Jun
2003

Large-dose hydroxyethyl starch 130/0.4 does not increase blood loss and transfusion requirements in coronary artery bypass surgery compared with hydroxyethyl starch 200/0.5 at recommended doses.

Kasper SM, Meinert P, Kampe S, et al.
Anesthesiology 2003;99(1):42-47.
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This is one of the largest PRCTs of colloid vs. colloid to date. It forms the basis of the new European dose limit for HES 130/0.4 at 50 mL/kg. Trials over 100 patients, with a power calculation and at least some attempt at blinding are a rare treat. The discussion is balanced and refreshing in highlighting the main weaknesses, in particular the fact that true blinding was not possible as the HES 200/0.5 group was unblinded when 33 mL/kg was given.

Some important points to note: Cardiac study in patients with EF >40% and “drugs known to affect coagulation” was an exclusion criterion. Thus, very low risk of bleeding in this group and can’t necessarily be translated directly to other surgeries. Dose limit on HES 200/0.5 means that we still don’t know what might have happened if this was given at 50 mL/kg. This design implies lack of equipoise (i.e., bias in favor of HES 130/0.4) and was drug company sponsored to achieve labelling advantage for HES 130/0.4. NO difference in volumes given intra-operatively (median HES 130/0.4, 2,500 mL vs. HES 200/0.5, 2,231 mL; p = 0.24) so differences were post-op. Default remained Gelatin, which is our standard of care. ALL patients received high dose APROTININ so strictly speaking results only apply to cardiac patients receiving high dose aprotinin. 5 out of 117 patients required renal replacement therapy (4.3%) and pre-op Creatinine >1.5mg/dL was an exclusion criterion – this is quite high.

All that said and done, a great study and further evidence to suggest that HES 130/0.4 is the starch of choice in Europe.

– Monty Mythen