Matches in SemOpenAlex for { <https://semopenalex.org/work/W2728931161> ?p ?o ?g. }
Showing items 1 to 84 of
84
with 100 items per page.
- W2728931161 endingPage "350" @default.
- W2728931161 startingPage "343" @default.
- W2728931161 abstract "Historically, hemoglobin-based oxygen carriers (HBOCs) were being developed as blood substitutes, despite their transient circulatory half-life (~ 24 h) vs. transfused red blood cells (RBCs). More recently, HBOC commercial development focused on oxygen therapeutic indications to provide a temporary oxygenation bridge until medical or surgical interventions (including RBC transfusion, if required) can be initiated. This included the early trauma trials with HemAssist ® (BAXTER), Hemopure ® (BIOPURE) and PolyHeme ® (NORTHFIELD) for resuscitating hypotensive shock. These trials all failed due to safety concerns (e.g., cardiac events, mortality) and certain protocol design limitations. In 2008 the Food and Drug Administration (FDA) put all HBOC trials in the US on clinical hold due to the unfavorable benefit:risk profile demonstrated by various HBOCs in different clinical studies in a meta-analysis published by Natanson et al. (2008). During standard resuscitation in trauma, organ dysfunction and failure can occur due to ischemia in critical tissues, which can be detected by the degree of lactic acidosis. SANGART'S Phase 2 trauma program with MP4OX therefore added lactate >5 mmol/L as an inclusion criterion to enroll patients who had lost sufficient blood to cause a tissue oxygen debt. This was key to the successful conduct of their Phase 2 program (ex-US, from 2009 to 2012) to evaluate MP4OX as an adjunct to standard fluid resuscitation and transfusion of RBCs. In 2013, SANGART shared their Phase 2b results with the FDA, and succeeded in getting the FDA to agree that a planned Phase 2c higher dose comparison study of MP4OX in trauma could include clinical sites in the US. Unfortunately, SANGART failed to secure new funding and was forced to terminate development and operations in Dec 2013, even though a regulatory path forward with FDA approval to proceed in trauma had been achieved." @default.
- W2728931161 created "2017-07-14" @default.
- W2728931161 creator A5006113206 @default.
- W2728931161 date "2017-01-01" @default.
- W2728931161 modified "2023-09-25" @default.
- W2728931161 title "Hemoglobin-Based Oxygen Carrier (HBOC) Development in Trauma: Previous Regulatory Challenges, Lessons Learned, and a Path Forward" @default.
- W2728931161 cites W1596721416 @default.
- W2728931161 cites W1830967365 @default.
- W2728931161 cites W1981564073 @default.
- W2728931161 cites W1997824742 @default.
- W2728931161 cites W2007162533 @default.
- W2728931161 cites W2012660979 @default.
- W2728931161 cites W2015309476 @default.
- W2728931161 cites W2033486211 @default.
- W2728931161 cites W2040350871 @default.
- W2728931161 cites W2043662804 @default.
- W2728931161 cites W2051382343 @default.
- W2728931161 cites W2053889789 @default.
- W2728931161 cites W2067672838 @default.
- W2728931161 cites W2076038591 @default.
- W2728931161 cites W2080099365 @default.
- W2728931161 cites W2109027708 @default.
- W2728931161 cites W2151992688 @default.
- W2728931161 cites W2489138317 @default.
- W2728931161 cites W4250907312 @default.
- W2728931161 cites W94727591 @default.
- W2728931161 doi "https://doi.org/10.1007/978-3-319-55231-6_45" @default.
- W2728931161 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/28685464" @default.
- W2728931161 hasPublicationYear "2017" @default.
- W2728931161 type Work @default.
- W2728931161 sameAs 2728931161 @default.
- W2728931161 citedByCount "22" @default.
- W2728931161 countsByYear W27289311612018 @default.
- W2728931161 countsByYear W27289311612019 @default.
- W2728931161 countsByYear W27289311612020 @default.
- W2728931161 countsByYear W27289311612021 @default.
- W2728931161 countsByYear W27289311612022 @default.
- W2728931161 countsByYear W27289311612023 @default.
- W2728931161 crossrefType "book-chapter" @default.
- W2728931161 hasAuthorship W2728931161A5006113206 @default.
- W2728931161 hasConcept C126322002 @default.
- W2728931161 hasConcept C177713679 @default.
- W2728931161 hasConcept C178790620 @default.
- W2728931161 hasConcept C185592680 @default.
- W2728931161 hasConcept C2778165595 @default.
- W2728931161 hasConcept C2780317664 @default.
- W2728931161 hasConcept C2781300812 @default.
- W2728931161 hasConcept C2993864201 @default.
- W2728931161 hasConcept C42219234 @default.
- W2728931161 hasConcept C535046627 @default.
- W2728931161 hasConcept C540031477 @default.
- W2728931161 hasConcept C71924100 @default.
- W2728931161 hasConceptScore W2728931161C126322002 @default.
- W2728931161 hasConceptScore W2728931161C177713679 @default.
- W2728931161 hasConceptScore W2728931161C178790620 @default.
- W2728931161 hasConceptScore W2728931161C185592680 @default.
- W2728931161 hasConceptScore W2728931161C2778165595 @default.
- W2728931161 hasConceptScore W2728931161C2780317664 @default.
- W2728931161 hasConceptScore W2728931161C2781300812 @default.
- W2728931161 hasConceptScore W2728931161C2993864201 @default.
- W2728931161 hasConceptScore W2728931161C42219234 @default.
- W2728931161 hasConceptScore W2728931161C535046627 @default.
- W2728931161 hasConceptScore W2728931161C540031477 @default.
- W2728931161 hasConceptScore W2728931161C71924100 @default.
- W2728931161 hasLocation W27289311611 @default.
- W2728931161 hasLocation W27289311612 @default.
- W2728931161 hasOpenAccess W2728931161 @default.
- W2728931161 hasPrimaryLocation W27289311611 @default.
- W2728931161 hasRelatedWork W1964979041 @default.
- W2728931161 hasRelatedWork W1969083939 @default.
- W2728931161 hasRelatedWork W1989580161 @default.
- W2728931161 hasRelatedWork W1993502248 @default.
- W2728931161 hasRelatedWork W1999241768 @default.
- W2728931161 hasRelatedWork W2022854759 @default.
- W2728931161 hasRelatedWork W2049010575 @default.
- W2728931161 hasRelatedWork W2166998452 @default.
- W2728931161 hasRelatedWork W2276341284 @default.
- W2728931161 hasRelatedWork W228594689 @default.
- W2728931161 isParatext "false" @default.
- W2728931161 isRetracted "false" @default.
- W2728931161 magId "2728931161" @default.
- W2728931161 workType "book-chapter" @default.