Successful Hemostasis in Normal and Anti-coagulated Hosts Using Kaolin-based Agent

2.50
Hdl Handle:
http://hdl.handle.net/10755/162576
Type:
Presentation
Title:
Successful Hemostasis in Normal and Anti-coagulated Hosts Using Kaolin-based Agent
Abstract:
Successful Hemostasis in Normal and Anti-coagulated Hosts Using Kaolin-based Agent
Conference Sponsor:Emergency Nurses Association
Conference Year:2010
Author:Pahari, Mohan P., MD
P.I. Institution Name:University of Massachusetts Medical School, Dept. of Surgery
Title:Research Instructor
Contact Address:Four Biotech, Suite #304, Worcester, MA, 01605, USA
Contact Telephone:508-856-855
Co-Authors:Denny Lo; David Pinkerton; Giacomo Basadonna, MD, PhD
Leadership Conference - Research Abstract: Successful Hemostasis in Normal and Anti-coagulated Hosts Using Kaolin-based Agent.

Purpose: 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 and causes irreparable damage usually before patients reach definitive care centers. QuikClot Hemostatic Dressing (QED), a novel kaolin-coated hemostatic dressing is currently used by all branches of US Armed Forces as the first-line hemostatic treatment for life-threatening hemorrhage. This study evaluated the efficacy and safety of QED in normal and anticoagulated animals.

Design: This was a prospective randomized study in animals

Setting: This study was conducted at the University of Massachusetts medical school, Worcester, in accordance with the National Institute of health guideline for the care and use of laboratory animals.

Participants/Subjects: The adult New Zealand white rabbits (Millbrook, MA) weighing 12-15 lbs and adult Yorkshire swine weighing 50-30lbs were used for this experiment

Methods: After validating its efficacy in vitro using commercially available human plasma from anti- coagulated patients using Coumadin, in vivo study for its efficacy was studied in pigs treated either with Coumadin (n=5, INR 3.2-12.4), 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). The QED was compared to regular surgical gauze and complete bleeding control within 5 minutes was ascertained. A modified version of QED was also tested in a model of percutaneous access of femoral vessels (n=47). 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 uniform liver injury was made and the bleeding was treated with the QED and light pressure was applied until the bleeding was controlled. In Group two, the standard control surgical gauze was used, and electrocautery and/or suturing were also used to obtain hemostasis when necessary. Once bleeding was controlled, the hemostatic agents were left in place for a total of 3 hours to mimic maximum exposure in a patient following major surgery .QED and the control gauze were then removed and animals were further observed for an additional 10 minutes to warrant the hemostasis. Finally, the abdomen was closed in layers and animal was allowed to recover for 14 weeks. Histological blind analysis of abdominal organs was then performed.

Results/Outcomes: Safety: 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. Efficacy: 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, P <0.0001 and 91% vs. 30% Plavix, P <0.0001). QED also successfully controlled bleeding in all 47 cases of percutaneous vascular access within 5 minutes from application.

Implications/Conclusions: This study shows that QED, a novel Kaolin-coated hemostatic dressing is safe and effective in controlling bleeding in both normal and anti-coagulated host. It is a naturally occurring mineral and does not contain any biological or botanical residue therefore avoiding possibility of allergic reaction or diseases transmission. QED 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. Further evaluation in clinical trials is warranted.

Repository Posting Date:
27-Oct-2011
Date of Publication:
17-Oct-2011
Sponsors:
Emergency Nurses Association

Full metadata record

DC FieldValue Language
dc.typePresentationen_GB
dc.titleSuccessful Hemostasis in Normal and Anti-coagulated Hosts Using Kaolin-based Agenten_GB
dc.identifier.urihttp://hdl.handle.net/10755/162576-
dc.description.abstract<table><tr><td colspan="2" class="item-title">Successful Hemostasis in Normal and Anti-coagulated Hosts Using Kaolin-based Agent</td></tr><tr class="item-sponsor"><td class="label">Conference Sponsor:</td><td class="value">Emergency Nurses Association</td></tr><tr class="item-year"><td class="label">Conference Year:</td><td class="value">2010</td></tr><tr class="item-author"><td class="label">Author:</td><td class="value">Pahari, Mohan P., MD</td></tr><tr class="item-institute"><td class="label">P.I. Institution Name:</td><td class="value">University of Massachusetts Medical School, Dept. of Surgery</td></tr><tr class="item-author-title"><td class="label">Title:</td><td class="value">Research Instructor</td></tr><tr class="item-address"><td class="label">Contact Address:</td><td class="value">Four Biotech, Suite #304, Worcester, MA, 01605, USA</td></tr><tr class="item-phone"><td class="label">Contact Telephone:</td><td class="value">508-856-855</td></tr><tr class="item-email"><td class="label">Email:</td><td class="value">mohan.pahari@umassmed.edu</td></tr><tr class="item-co-authors"><td class="label">Co-Authors:</td><td class="value">Denny Lo; David Pinkerton; Giacomo Basadonna, MD, PhD</td></tr><tr><td colspan="2" class="item-abstract">Leadership Conference - Research Abstract: Successful Hemostasis in Normal and Anti-coagulated Hosts Using Kaolin-based Agent.<br/><br/>Purpose: 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 and causes irreparable damage usually before patients reach definitive care centers. QuikClot Hemostatic Dressing (QED), a novel kaolin-coated hemostatic dressing is currently used by all branches of US Armed Forces as the first-line hemostatic treatment for life-threatening hemorrhage. This study evaluated the efficacy and safety of QED in normal and anticoagulated animals. <br/><br/>Design: This was a prospective randomized study in animals<br/><br/>Setting: This study was conducted at the University of Massachusetts medical school, Worcester, in accordance with the National Institute of health guideline for the care and use of laboratory animals.<br/> <br/>Participants/Subjects: The adult New Zealand white rabbits (Millbrook, MA) weighing 12-15 lbs and adult Yorkshire swine weighing 50-30lbs were used for this experiment<br/><br/>Methods: After validating its efficacy in vitro using commercially available human plasma from anti- coagulated patients using Coumadin, in vivo study for its efficacy was studied in pigs treated either with Coumadin (n=5, INR 3.2-12.4), 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). The QED was compared to regular surgical gauze and complete bleeding control within 5 minutes was ascertained. A modified version of QED was also tested in a model of percutaneous access of femoral vessels (n=47). 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 uniform liver injury was made and the bleeding was treated with the QED and light pressure was applied until the bleeding was controlled. In Group two, the standard control surgical gauze was used, and electrocautery and/or suturing were also used to obtain hemostasis when necessary. Once bleeding was controlled, the hemostatic agents were left in place for a total of 3 hours to mimic maximum exposure in a patient following major surgery .QED and the control gauze were then removed and animals were further observed for an additional 10 minutes to warrant the hemostasis. Finally, the abdomen was closed in layers and animal was allowed to recover for 14 weeks. Histological blind analysis of abdominal organs was then performed.<br/><br/>Results/Outcomes: Safety: 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. Efficacy: 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, P &lt;0.0001 and 91% vs. 30% Plavix, P &lt;0.0001). QED also successfully controlled bleeding in all 47 cases of percutaneous vascular access within 5 minutes from application. <br/><br/>Implications/Conclusions: This study shows that QED, a novel Kaolin-coated hemostatic dressing is safe and effective in controlling bleeding in both normal and anti-coagulated host. It is a naturally occurring mineral and does not contain any biological or botanical residue therefore avoiding possibility of allergic reaction or diseases transmission. QED 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. Further evaluation in clinical trials is warranted.<br/><br/></td></tr></table>en_GB
dc.date.available2011-10-27T10:30:31Z-
dc.date.issued2011-10-17en_GB
dc.date.accessioned2011-10-27T10:30:31Z-
dc.description.sponsorshipEmergency Nurses Associationen_GB
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