TO OTHER PARTS OF

THE BODY (E.G., WS WAS FOUND IN THE LUNG OF TWO TEST ANIMALS) AND CAUSE

INJURY. FINALLY, A STUDY SHOWED THAT WS WAS NO MORE EFFECTIVE THAN

PLAIN GAUZE FOR TREATING COAGULOPATHIC BLEEDING.

3. (U) THE RISK INHERENT IN WS USE OUTWEIGHS ITS BENEFIT AS A BACK-UP

HEMOSTATIC AGENT TO COMBAT GAUZE (CG) FOR 68W COMBAT MEDICS. CG REMAINS

THE RECOMMENDED HEMOSTATIC AGENT FOR CURRENT COMBAT OPERATIONS. UNIT

COMMANDERS MAY REPLACE THE TWO WS ISSUED TO 68W COMBAT MEDICS WITH CG,

BASED ON MISSION REQUIREMENTS, IN ADDITION TO THE THREE CG ALREADY

ISSUED TO 68W COMBAT MEDICS.

4. (U) UNITS WILL CONTINUE TO TURN IN WS TO THEIR SUPPORTING MEDICAL

SUPPLY SUPPORT ACTIVITY (SSA). MEDICAL SSAS WILL COMPLETE 100% CONTACT

WITH UNITS ISSUED WS TO ENSURE TURN-IN OF PRODUCT IS COMPLETE. MEDICAL

SSAS WILL HOLD WS IN SUSPENDED STOCK STATUS UNTIL DISPOSITION

INSTRUCTIONS ARE RECEIVED FROM THE OFFICE OF THE SURGEON GENERAL (OTSG).

OTSG WILL PUBLISH DISPOSITION INSTRUCTIONS AT A FUTURE DATE.

[Chief1C]

Actcel Gauze seems to work okay. Had a little incident with my daguerreotypes. Stung like hell, but it didn't get hot. Though I found it difficult to remove with out making the bleeding worse. All in all, it would have been better off without, the volume of bleeding was just startling, rather than the severity.

[joesph]

So is it the free granules of the WS that is the problem or the agent itself because I think the haemostaic that is usedis the same as in other products where they are controlled in a sponge or dressing with the (assumption)the granules are controlled there. Alot of the wilderness EMT's carry these and we have talked of implementing a similar product.