Tetrastarch in cardiac surgery: error, confounding and bias in a meta-analysis of randomized trials
© Navickis et al; licensee BioMed Central. 2015
Published: 22 April 2015
In a meta-analysis of cardiac surgery trials, we showed that hydroxyethyl starch increases postoperative blood loss, blood product transfusion and reoperation for bleeding . Citing that meta-analysis, the US Food and Drug Administration determined excess bleeding to be a class effect of hydroxyethyl starch solutions and issued a safety warning .
Their finding of lower blood loss with tetrastarch than pentastarch is attributable to publication bias, since an unpublished trial with higher blood loss and more frequent reoperation for bleeding after tetrastarch was omitted [1,5]. The omitted trial had been submitted to the US Food and Drug Administration in a New Drug Application by the same tetrastarch manufacturer who commissioned the new meta-analysis. That trial was included in two previous meta-analyses [1,5].
The authors gratefully acknowledge the cooperation of Anne Kuitunen, Young Lan Kwak, Tomi Niemi and Alexey Schramko in furnishing blood loss data from their trials.
This work is solely that of the authors. No other individual or organization contributed substantially to the conception of the letter or to manuscript preparation and revision.
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