Diaspirin CrossLinked Hemoglobin (DCLHb) Clinical Trial

2006-04-17: page first published. We appreciate your patience.

Follow this link for background information (links, etc.) on Emergency Research With Waiver of Informed Consent (FDA Regulations at 21 CFR 50.24)

INDA 6859 Diaspirin CrossLinked Hemoglobin (DCLHb) was sponsored by Baxter Healthcare Corporation. The full title of the trial sponsored by Baxter under INDA 6859 is The Efficacy Trial of Diaspirin Cross-Linked Hemoglobin (DCLHb) in the Treatment of Severe Traumatic Hemorrhagic Shock.

INDA 6859 Diaspirin CrossLinked Hemoglobin (DCLHb) study web site. Available from http://dclhb.er.uic.edu/. The study web site is currently available from http://web.archive.org/web/19990125085353/http://dclhb.er.uic.edu/

INDA 6859 Diaspirin CrossLinked Hemoglobin (DCLHb) Clinical Trial Community Consultation and Public Disclosure Material Submitted to FDA Docket 1995s-0158

Baxter Healthcare Corporation. CDLHb Protocol THS 95.1 Final Report. 1998-11-06. Available from http://www.circare.org/subjects/baxterdclhb_finalreport.pdf. (1)

INDA 6859 Diaspirin CrossLinked Hemoglobin (DCLHb). 1995s-0158 Sup. 17. Baxter Healthcare Corporation. Community consultation and public disclosure re: University of Louisville Hospital (Louisville, KY), Lehigh Valley Hospital (Allentown, PA), Carolinas Medical Center (Charlotte, NC), East Carolina University Medical Center (Greenville, NC), University of Illinois-Chicago (Chicago, IL). 1998-09-28. Available from http://www.fda.gov/ohrms/dockets/dockets/95s0158/95s-0158-sup0017.pdf

INDA 6859 Diaspirin CrossLinked Hemoglobin (DCLHb). 1995s-0158 Sup. 18. Baxter Healthcare Corporation. Post-study notification re: Oregon Health Sciences University (Portland, OR), University of Louisville Hospital (Louisville, KY), Vanderbilt University Medical Center (Nashville, TN), University of Pittsburgh Medical Center (Pittsburgh, PA), Methodist Hospital (Indianapolis, IN), Penn State Hershey Medical Center (Hershey, PA), Christiana Health Care Services (Newark, DE), St. Anthony Central Hospital (Denver, CO), MetroHealth Medical Center (Cleveland, OH), Allegheny University-Medical College of Pennsylvania (Philadelphia, PA). 1999-02-18. Available from http://www.fda.gov/ohrms/dockets/dockets/95s0158/95s-0158-sup0018.pdf

INDA 6859 Diaspirin CrossLinked Hemoglobin (DCLHb). 1995s-0158 Supp. 2. Baxter Healthcare Corporation. 1997-05-23. Available from (dead link) http://www.fda.gov/ohrms/dockets/dockets/95s0158/sup2toc.htm

INDA 6859 Diaspirin CrossLinked Hemoglobin (DCLHb). 1995s-0158 Supp. 3. Baxter Healthcare Corporation. Community consultation and public disclosure re: Oregon Health Sciences University (Portland, OR). 1997-05-29. Available from http://www.fda.gov/ohrms/dockets/dockets/95s0158/95s-0158-sup0003.pdf

INDA 6859 Diaspirin CrossLinked Hemoglobin (DCLHb). 1995s-0158 Supp. 4. Baxter Healthcare Corporation. Community consultation and public disclosure re: Vanderbilt University Medical Center (Nashville, TN). 1997-07-01. Available from http://www.fda.gov/ohrms/dockets/dockets/95s0158/95s-0158-sup0004.pdf

INDA 6859 Diaspirin CrossLinked Hemoglobin (DCLHb). 1995s-0158 Supp. 5. Baxter Healthcare Corporation. Community consultation and public disclosure re: Methodist Hospital (Indianapolis, IN), Lehigh Valley Hospital (Allentown, PA), Washington Medical (Washington, D.C.). 1997-07-17. Available from http://www.fda.gov/ohrms/dockets/dockets/95s0158/95s-0158-sup0005.pdf

INDA 6859 Diaspirin CrossLinked Hemoglobin (DCLHb). 1995s-0158 Supp. 6. Baxter Healthcare Corporation. Community consultation and public disclosure re: Parkland Memorial Hospital (Dallas, TX). 1997-08-05. Available from http://www.fda.gov/ohrms/dockets/dockets/95s0158/95s-0158-sup0006.pdf

INDA 6859 Diaspirin CrossLinked Hemoglobin (DCLHb). 1995s-0158 Supp. 7. Baxter Healthcare Corporation. Community consultation and public disclosure re: R.A. Cowley Shock Trauma Center (Baltimore, MD), Allegheny University of Health Sciences (Philadelphia, PA), Memorial Medical Center Inc. (Savannah, GA), Richland Memorial Hospital (Columbia, SC), Lehigh Valley Hospital (Allentown, PA). 1997-09-15. Available from http://www.fda.gov/ohrms/dockets/dockets/95s0158/95s-0158-sup0007.pdf

INDA 6859 Diaspirin CrossLinked Hemoglobin (DCLHb). 1995s-0158 Supp. 12. Baxter Healthcare Corporation. Community consultation and public disclosure re: St. Anthony Central Hospital (Denver, CO), University of Louisville Hospital (Louisville, KY), University of Pittsburgh Medical Center (Pittsburgh, PA), Penn State Hershey Medical Center (Hershey, PA). 1997-10-10. Available from http://www.fda.gov/ohrms/dockets/dockets/95s0158/95s-0158-sup0012.pdf

INDA 6859 Diaspirin CrossLinked Hemoglobin (DCLHb). 1995s-0158 Supp. 14. Baxter Healthcare Corporation. Community consultation and public disclosure re: Albert Einstein Medical Center (Philadelphia, PA), MetroHealth Medical Center (Cleveland, OH). 1997-11-14. Available from http://www.fda.gov/ohrms/dockets/dockets/95s0158/95s-0158-sup0014.pdf

INDA 6859 Diaspirin CrossLinked Hemoglobin (DCLHb). 1995s-0158 Supp. 15. Vol. 18. Baxter Healthcare Corporation. Community consultation and public disclosure re: Akron General Medical Center (Akron, OH), University Medical Center (Las Vegas, NV), Temple University Hospital (Philadelphia, PA), Allegheny General Hospital (Pittsburgh, PA), Penn State Hershey Medical Center (Hershey, PA). 1998-01-26. Available from http://www.fda.gov/ohrms/dockets/dockets/95s0158/95s-0158-sup0015-vol8.pdf

INDA 6859 Diaspirin CrossLinked Hemoglobin (DCLHb). 1995s-0158 Supp. 16. Vol. 19. Baxter Healthcare Corporation. 1998-02-26. Community consultation and public disclosure re: University of Cincinnati Medical Center (Cincinnati, OH), University of Illinois-Chicago (Chicago, IL). Available from http://www.fda.gov/ohrms/dockets/dockets/95s0158/95s-0158-sup0016-vol9.pdf

INDA 6859 Diaspirin CrossLinked Hemoglobin (DCLHb). 1995s-0158 Rpt. 6. Vol. 10. Baxter Healthcare Corporation. Post-study notification. 2000-04-18. Available from http://www.fda.gov/ohrms/dockets/dockets/95s0158/95s-0158-rpt0006-01toc.htm

INDA 6859 Diaspirin CrossLinked Hemoglobin (DCLHb) Clinical Trial Publications

Sloan EP, Koenigsberg M, Gens D, Cipolle M, Runge J, Mallory MN, Rodman G. Diaspirin Cross-Linked Hemoglobin (DCLHb) in the Treatment of Severe Traumatic Hemorrhagic Shock A Randomized Controlled Efficacy Trial. JAMA. 1999;282(19):1857-1864. Available from http://jama.ama-assn.org/cgi/content/full/282/19/1857 (Free registration required.)

Sloan EP, Koenigsberg M, Houghton J, Gens D, Cipolle M, Runge J, Mallory MN, Rodman G. The Informed Consent Process and the Use of the Exception to Informed Consent in the Clinical Trial of Diaspirin. Acad Emerg Med. 1999;6(12):1203-1208. Abstract available from http://www.aemj.org/cgi/content/abstract/6/12/1203

Lewis RJ, Berry DA, Cryer H, Fost N, Krome R, Washington GR, Houghton J, Blue JW, Bechhofer R, Cook T, Fisher M. 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. Annals of Emergency Medicine. 2001;38(4):397-404. Abstract available from http://dx.doi.org/10.1067/mem.2001.118223

PubMed search results for diaspirin cross-linked hemoglobin (DCLHb) in the treatment of severe traumatic hemorrhagic shock. Available from http://tinyurl.com/hyma2

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Notes

1. The 5-page file titled Baxter Healthcare Corporation. CDLHb Protocol THS 95.1 Final Report was created on 2006-03-31 from the large file posted at http://www.fda.gov/ohrms/dockets/dockets/95s0158/95s-0158-sup0018.pdf

Last Updated: 2006-04-19

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