Hemoglobin-based blood substitutes and risk of myocardial infarction and death [3]

JAMA

Volumn 300, Issue 11, 2008, Pages 1296-

  Lewis, Roger J ^a   Fost, Norman ^b  

^a HARBOR UCLA MEDICAL CENTER   (United States)

^b UNIVERSITY OF WISCONSIN SCHOOL OF MEDICINE AND PUBLIC HEALTH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTIFICIAL BLOOD; DIASPIRIN CROSSLINKED HEMOGLOBIN; HEMOGLOBIN;

DRUG INDUSTRY; DRUG MONITORING; DRUG SURVEILLANCE PROGRAM; DRUG WITHDRAWAL; LETTER; PRIORITY JOURNAL; PUBLICATION; RISK ASSESSMENT; TREATMENT FAILURE; TREATMENT WITHDRAWAL;

EID: 51949090849     PISSN: 00987484     EISSN: 15383598     Source Type: Journal    
DOI: 10.1001/jama.300.11.1296-a     Document Type: Letter

References (5)

1. Lewis RJ, Berry DA, Cryer H, et al. Monitoring a clinical trial conducted under the Food and Drug Administration regulations allowing a waiver of prospective informed consent: the diaspirin cross-linked hemoglobin traumatic hemorrhagic shock efficacy trial. Ann Emerg Med. 2001;38(4):397-404.
2. Sloan EP, Koenigsberg M, Gens D, et al. Diaspirin cross-linked hemoglobin (DCLHb) in the treatment of severe traumatic hemorrhagic shock. JAMA. 1999; 282(19):1857-1864.
3. Natanson C, Kern SJ, Lurie P, Banks SM, Wolfe SM. Cell-free hemoglobinbased blood substitutes and risk of myocardial infarction and death: a meta-analysis. JAMA. 2008;299(19):2304-2312.
4. Docket number 95s-0158 [page 40]. US Food and Drug Administration Web site. http://www.fda.gov/ohrms/dockets/DOCKETS/95s0158/95s-0158-sup0017.pdf. Accessed May 25, 2008.
5. Kerner T, Ahlers O, Veit S, et al. DCL-Hb for trauma patients with severe hemorrhagic shock: the European "On-Scene" multicenter study. Intensive Care Med. 2003;29(3):378-385.