316: Successful Hemostasis In Normal and Anti-Coagulated Hosts Using QCI, a Kaolin-Based Hemostatic Agent

Abstract

Uncontrolled hemorrhage continues to be the leading cause of death due to military trauma and the second leading cause of death in the civilian setting. Availability of efficient hemostatic agents in the emergency management of active hemorrhage,may impact significantly patients' outcome by decreasing blood loss and the overall rate of complications that are related to bleeding.This study introduces a kaolin-based hemostatic device (QCI) for bleeding control in a series of pre-clinical studies and direct human applications in both normal and anti-coagulated hosts. QCI is a non-woven rayon and polyester gauze impregnated with kaolin, an inert mineral known to activate clotting. QCI is directly derived from QuikClot Combat Gauze (Z-Medica Corporation, Wallingford, CT), which is currently the main hemostatic agent of choice for all branches of the U.S. military. Preclinical Swine Model A: Efficacy in bleeding control was studied in pigs treated either with coumadin (n=5, INR 3.2-12.4) or plavix (75 mg/day n=5) or left untreated (n=10) in a model of abdominal vascular injuries. QCI was compared to standard surgical gauze and complete bleeding control within 5 minutes was measured. The femoral artery and vein, carotid artery, and jugular vein were accessed percutaneously in pigs. After the removal of both dilators and sheaths, the QCI pad was placed over the bleeding site. Manual compression was held for 2 minutes and then a Tegaderm™ dressing was applied over the pad for an additional 3 minutes. At 5 minutes the Tegaderm™ and QCI pad were both removed and the site was evaluated for bleeding and/or hematoma formation QCI was used as an adjunct to manual compression in a total of 363 human clinical procedures (243 retrospectively and 120 prospectively as part of a clinical trial), following interventional and diagnostic cardiac catheterization in anti-coagulated patients (ACT > 200, aspirin, Plavix, low molecular weight heparin). When compared to control, standard surgical gauze, QCI was significantly more effective in achieving complete hemostasis in normal (100% complete bleeding control versus 23% within 5 minutes) and anti-coagulated animals (95% versus 24%, p <0.0001, Coumadin and 91% versus 30%, p< 0.0001, Plavix). QCI successfully controlled bleeding within 5 minutes in all preclinical cases (N=25) at the vascular access site. All 120 patients in the clinical trial clotted within 5 minutes from application and ambulated within 4 hours. Successful bleeding control within 5 minutes in 243 retrospective patients was 97.1%. This data suggests that QCI is safe and effective in controlling bleeding even in the presence of anti-coagulation following vascular access and in the various abdominal vascular injuries in both experimental animals and for routine clinical use. It is a naturally occurring mineral and does not contain any biological or botanical residue therefore avoiding possibility of allergic reaction or diseases transmission. QCI offers all the advantages of a regular surgical sponge: it is easy to use without requiring complicated training; it is pliable and can be introduced in deep cavities even through small orifices, easily reaching distant bleeding points. Prospective randomized clinical trials are currently underway to confirm these preliminary results.