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Clinical Studies

Comparison of Hemostasis Times With a Kaolin-Based Hemostatic Pad (QuikClot Radial) vs Mechanical Compression (TR Band) Following Transradial Access: A Pilot Prospective Study.

Roberts JS, Niu, J, Pastor-Cervantes JA. J Invasive Cardiol. 2017 Aug 15. [Epub ahead of print]

• ‒QuikClot® Radial™ was compared to the TR Band® in patients undergoing coronary angiography and/or percutaneous coronary intervention treated via transradial access (TRA) in this prospective study (mean dose of heparin was 7117 ± 1054 IU, mean activated clotting time was 210 ± 50 sec)
• ‒“Successful initial access-site hemostasis was achieved in all cases (100%) with use of QuikClot and failed in 5 cases (50%) with use of the TR Band (P< .001).”
• ‒“Mean compression time for hemostasis with the TR Band was 149.4 min compared with 30.7 min and 60.9 min for the 30-min and 60-min QuikClot groups, respectively.” The average recovery stay was slightly shorter in the QuikClot groups than in the TR Band group.
• ‒“No [Radial Artery Occlusions] RAOs or major complications occurred in any subject at the end of this study.”
• ‒“Use of the QuikClot Radial pad following TRA in this pilot trial significantly shortened hemostasis times when compared with the TR Band, with no increased complications noted.”

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Efficacy of Hemostatic Agents in Humans with Rotational Thromboelastometry: An in-vitro Study.

Lechner R, Helm M, Mueller M, Wille T, Friemert B. Mil Med. 2016; 181:907-912.

• ‒The efficacy of QuikClot Gauze (CG), Celox (CX), QuikClot ACS+ (ACS+), and standard gauze (SG) were compared using rotational thromboelastometry (ROTEM) with blood from eight male volunteers who had no coagulation disorders.
• ‒Clotting time, clot formation time, alpha angle, maximum clot firmness, and lysis index were all measured to quantify hemostatic efficacy of dressings that are used in the military setting. Nonactivated, intrinsically activated, extrinsically activated, and fibrin-based ROTEM were used to elucidate different mechanisms of action (e.g. the intrinsic & extrinsic pathways).
• ‒With the exception of clot lysis, “CG achieved a significant improvement in all coagulation parameters in human blood…and significantly outperformed the other hemostatic agents in CT, αᵒ, and CFT”.

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Prehospital use of hemostatic dressings by the Israel Defense Forces Medical Corps: A case series of 122 patients.

Shina A, Lipsky AM, Nadler R, Levi M, Benov A, Ran Y, Yitzhak A, Glassberg E. J Trauma Acute Care Surg. 2015; 79(4):S204-S209.

• ‒This study compiled 122 prehospital cases where QuikClot Combat Gauze® (QCG) was applied 133 times between January 2009 and September 2014 by the Israeli Defense Forces.
• ‒Injuries were penetrating (85.2%), blunt (3.3%) and combined (11.5%).
• ‒“Hemorrhage control with the hemostatic dressing was reported to be successful in 88.6% of junctional applications and in 91.9% of nonjunctional applications. These results suggest that the QCG is an effective tool for hemorrhage control in both junctional and nonjunctional injuries.”
• ‒“Of note, in five patients, successful dressing application [QuikClot] was used after tourniquet failure.”

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Hemostatic dressings in civil prehospital practice: 30 uses of QuikClot Combat Gauze.

Travers S, Lefort H, Ramdani E, Lemoine S, Jost D, Bignand M, Tourtier JP. Euro J of Emerg Med. 2016; 23(5):391-4.

• ‒This prospective study collected questionnaire data from physicians and/or nurses following 30 prehospital uses of QuikClot Combat Gauze® between June 2011 and May 2014.
• ‒“For 26/30 uses, [QuikClot Combat Gauze®] hemostatic dressing was justified by the inefficiency of other hemostasis techniques. Those 30 applications were associated with 22 complete cessations of bleeding, six decreases of bleeding, and ineffectiveness in two cases.” No side-effects were seen.
• ‒The low usage (30) was due to the study design “to use hemostatic dressing only in case of failure or inability to perform other hemostasis gestures. The results of our study have since led us to expand the use of these [QuikClot®] devices.”

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Prehospital Use of Hemostatic Bandages and Tourniquets: Translation from Military Experience to Implementation in Civilian Trauma Care.

Zietlow JM, Zietlow SP, Morris DS, Berns KS, Jenkins DH. J Spec Oper Med. 2015 Summer;15(2):48-53.

• ‒This retrospective study highlights the use of 62 QuikClot Combat Gauze® dressings in 52 patients. The injuries treated with QuikClot Combat Gauze® were 50% head and neck, 35% penetrating wounds, and 15% other mechanisms of injury.
• ‒QuikClot Combat Gauze® “was highly successful at stopping bleeding, with 59 of 62 injuries (95%) achieving hemostasis.”
• ‒The use of tourniquets and hemostatic gauze in pre-hospital civilian care is safe and highly effective, with success rates of 98.7% and 95%, respectively.” The authors note the importance of initial training and that skills are maintained at 98% in two years “despite infrequent use of only about two times per month.”

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Vascular site hemostasis in percutaneous extracorporeal membrane oxygenation therapy.

Lamb KM, Pitcher HT, Cavarocchi NC, Hirose H. Open Cardiovasc Thorac Surg J. 2012;5:8-10.

• ‒The efficacy of QuikClot Combat Gauze® (QCG) was assessed when applied to bleeding from the femoral artery or vein, internal jugular vein, tracheostomy, and gastrostomy in patients receiving percutaneous extracorporeal membrane oxygenation support.
• ‒QuikClot Combat Gauze® controlled bleeding at these sites within 24 hours, resulting in “a significant reduction in both localized bleeding complications and the need for blood transfusion.”
• ‒QuikClot Combat Gauze® “is the most cost-effective product compared to … other hemostatic products such as SURGICEL®, Gelfrom®, and SURGICEL® Fibrillar™.”

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Boston bombings: a surgical view of lessons learned from combat casualty care and the applicability to Boston's terrorist attack.

Caterson EJ, Carty MJ, Weaver MJ, Holt EF. J Craniofac Surg. 2013;24(4):1061-1067.

• ‒“Application of this kaolin-impregnated gauze helps to activate the clotting cascade and has been shown to be effective to staunch bleeding on the battlefield.”
• ‒“Tourniquets and combat gauze work quite effectively for extremity trauma.”

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A new kaolin-based hemostatic bandage use after coronary diagnostic and interventional procedures.

Trabattoni D, Gatto P, Bartorelli AL. Int J Cardiol. 2012;156(1):53-54.

• ‒QuikClot® Interventional™ (QCI) was evaluated for safety and efficacy in femoral artery closure following diagnostic or interventional procedures.
• ‒Patients treated with QCI 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.
• ‒QCI “allows for a shorter and painless hemostasis procedure.”

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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.

Politi L, Aprile A, Paganelli C, Amato A, Zoccai GB, Sgura F, Monopoli D, Rossi R, Modena MG Sangiorgi GM. J Interv Cardiol. 2011;24.1:65-72.

• ‒Following a percutaneous procedure for radial artery access, 120 patients were randomized into 3 groups: QuikClot® Interventional™ compressed for 15 minutes and standard gauze compressed for 15 minutes and 2 hours.
• ‒The study found that after 15 minutes the QuikClot® achieved hemostasis 80% of the time while the standard gauze group was successful only 10% of the time. No patients in the QuikClot® group formed radial artery occlusions (RAO) while the standard gauze groups had 5% and 10% RAO respectively.
• ‒QuikClot® “does not require a learning curve for the operator or cath lab personnel or a patient monitoring after removing at the end of 15 minutes [of] compression” which could reduce costs.

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A new kaolin-based haemostatic bandage compared with manual compression for bleeding control after percutaneous coronary procedures.

Trabattoni D, Montorsi P, Fabbiocchi F, Lualdi A, Gatto P, Bartorelli AL. Eur Radiol. 2011; 21.8: 1687-1691.

• ‒200 patients treated with aspirin, clopidogrel, LMW Heparin or warfarin received randomized treatment with QuikClot® or standard manual compression following cardiac catheterization via the femoral artery following coronary diagnostic or interventional procedures.
• ‒QuikClot® significantly reduced the mean time to hemostasis to 5.4 minutes from 25 minutes in the manual compression group.

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QuikClot® Interventional™ Hemostatic Bandage (QCI): a novel hemostatic agent for vascular access.

Pahari M, Moliver R, Lo D, Pinkerton D, Basadonna G. Cath Lab Digest. 2010; 18.1: 28-30.

• ‒Collected data on 243 clinical procedures at 15 centers that used QuikClot® Interventional™ (QCI) as an adjunct to manual compression.
• ‒QCI successfully controlled bleeding in 97.12% of procedures done including those on anticoagulated patients.
• ‒Physicians said “they were highly satisfied and would use product again.”

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Preclinical Studies

QuikClot® products are intended for use as a topical dressing for local management of bleeding wounds such as cuts, lacerations and abrasions. QuikClot products may also be used for temporary treatment of severely bleeding wounds (operative, postoperative, determological, etc.) and traumatic injuries. Some of the preclinical publications present information outside the cleared indications and are included for educational purposes only.

The Effects of Movement on Hemorrhage When QuikClot® Combat Gauze™ Is Used in a Hypothermic Hemodiluted Porcine Model.

Garcia-Blanco J, Gegel B, Burgert J, Johnson S, Johnson D. J Spec Oper Med. 2015 Spring; 15(1):57-60.

• ‒QuikClot Combat Gauze® (QCG) was compared to standard gauze in a porcine model of femoral artery and vein transection. Following the removal of 30% of the animals blood volume, hemodilution, induction of hypothermia, vessel transection and one minute of free bleeding, the wounds were packed with either QCG or standard gauze followed by petroleum gauze and standard packing materials.
• ‒After the application of pressure and observation, the extremity was moved until rebleeding occurred. QCG “was able to tolerate movements more than the control group (p< 0./0001).”
• ‒“QCG produces a robust clot that can withstand significant movement.”

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The effects of QuikClot Combat Gauze on hemorrhage control when used in a porcine model of lethal femoral injury.

Johnson D, Westbrook DM, Phelps D, Blanco J, Bentlye M, Burgert J, Gegel B. Am J Disaster Med. 2014 Fall; 9(4):309-315.

• ‒A lethal femoral artery and vein transection model was used to compare QuikClot Combat Gauze (QCG) to standard gauze pressure dressing (control).
• ‒QCG was found to be much more effective than the control:
  • - Initial success of hemorrhage control was higher for QCG
  • - "Prevention of rebleeding following both induced hypertension and large volume fluid resuscitation" was greater for QCG
  • - "Absence of rebleeding following active range of motion testing (p = 0.0001)" was better for QCG
  • - "None of the swine in the QCG group rebled. Only one animal in the control group did not rebleed.”
• ‒“QCG is an effective hemostatic agent for use in trauma management. QCG is superior in controlling hemorrhage compared to standard pressure dressings.”

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Hemostasis in a noncompressible hemorrhage model: an end-user evaluation of hemostatic agents in a proximal arterial injury.

Satterly S, Nelson D, Zwintscher N, Oguntoye M, Causey W, Theis B, Huang R, Haque M, Martin M, Bickett G, Rush RM Jr. J Surg Educ. 2013;70.2:206-211.

• ‒Celox®, ChitoGauze®, QuikClot Combat Gauze®, and HemCon®bandages were applied to arterial injuries by participants including military personnel and physicians due for deployment.
• ‒No significant difference in hemostasis was seen between the products used.
• ‒QuikClot Combat Gauze® “was reported as being "the most effective at controlling hemorrhage” and was “rated as the easiest dressing to use by the soldiers.”

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The effects of QuikClot Combat Gauze® on hemorrhage control in the presence of hemodilution and hypothermia.

Johnson D, Bates S, Nukalo S, Staub A, Hines A, Leishman T, Michael J, Sikes D, Gegel B, Burgert J. Ann Med Surg. 2014 June; 3(2):21-25.

• ‒This porcine study compared the effectiveness of QuikClot Combat Gauze® (QCG) to control gauze (standard wound packing) on hemorrhage in a hemodiluted and hypothermic model.
• ‒QCG was “more effective at hemorrhage control allowing more intravenous volume resuscitation to be administered before rebleeding compared to a standard pressure dressing.”
• ‒QCG reduced the overall hemorrhage volume compared to control gauze by an average of 92.5%, achieved successful hemostasis in 84.6% of trials vs. 30.8% for control gauze, and retained on average more than 4 times as much IV volume resuscitation as control gauze.
• ‒The author establishes ideal qualities of hemostatic agents and states that “QCG meets each one of these criteria.”

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A pilot study of the use of kaolin-impregnated gauze (Combat Gauze) for packing high-grade hepatic injuries in a hypothermic coagulopathic swine model.

Sena MJ, Douglas G, Gerlach T, Grayson JK, Pichakron KO, Zierold D. J Surg Res. 2013 Aug;183(2):704-9.

• ‒Coagulopathic animals (60% exchange transfusion with Hextend) were injured with a grade V liver injury in the left middle hepatic lobe. After 30 seconds of bleeding, Combat Gauze® or the control gauze was applied.
• ‒The abdomen was closed and animals were observed for 2 hours.
• ‒Survival in the Combat Gauze® group was higher than in the plain gauze group.
• ‒“Animals treated with Combat Gauze® maintained a higher MAP following injury…Most notably, animals in the CG group lost considerably less blood than those in the [plain gauze] group.”

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Long-term preclinical evaluation of the intracorporeal use of advanced local hemostatics in a damage-control swine model of grade IV liver injury.

Inaba K, Branco BC, Rhee P, Putty B, Okoye O, Barmparas G, Talving P, Demetriades D. J Trauma. 2013; 74.2: 538-545.

• ‒Evaluated the long-term safety and efficacy of QuikClot Combat Gauze®, Celox®, and Celox Gauze® versus standard gauze in a high-grade liver injury.
• ‒Celox® Gauze® had higher mortality at all time points, higher need for repacking at 48 hours due to rebleeding, more deaths by bleeding, and a higher incidence of deaths by small bowel obstruction than QuikClot Combat Gauze®. All animals treated with Celox® products had adhesions.
• ‒QuikClot Combat Gauze® was found to be effective and created a durable hemostasis.

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The effects of QuikClot Combat Gauze® and movement on hemorrhage control in porcine model.

Gegel B, Burgert J, Gasko J, Campbell C, Martens M, Keck J, Reynolds H, Loughren M, Johnson D. Mil Med. 2012; 177.12: 1543-1547

• ‒QuikClot Combat Gauze® (QCG) and standard packing (control) were assessed in a static and moving hemorrhage model to simulate military and civilian trauma.
• ‒QCG was found to be “statistically and clinically superior at controlling hemorrhage” over control standard packing and QuikClot Combat Gauze® "produces a more robust clot that can withstand significant movement."
• ‒QCG "is an effective hemostatic agent for use in civilian and military trauma management."

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The efficacy of QuikClot Combat Gauze in extreme physiologic conditions.

Causey MW, McVay DP, Miller S, Beekley A, Martin M. J Surg Res. 2012;177(2):301-305.

• ‒The efficacy of QuikClot Combat Gauze® was assessed in a model of severe acidosis and coagulopathy to mimic a posttraumatic environment.
• ‒QuikClot Combat Gauze® had a higher success rate in achieving hemostasis at 89% for the first and 100% for the second application than standard gauze (0% for the first and 13% for the second application).
• ‒Results indicate that QuikClot Combat Gauze® significantly outperforms standard gauze dressings in this extreme physiologic model of a vascular injury.

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Safety evaluation of new hemostatic agents, smectite granules, and kaolin-coated gauze in a vascular injury wound model in swine.

Kheirabadi BS, Mace JE, Terrazas IB, et al. J Trauma. 2010;68(2):269-278.

• ‒Kheirabadi, et al studied the safety of QuikClot Combat Gauze®, WoundStat®, and standard gauze in controlling bleeding.
• ‒WoundStat® severely injured vessels and could cause lung thrombosis.
• ‒Results indicate that QuikClot Combat Gauze® is as safe as standard gauze.

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Determination of efficacy of new hemostatic dressings in a model of extremity arterial hemorrhage in swine.

Kheirabadi BS, Scherer MR, Estep JS, Dubick MA, Holcomb JB. J Trauma. 2009;67(3):450-459.

• ‒This study evaluated the efficacy of QuikClot Combat Gauze®, TraumaStat™, Celox-D™, HemCon®, and standard gauze for traumatic injuries.
• ‒QuikClot Combat Gauze® was the most effective dressing tested and resulted in the highest survival rate.
• ‒Kheirabadi, et al found “based on these results and similar findings by our colleagues at Naval Medical Research Center, the committee has recommended replacing HC bandage with the new dressing. The new Tactical Combat Casualty Care Committee guideline recommends using CG as the first line of treatment for life-threatening hemorrhage on external wounds that is not amendable to tourniquet placement.”

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