90th Annual Meeting Abstracts
A Novel Hemostatic Dressing (QuikClot Hemostatic Dressing): Efficacy and Safety Evaluation in Both Normal and Anticoagulated Hosts
Mohan P Pahari1, *Denny Lo2, *Brian Herrman3, *David Pinkerton1, Giacomo Basadonna1
1University of Massachusetts Medical School, Worcester, MA;2Z-Medica Corporation, Wallingford, CT;3Z-Medica Corporation, Walligford, CT
Background: QuikClot Hemostatic Dressing (QED) , a novel kaolin-coated clotting agent, shows great efficacy in controlling bleeding and it is currently used by all branches of US Armed Forces as the first hemostatic agent of choice. In this study, we evaluated the efficacy and safety of QED in a model of vascular injury in normal and anticoagulated animals.
Methods: Efficacy 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 (control n=10) in a model of severe abdominal vascular injuries (liver, spleen, mesentery and femoral vessels). QED was compared to standard surgical gauze and complete bleeding control within 5 minutes was measured. Safety was studied in rabbits which were prospectively randomized into treatment with QED (n=10) vs. standard surgical gauze (n=10) in a model of liver injury. A large quantity of QED was used and left in the abdominal cavity for 3 hours to mimic maximum exposure in a patient following major surgery. Animals were allowed to recover for 14 weeks. Histological analysis of abdominal organs was then performed in a blind fashion.
Results: QED was significantly more effective in achieving complete hemostasis in normal (100% complete bleeding control within 5 minutes) and anti-coagulated animals than standard surgical gauze (95% vs. 24% Coumadin and 91% vs. 30% Plavix). All rabbits exposed to intra-abdominal QED survived and no abnormalities were reported following examination of peritoneal cavity, blood analysis and histological evaluation of abdominal organs.
Conclusions: This study show that QED, a novel Kaolin-coated hemostatic dressing is safe and effective in controlling bleeding in both normal and anti-coagulated (Plavix, Coumadin) hosts. Further evaluation in clinical trials is warranted.