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J Trauma Acute Care Surg. 2014 Mar;76(3):619-23; discussion 623-4. doi: 10.1097/TA.0000000000000126.

Self-expanding foam for prehospital treatment of severe intra-abdominal hemorrhage: dose finding study.

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1
From the Division of Trauma, Emergency Surgery and Surgical Critical Care (M.S.P., J.O.H., M.J.D., J.B., G.S.V., M.A.D., D.D.Y., P.J.F., D.R.K.), Department of Surgery, Massachusetts General Hospital and Harvard Medical School, Boston; and Arsenal Medical, Inc. (A.R., J.M., G.Z., R.B., T.F., U.S.), Watertown, Massachusetts.

Abstract

BACKGROUND:

Noncompressible abdominal bleeding is a significant cause of preventable death on the battlefield and in the civilian trauma environment, with no effective therapies available at point of injury. We previously described the development of a percutaneously administered, self-expanding, poly(urea)urethane foam that improved survival in a lethal Grade V hepatic and portal vein injury model in swine. In this study, we hypothesized that survival with foam treatment is dose dependent.

METHODS:

A high-grade hepatoportal injury was created in a closed abdominal cavity, resulting in massive noncompressible hemorrhage. After injury, the animals were divided into five groups. The control group (n = 12) was treated only with fluid resuscitation, and four polymer groups received different dose volumes (Group 1, n = 6, 64 mL; Group 2, n = 6, 85 mL; Group 3, n = 18, 100 mL; and Group 4, n = 10, 120 mL) in addition to fluids. Ten minutes after injury, the foam was percutaneously administered, and animals were monitored for 3 hours.

RESULTS:

Survival with hepatoportal injury was highest in Group 4 (90%) and decreased in a dose-dependent fashion (Group 3, 72%; Group 2, 33%; Group 1, 17%). All polymer groups survived significantly longer than the controls (8.3%). Hemorrhage rate was reduced in all groups but lowest in Group 4 versus the control group (0.34 [0.052] vs. 3.0 [1.3] mL/kg/min, p < 0.001). Increasing foam dose volume was associated with increased peak intra-abdominal pressure (88.2 [38.9] in Group 4 vs. 9.5 [3.2] in the controls, p < 0.0001) and increased incidence of focal bowel injuries.

CONCLUSION:

The self-expanding foam significantly improves survival in a dose-dependent fashion in an otherwise lethal injury. Higher doses are associated with better survival but resulted in the need for bowel resection.

PMID:
24553527
DOI:
10.1097/TA.0000000000000126
[Indexed for MEDLINE]

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