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Related Experiment Videos

alphaalpha-crosslinked hemoglobin: was failure predicted by preclinical testing?

R M Winslow1

  • 1Sangart, Inc., San Diego, CA, USA.

Vox Sanguinis
|September 6, 2000
PubMed
Summary
This summary is machine-generated.

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Baxter Healthcare discontinued diaspirin-crosslinked hemoglobin (DCLHb) blood substitute due to unexpected control group survival in trauma trials. Increased vascular resistance likely limits its potential as a red cell substitute.

Area of Science:

  • Biomedical Engineering
  • Hematology
  • Pharmaceutical Development

Background:

  • Baxter Healthcare's diaspirin-crosslinked hemoglobin (DCLHb) was the first blood substitute to complete human trials.
  • Development spanned from 1985 to 1998, with significant investment from Baxter, US Army, NIH, and universities.
  • The project was abandoned in 1998 due to unexpected outcomes in Phase III human trials.

Purpose of the Study:

  • To analyze the reasons behind the discontinuation of DCLHb as a blood substitute.
  • To examine the published record of DCLHb development and clinical trials.
  • To identify limitations of DCLHb and suggest future directions for blood substitute research.

Main Methods:

  • Review of published scientific literature on DCLHb development and trials.

Related Experiment Videos

  • Analysis of clinical trial data, particularly Phase III pivotal trials.
  • Examination of the hemodynamic response associated with DCLHb administration.

    • Main Results:

    • Phase III trials showed unexpectedly high survival in the control group compared to the DCLHb group in a trauma setting.
    • No single reason for DCLHb failure was identified.
    • The hemodynamic response, specifically increased vascular resistance caused by alphaalphaHb, likely precludes its use as a red cell substitute.

    Conclusions:

    • DCLHb development was halted due to trial results indicating it was not a viable red cell substitute.
    • Increased vascular resistance is a critical limitation for DCLHb.
    • Future blood substitute development must address and overcome the issue of increased vascular resistance to improve clinical outcomes.