In vivo effects of balanced, low molecular 6% and 10% hydroxyethyl starch compared with crystalloid volume replacement on the coagulation system in major pancreatic surgery-a sub-analysis of a prospective double-blinded, randomized controlled trial.

Background: The outcome of patients undergoing major surgery treated with HES for hemodynamic optimization is unclear. This post-hoc analysis of a randomized clinical pilot trial investigated the impact of low-molecular balanced HES solutions on the coagulation system, blood loss and transfusion requirements.
Methods: The Trial was registered: EudraCT 2008-004175-22 and ethical approval was provided by the ethics committee of Berlin. Patients were randomized into three groups receiving either a 10% HES 130/0.42 solution, a 6% HES 130/0.42 solution or a crystalloid following a goal-directed hemodynamic algorithm. Endpoints were parameters of standard and viscoelastic coagulation laboratory, blood loss and transfusion requirements at baseline, at the end of surgery (EOS) and the first postoperative day (POD 1).
Results: Fifty-two patients were included in the analysis (HES 10% (n = 15), HES 6% (n = 17) and crystalloid (n = 20)). Fibrinogen decreased in all groups at EOS (HES 10% 338 [298;378] to 192 [163;234] mg dl-1, p<0.01, HES 6% 385 [302;442] to 174 [163;224] mg dl-1, p<0.01, crystalloids 408 [325;458] to 313 [248;370] mg dl-1, p = 0.01). MCF FIBTEM was decreased for both HES groups at EOS (HES 10%: 20.5 [16.0;24.8] to 6.5 [5.0;10.8] mm, p = <0.01; HES 6% 27.0 [18.8;35.2] to 7.0 [5.0;19.0] mm, p = <0.01). These changes did not persist on POD 1 for HES 10% (rise to 16.0 [13.0;24.0] mm, p = 0.88). Blood loss was not different in the groups nor transfusion requirements.
Conclusion: Our data suggest a stronger but transient effect of balanced, low-molecular HES on the coagulation system. Despite the decline of the use of artificial colloids in clinical practice, these results may help to inform clinicians who use HES solutions.
Competing Interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: Alexander Eckers, Oliver Hunsicker and Kerstin Rubarth have declared that no competing interests exist. Claudia Spies has received research funding from B.Braun during the study DOI: 10.1097/MD.0000000000010579. Outside the submitted manuscript she has received research funding and honoraria from German Research Society (DFG), German Aerospace Center (DLR), Einstein Foundation Berlin, German Federal Joint Commitee (G-BA), Inner University grants, Project Management Agency (DLR), Stifterverband, European Society of Anaesthesiology and Intensive Care, German Federal Ministry of Economic Affairs and Climate Action, Georg Thieme Verlag, Dr. F. Köhler Chemie GmbH, Sintetica GmbH, Max-Planck-Gesellschaft zur Förderung der Wissenschaften e.V., Stifterverband für die deutsche Wissenschaft e.V./Metronic, Philips Electronics Nederland BV, BMBF/RKI, G-BA Innovationsfonds outside the submitted work. In addition, Dr. Spies has following patents licensed: 10 2014 215 211.9; 10 2018 114 364.8; 10 2018 110 275.5; 50 2015 010 534.8; 50 2015 010 347.7; 10 2014 215 212.7. Felix Balzer has received research grants from Einstein Foundation, German Federal Ministry of Education and Research, German Federal Ministry of Health, Berlin Institute of Health, Hans Böckler Stiftung, Berlin university Alliance, as well as honoraria from Medtronic, GE outside this work. Christian von Heymann has received honoraria from Artcline GmbH, CSL Behring, Daiichi Sankyo, HICC GbR, Mitsubishi Pharma, Novo Nordisk, Sobi Pharma and Shionogi Pharma that were not related to the topic of this work. This does not alter our adherence to PLOS ONE policies on sharing data and materials.
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