Proven QuikClot® Clinical Difference

Forty (40) patients treated with QuikClot Interventional following a femoral puncture achieved hemostasis in a mean time of 4.9 minutes, allowing for early ambulation at 4 hours without any incidence of re-bleeding or hematoma.  The standard of care in the country where the study was performed is ambulation at 12 hours. QuikClot Interventional demonstrated advanced clotting time, with a shorter and painless hemostasis procedure along with early ambulation.  The study concluded, “QuikClot Interventional Hemostatic Bandage obtains prompt hemostasis and allows an early, safe ambulation following coronary diagnostic and interventional procedures by femoral approach.”

*Trabattoni D, Gatto P, Bartorelli A. A new kaolin-based hemostatic bandage use after coronary diagnostic and interventional procedures. International Journal of Cardiology. 2010:10.1016/j.ijcard.2010.10.030.

STUDY 2

*Trabattoni D, Montorsi P, Fabbiocchi F, Lualdi A, Gatto P, et al. A new kaolin-based haemostatic bandage compared with manual compression for bleeding control after percutaneous coronary procedures. European Radiology. 2011:DOI: 10.1007/s00330-011-2117-3.

STUDY 3

Journal of Interventional Cardiology (Feb 2011)*
QuikClot Radial Published Clinical Study

One-hundred and twenty (120) patients underwent cardiac catheterization via radial artery approach and were divided into 3 groups: Group 1 – QuikClot Interventional was applied for 15 minutes with manual pressure, Group 2 – Gauze (control) was applied for 15 minutes with manual pressure and Group 3 – Standard of Care with Gauze was applied for 2 hours with manual pressure.  It should be noted that the study protocol was initially designed to consist of 150 patients (3 groups of 50), but the Gauze control (Group 2) was stopped at 20 patients since all patients bled profusely.

The QuikClot Interventional product, with 15 minutes of applied manual pressure, achieved hemostasis 100% of the time with 0% incidence of radial artery occlusion.  The study concluded, “…QuikClot Interventional pad utilization combined with short-time compression was significantly superior to conventional compression technique in reducing the risk of Radial Artery Occlusion (RAO) after percutaneous transradial coronary procedures.  Furthermore, the study shows that early sheath removal and short-time compression [15 minutes versus the standard of care with 2 hour compression] with QuikClot Interventional is safe and effective.”

*Politi L, 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. Journal of Interventional Cardiology. 2011:DOI: 10.1111/j.1540-8183.2010.00584.x

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STUDY 4

European Association of Percutaneous Cardiovascular Interventions Congress (May 2011)
QuikClot Radial Presented Clinical Study

Twenty-five (25) patients treated with aspirin and clopidogrel regimens underwent interventional cardiac catheterization via radial artery approach and were treated with QuikClot Radial.  The study demonstrates that QuikClot Radial is safe and effective in favoring hemostasis after only 30 minutes of radial artery compression.  All patients showed normal radial pulse following the use of QuikClot Radial without any radial artery occlusion recorded.

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STUDY 5
 

Cath Lab Digest (Jan 2010)*
QuikClot Interventional Post Market Surveillance

Eight-hundred and forty (840) patients treated with QuikClot Interventional demonstrated that QuikClot Interventional was successful in controlling bleeding within 5 minutes at the access sites in 98.2% of the patients.  The preliminary data (n=243) was published in Cath Lab Digest (Jan 2010).

*Pahari M MD, Moliver R, Lo D, Pinkerton D, Basadonna G MD PhD. QuikClot Interventional hemostatic bandage (QCI): a novel hemostatic agent for vascular access. Cath Lab Digest. 2010;18:28-29.

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STUDY 6
 

Journal of Trauma (Sept 2009)*
QuikClot Efficacy Published Pre-Clinical Study

This study evaluated the efficacy of 5 different hemostatic dressings, including QuikClot Combat Gauze (CG), HemCon (HCs), Celox (CXb), TraumaStat (TS) and Placebo Gauze (PG) and found that QuikClot Combat Gauze was by far the most effective product.  For example, at 110 minutes all animals treated with Celox (CXb) and HemCon (HCs) died, whereas all animals treated with QuikClot Combat Gauze survived.

* Kheirabadi BS, Scherer MR, Estep JS, Dubick MA, Holcomb JB, Determination of efficacy of new hemostatic dressings in a model of extremity arterial hemorrhage in swine. J Trauma. 2009:67:450-460.

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STUDY 7
 

Journal of Trauma (Feb 2010)*
QuikClot Safety Published Pre-Clinical Study

This study evaluated the safety of QuikClot Combat Gauze, Kerlix gauze (control) and WoundStat in controlling external bleeding.  The study found that in all animals treated with Kerlix gauze (control) or Combat Gauze, the vessels remained patent and local and distal thrombosis was absent.  The results show that vascular function was intact in wounds that were treated with Kerlix gauze (control) or Combat Gauze, further proving that QuikClot Combat Gauze is as safe to use as Kerlix gauze (control).

*Kheirabadi BS, Mace JE, Terrazas IB, Fedyk CG, Estep JS, Dubick MA, Blackbourne LF. Safety evaluation of new hemostatic agents, smectite granules, and kaolin-coated gauze in vascular injury wound model in swine. J Trauma. 2010;68:269-278.