Frequently Asked Questions



Efficacy

Is it effective?

Yes. In several independent studies comparing multiple hemostatic products or standard of care treatments, QuikClot® products were found to have superior efficacy.1-5,11 The CoTCCC recommends QuikClot Combat Gauze® as the hemostatic agent of choice for compressible hemorrhage not amenable to tourniquet use or as an adjunct to tourniquet removal if evacuation time is anticipated to be longer than 2 hours.6 Anecdotal reports of use so far in other settings, such as in hospitals and by law enforcement, have been overwhelmingly positive.

Do QuikClot® devices work on the clotting cascade?

Yes. Contact between kaolin and blood immediately initiates the clotting process by activating factor XII of the clotting cascade.4 This reaction leads to the transformation of factor XII, factor XI, and prekallikrein to their activated forms.13 In addition, factor XII can activate prekallikrein even without kaolin, but kaolin presence markedly enhances the rate of activation. The activation of both factor XI and factor XII leads to the rest of the coagulation cascade.13


General

What are QuikClot® hemostatic devices?

QuikClot® products have evolved over several years. These kaolin-based gauze products represent the third and latest generation of technology in the QuikClot® family of products for hemostasis. The active ingredient, kaolin, is impregnated onto the nonwoven polyester/rayon gauze for easy and familiar application.

How are QuikClot® devices different from surgical gauze?

QuikClot® devices are as intuitive to use as surgical dressings; however, they are impregnated with kaolin, an inorganic mineral that has been known for more than half a century to accelerate the body’s natural clotting cascade.7

What is the active ingredient in QuikClot® hemostatic devices?

The active ingredient found in the newest generation of QuikClot® devices is a naturally occurring inorganic mineral called kaolin, which has been known for more than half a century to clot blood.7 QuikClot® products do not contain animal proteins, human proteins, or botanicals, so there is low-to-no risk of allergic reaction.1,4

Is the active ingredient in QuikClot® devices a drug or biologic?

Neither. Unlike other commonly used hemostatic devices, QuikClot® products do not contain animal or human proteins, which may cause allergic reactions. The active ingredient in the newest generation of QuikClot® dressings is a naturally occurring inorganic mineral called kaolin, which has been known for more than half a century to clot blood.7

Is QuikClot® sold outside of the United States?

Yes, QuikClot® is currently being sold in several countries outside of the United States. Please contact us for more information.

Is Z-Medica® associated with any GPOs (Group Purchasing Organizations)?

Yes, we currently have agreements with Premier Inc., MedAssets®, HealthTrustSM and Novation®.


Hospital & EMS

Which QuikClot® devices are right for hospitals, EMS/first responders, and other healthcare organizations?

A variety of QuikClot® devices are available for hospitals, EMS/first responders, and other healthcare organizations for various situations and settings. QuikClot® products are in a variety of forms including 4x4 dressings, trauma pads, rolled dressings, and z-folded dressings. 

Are QuikClot® devices cleared by the FDA for use in the hospital?

Yes. Z-Medica received 510(k) clearance to market QuikClot® (prescription) in October 2007 under 510(k) number K072474. Additional clearances include the subcutaneous surgical wound indication under 510(k) number K123387, and the interventional indications under 510(k) K090620 and K120782. These FDA decisions can be viewed by entering any of the 510(k) numbers here.


Law Enforcement

Which QuikClot® devices are right for law enforcement use?

A variety of QuikClot® devices are available for law enforcement use in various situations and settings. QuikClot® products are packaged in different forms such as convenient belt trauma kits.


Military

Which QuikClot® devices are cleared for military use?

QuikClot Combat Gauze® is the hemostatic agent of choice for compressible hemorrhage not amenable to tourniquet use or as an adjunct to tourniquet removal if evacuation time is anticipated to be longer than 2 hours.6 QuikClot® devices are available in several forms that are appropriate for various situations and settings. 


Safety

Is it safe?

Yes. Kaolin, the active ingredient in QuikClot® devices, is an inorganic mineral. There are no known contraindications and low-to-no risk of allergic reactions.1,4

Are there any allergic reactions with the use of QuikClot® devices?

The active ingredient in QuikClot® devices is kaolin, a naturally occurring inorganic mineral and not a drug, animal protein, or human protein. There are no known contraindications or risks of allergic reactions.1,4

Does it burn?

No. QuikClot kaolin products do not produce heat. 

If kaolin comes off of the dressing, are there any adverse effects?

Several studies have been performed to assess the safety of the kaolin-based products10 including biocompatibility studies.8 These studies have shown that kaolin is safe and has no negative effect on tissues.


Training & Education

Does QuikClot® offer training and education for teams?

Yes, QuikClot® offers online and live training. Education is offered for military, EMS/first responders, and law enforcement.

Why is it important to obtain training on QuikClot® products?

Though QuikClot® products are intuitive and easy to use, training is required by many law enforcement and EMS organizations.


Usage

What are the indications for use?

QuikClot® devices are indicated as a topical dressing for the local management of bleeding wounds such as cuts, lacerations, and abrasions. They may also be used for temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, dermatological, etc.) and traumatic injuries.

Additional clearances for QuikClot® products include:

  • Temporary external use to control traumatic bleeding.
  • Local management and control of surface bleeding from vascular access sites, percutaneous catheters, or tubes utilizing introducer sheaths up to 12 Fr.
  • Local management and control of surface bleeding from vascular access sites, percutaneous catheters, or tubes utilizing introducer sheaths up to 7 Fr. in patients on drug/induced anticoagulation treatment.

What if the wound bleeds through the QuikClot® device?

More severe and traumatic wounds may require additional dressings.  In such cases, multiple QuikClot® devices may be used per the Instructions for Use.

How long can QuikClot® devices be left on the wound?

The dressings may be left on the wound site for up to 24 hours. QuikClot® devices are nonabsorbable and indicated for external use only. 

How easy are QuikClot® devices to remove?

QuikClot® devices are easy to remove. If the dressing is adhered to the wound, hydrate prior to removal. Gently remove the dressing from the wound and thoroughly irrigate. 

Do QuikClot® products have an expiration date?

Every QuikClot® device has an expiration date stamped on the package. Always refer to the expiration date and do not use products that are expired.

How should QuikClot® devices be stored?

Many QuikClot® devices were designed to withstand a variety of environments. EMS/first responder, law enforcement, and military products can withstand high temperatures and high humidity, as well as below freezing temperatures. Hospital products are packaged differently to allow aseptic handling and should be stored at temperatures of 77°F (25°C) or less. It is advised that all products be stored in a dry location, out of direct sunlight, and not in direct contact with heat sources.

Storage instructions may differ between products. Always follow the directions on the label of the product you are using.

Can I save an unused portion of a QuikClot® device for later use?

No. QuikClot® devices are single-use only.

References: 1. Trabattoni D, Montorsi P, Fabbiocchi F, Lualdi A, Gatto P, Bartorelli A. A new kaolin-based haemostatic bandage compared with manual compression for bleeding control after percutaneous coronary procedures. Eur Radiol. 2011;21:1687-1691. 2. Politi L, Aprile A, Paganelli C, et al. Randomized clinical trial on short-time compression with kaolin-filled pad: a new strategy to avoid early bleeding and subacute radial artery occlusion after percutaneous coronary intervention. J Interven Cardiol. 2011;24:65-72. 3. Trabattoni D, Gatto P, Bartorelli A. A new kaolin-based hemostatic bandage use after coronary diagnostic and interventional procedures. Int J Cardiol. 2012;156(1):53-54. 4. Lamb KM, Pitcher HT, Cavarocchi NC, Hirose H. Vascular site hemostasis in percutaneous extracorporeal membrane oxygenation therapy. Open Cardiovasc Thorac Surg J. 2012;5:8-10. 5. Pahari M, Moliver R, Lo D, Pinkerton D, Basadonna G. QuikClot® Interventional™ Hemostatic Bandage (QCI): a novel hemostatic agent for vascular access. Cath Lab Digest. 2010;18(1):28-30. http://www.cathlabdigest.com/articles/QuikClot®-Interventional™-Hemostatic-Bandage-QCI-A-Novel-Hemostatic-Agent-Vascular-Access. Accessed on August 10, 2014. 6. Tactical Combat Casualty Care Guidelines 2 June 2014. http://www.usaisr.amedd.army.mil/pdfs/TCCC_Guidelines_140602.pdf. Accessed March 25, 2015. 7. Margolis J. Initiation of blood coagulation by glass and related surfaces. Journal Physiol 1957;137:95-109. 8. Data on file. 9. Curry N, Hopewell S, Doree C, Hyde C, Brohi K, Stanworth S. The acute management of trauma hemorrhage: a systematic review of randomized controlled trials. Crit Care. 2011;15(2):R92. 10. Kheirabadi BS, Mace JE, Terrazas IB, et al. Safetry evaluation of new hemostatic agents, smectite granules, and kaolin covered gauze in vascular injury wound model in swine. J Trauma. 2010;68:269-278. 11. Kheirabadi BS, Scherer MR, Estep JS, Dubick MA, Holcomb JB. Determination of efficacy of new hemostatic dressing in a model of extremity arterial hemorrhage in swine. J Trauma. 2009;67:450-460. 12. Kheirabadi BS. Evaluation of topical hemostatic agents for combat wound treatment. US Army Med Dep J. 2011;25-37. 13. Dee KC, Puleo DA, Bizios R. Tissue-Biomaterial Interactions. Hoboken: Wiley & Sons, 2002. 14. Stop the Bleeding Coalition website http://www.stopthebleedingcoalition.com/get-the-facts.html. Updated: 18 July 2014. Accessed 24 February 2016. 15. Blair, J. Pete, and Schweit, Katherine W. (2014). A Study of Active Shooter Incidents, 2000 - 2013. Texas State University and Federal Bureau of Investigation, US Department of Justice, Washington D.C. 2014. 16. Kauvar DS, Lefering R, Wade CE. Impact of hemorrhage on trauma outcome: an overview of epidemiology, clinical presentations, and therapeutic considerations. J Trauma. 2006; 60:S3-S11.

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