The difference among the European patients vs American patients is that:
The European studied standard surgery with no anticoagulation (abdominal and gynecological surgery)or very little (orthopedic surgery some get a little heparin after the surgery).
The American trial is in patients undergoing "bypass" and other heart surgeries, in many of the patients the blood is recirculated or recollected from the bleeding and need to get anticoagulant to give it back to the patients, during this procedures the plasma get loss more than the red cells, the substitution is "normal saline" and this also increase bleeding tendencies and certain percent of strokes (1% to 3%, if I remember well) is expected.
It could be that Perflubron allowed for further dilution and alteration in the percent of plasma coagulation proteins, so the bleeding.
That the control group has less bleeding even than the expected is probably due to "research benefit" because the protocols are stringent and the research patient benefit many times for the best outcome possible in the "expected range" (1% instead of 3%) if the oxygent group got the 3% (even in the expected range) still it means a 200% increase in risk, to prove this 400 patients is not enough, one needs like 40,000 (and nobody is going to do that study).
Further hypothesis:
Do not use in the patients that are receiving anticoagulants.
Decrase the dose of anticoagulants (a benefit) or maybe eliminate it completely (less possible but if so, then is a major positive).
This "quality" could improved the chances in other situations like heart attacks (to prevent further dead tissue aka infarcts) where the decrease in anticoagulant will be a benefit and the "probable" anticoagulant activity will become a plus to the improved oxygenation.
Remember that J&J wanted to do heart attacks first and blood substitution later (maybe they were right).
Even in strokes could be a help, I mean the thrombotic type, not the hemorrhagic ones.
There is hope, but it will delay and for long, look at Liquid Ventilation delays after a similar situation, is like in the 4th year after that problematic phase II study.
No wonder Harris & Harris liquidated their whole holdings about 1 to 2 month ago and leave us holding the hole of it. |
