Hemostatic Efficacy of Modified Amylopectin Powder in a Lethal Porcine Model of Extremity Arterial Injury
Received 3 July 2008; received in revised form 21 November 2008; accepted 9 December 2008. published online 26 March 2009.
Study objective
Rapid hemostasis is crucial in controlling severe extremity hemorrhage. Our objective is to evaluate the hemostatic efficacy of a newly modified amylopectin powder in a model of severe extremity arterial hemorrhage.
Methods
Anesthetized pigs underwent severe, reproducible femoral artery injuries. Animals were randomized (nonblinded) to either modified amylopectin powder (n=10) or standard gauze application (n=6). Each hemostatic agent was applied through a pool of blood with manual compression for 3-minute intervals until hemostasis was achieved. Fluid resuscitation was infused as necessary to reestablish a mean arterial pressure within at least 80% of the preinjury mean arterial pressure if possible. The primary measured outcome was total blood loss. Secondary endpoints were survival, time to hemostasis, resuscitation mean arterial pressure, and resuscitation volume.
Results
Pretreatment blood losses were similar in both groups. Median (absolute average deviation of the median) posttreatment blood loss was significantly less in the modified amylopectin powder group than in the gauze group, 275 (108) mL versus 1,312 (171) mL. Resuscitation mean arterial pressure at 180 minutes after injury was 68% of preinjury mean arterial pressure in the modified amylopectin powder group and undetectable in all control animals. Fluid volume required for resuscitation was 1,962 (258) mL in the modified amylopectin powder group and 2,875 (150) mL in the gauze group. Time to hemostasis was 9.0 (2.1) minutes in the modified amylopectin powder group. Hemostasis was not achieved in any animal in the gauze group. Survival was 100% in the modified amylopectin powder group, whereas no animals survived in the gauze group.
Conclusion
Modified amylopectin powder demonstrates the ability to control major vascular bleeding in a lethal arterial injury model during a 3-hour period.
aDepartment of Surgery, Division of Clinical and Outcomes Research, R. Adams Cowley Shock Trauma Center, Baltimore, MD
bDepartment of Pathology, University of Maryland School of Medicine, Baltimore, MD
Address for correspondence: Michael Kilbourne, MD, R. Adams Cowley Shock Trauma Center, 22 South Greene St T1R60, Baltimore, MD 21201; 410-328-5377, fax 410-328-7175
Author contributions: MK, JRH, and GVB conceived the study. TS and GVB obtained research funding. MK, KK, and GVB conducted all surgical procedures and data collection. MK and KK managed and analyzed the data. GVB provided statistical advice on the study design and data collection and reviewed all analyzed data. MK drafted the article. TS and GVB critically revised the article. MK takes responsibility for the paper as a whole.
Funding and support: By Annals policy, all authors are required to disclose any and all commercial, financial, and other relationships in any way related to the subject of this article, that might create any potential conflict of interest. See the Manuscript Submission Agreement in this issue for examples of specific conflicts covered by this statement. Partial funding for this study was contributed by Hemostasis, LLC, St. Paul, MN.
Publication date: Available online March 25, 2009.
ABSTRACT