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Extended Evaluation of Recombinant human activated Protein C United States trial (ENHANCE US): A single-arm, phase 3B, multicenter study of Drotrecogin alfa (activated) in Severe Sepsis

by LEVY, Howard , KAR WONG , WRIGHT, Theressa J , BERNARD, Gordon R , WHEELER, Arthur P , MARGOLIS, Benjamin D , ELY, E. Wesley , SHANIES, Harvey M

in Adult / Age Factors / Aged / APACHE / Biological and medical sciences / Cause of Death / Confidence Intervals / Critical Illness / Dose-Response Relationship, Drug / Drug Administration Schedule / Female / Follow-Up Studies / Hemorrhage - chemically induced / Hemorrhage - epidemiology / Humans / Infusions, Intravenous / Male / Medical sciences / Middle Aged / Pneumology / Probability / Prospective Studies / Protein C - administration & dosage / Protein C - adverse effects / Recombinant Proteins - administration & dosage / Recombinant Proteins - adverse effects / Reference Values / Risk Assessment / Sepsis - diagnosis / Sepsis - drug therapy / Sepsis - mortality / Severity of Illness Index / Sex Factors / Single-Blind Method / Survival Analysis / Treatment Outcome / United States

2004

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Extended Evaluation of Recombinant human activated Protein C United States trial (ENHANCE US): A single-arm, phase 3B, multicenter study of Drotrecogin alfa (activated) in Severe Sepsis

by LEVY, Howard , KAR WONG , WRIGHT, Theressa J , BERNARD, Gordon R , WHEELER, Arthur P , MARGOLIS, Benjamin D , ELY, E. Wesley , SHANIES, Harvey M

2004

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Extended Evaluation of Recombinant human activated Protein C United States trial (ENHANCE US): A single-arm, phase 3B, multicenter study of Drotrecogin alfa (activated) in Severe Sepsis

by LEVY, Howard , KAR WONG , WRIGHT, Theressa J , BERNARD, Gordon R , WHEELER, Arthur P , MARGOLIS, Benjamin D , ELY, E. Wesley , SHANIES, Harvey M

2004

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Journal Article

Extended Evaluation of Recombinant human activated Protein C United States trial (ENHANCE US): A single-arm, phase 3B, multicenter study of Drotrecogin alfa (activated) in Severe Sepsis

LEVY, Howard,

KAR WONG,

WRIGHT, Theressa J,

BERNARD, Gordon R,

WHEELER, Arthur P,

MARGOLIS, Benjamin D,

ELY, E. Wesley,

SHANIES, Harvey M

2004

Overview

To gather additional 28-day all-cause mortality and safety data among adult patients with severe sepsis who were treated with drotrecogin alfa (activated). Prospective, single-arm, multicenter clinical trial. Eighty-five study sites in the United States and two in Puerto Rico. Adult patients (273 patients) with a diagnosis of severe sepsis, which was defined as a systemic inflammatory response due to acute infection and one or more sepsis-induced organ dysfunctions present for

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Publisher

American College of Chest Physicians

Subject

Adult

/ Age Factors

/ Aged

/ APACHE

/ Biological and medical sciences

/ Cause of Death

/ Confidence Intervals