Product name | |||
---|---|---|---|
Details | PolyHeme® | Hemopure® (HBOC-201) | HemoLink™ (Hb-raffimer) |
Company | Northfield Laboratories (Evanston, IL, USA) | Biopure Corporation (Cambridge, MA, USA) | Hemosol Inc. (Ontario, Canada) |
Indicated use | Trauma/urgent surgery | Cardiac surgery | Coronary artery bypass graft |
Clinical trial status | Phase III | Phase III | Phase II/III |
Study design | Multicenter, randomized, double blind | Multicenter, randomized, double blind | Multicenter, randomized, single blind |
End-point | Mortality | Transfusion avoidance | Transfusion avoidance |
Major findings | PolyHeme increased survival | Hemopure reduced allogeneic red cell transfusion | HemoLink reduced allogeneic red cell transfusion |
Current status | Phase III mortality study | Filed BLA | Clinical study suspended pending further analysis |
Reference | Gould and coworkers [11] | Levy and coworkers [12] | Hill and coworkers [19] |