Hydroxyethyl starch and bleeding

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Hydroxyethyl starch and bleeding Anders Perner Dept. of Intensive Care, Rigshospitalet University of Copenhagen Scandinavian Critical Care Trials Group Intensive Care Medicine COIs Ferring, LFB - Honoraria B Braun AG, Fresenius Kabi CSL Behring - Research funds Anders Perner HES coagulopathy Rigshospitalet - a part of Copenhagen University Hospital

Is bleeding a problem? Major surgery Trauma Severe sepsis Anders Perner HES coagulopathy Rigshospitalet - a part of Copenhagen University Hospital

Anesthesiology 2011

Critical Care 2009 Pooling data of 5 trauma registries 5,693 pts in UK, Scandinavia, US, Germany and Holland Rigshospitalet - a part of Copenhagen University Hospital

Mortality (%) 60% 40% 20% 0% 0-3 4-7 8-11 12-15 16-19 20-23 24-27 28-31 PRBCs in 24 Hours Titel/beskrivelse (Sidehoved/fod) Rigshospitalet - a part of Copenhagen University Hospital

Bleeding and risk of death in severe sepsis 6S TRIAL Haase et al ICM 2013; e-pub ICM 2013, e-pub

HES(130)-induced bleeding? Surgical patients Trauma patients General ICU patients Severe sepsis Anders Perner HES coagulopathy Rigshospitalet - a part of Copenhagen University Hospital

Meta-analyses on bleeding with HES P I Healthy volunteers Pre-operative Perioperative Trauma Sepsis HES 130 HES 200 HES 450 Generel ICU patients C Crystalloid albumin gelatine HES 200 O Blood loss, RBC transfusions, reoperation for bleed

Meta-analysis on bleeding with HES130 Kozek-Langenecker, A&A 2008 P I Healthy volunteers Pre-operative Perioperative Trauma Sepsis HES 130 HES 200 HES 450 Generel ICU patients C Crystalloid albumin gelatine HES 200 O

Meta-analysis on bleeding with HES130 Van der Linden, A&A 2013 P Healthy volunteers Pre-operative Perioperative Trauma Sepsis Generel ICU patients I HES 130 HES 200 HES 450 C Crystalloid albumin gelatine HES O Less RBC transfusions with HES130 No differences in blood loss

Meta-analysis on bleeding with HES Navickis, J Thorac Cardiovasc Surg 2012 P I Healthy volunteers Pre-operative Perioperative Trauma Sepsis Cardiac Generel ICU patients HES 130 HES 200 HES 450 C O Crystalloid albumin gelatine HES More bleeding with HES 2X risk of reoperation More blood products used

No meta-analyses on bleeding with HES130 vs crystalloid P Healthy volunteers Pre-operative Perioperative Trauma Sepsis Generel ICU patients I HES 130 HES 200 HES 450 C Crystalloid albumin gelatine HES O???

Single center, double-blinded 50 pts scheduled for ovarian resection HES130 vs balanced crystalloid intraop. Endpoints: 1. fluid volumes, 2. postop. complications, organ failure, LOS, etc. Titel/beskrivelse (Sidehoved/fod) Rigshospitalet - a part of Copenhagen University Hospital

Bleeding and RBC use during ovarian resection

Bleeding and RBC use during ovarian resection

Single center, assessor-blinded 40 pts scheduled for cystectomy HES130 vs Ringers lactate periop. Endpoints: 1. coagulation, 2. bleeding Rasmussen et al. Ann Surg 2013;e-pub

Coagulation Rasmussen et al. Ann Surg 2013;e-pub

Bleeding and RBC use during cystectomy

HES 130/0.4 vs. Saline in trauma blood products Penetrating Blunt

HES 130/0.4 vs. Saline in trauma TEG the B-HES group showed significantly greater deterioration in coagulation during resuscitation, particularly a prolonged r-time.

HES 130/0.4 vs. Saline in trauma blood products Penetrating Blunt

HES 130/0.4 vs. Saline in trauma blood products Penetrating Blunt

HES 130/0.4 vs. Saline in trauma Mortality ITT: All randomised patients 13/58 vs. 7/57 22 vs. 12% RR for mortality with HES 1.83 (0.79 4.24)

In general ICU pts No effect of HES130 vs saline on coagulation failure (platelet no.) Myburgh et al. NEJM Oct. 2012 HES130 Saline RR P

In general ICU pts Increased use of blood with HES130 vs saline Myburgh et al. NEJM Oct. 2012 Anders Perner HES coagulopathy Rigshospitalet - a part of Copenhagen University Hospital

Hb, INR and platelets in severe sepsis pts randomised to HES130 vs Ringer s Unpublished 6S TRIAL More RBCs in HES-group on days 1 and 2 More FFP in HES-group on day 2 Anders Perner HES coagulopathy Rigshospitalet - a part of Copenhagen University Hospital

Bleeding in severe sepsis pts randomised to HES130 vs Ringer s Haase et al ICM 2013; e-pub 6S TRIAL

Earlier bleeding in the HES-group 6S TRIAL Haase et al ICM 2013; e-pub P=0.001

HES solutions Affect markers of coagulation Likely increase bleeding in severe sepsis May increase bleeding in major surgery and trauma Limited data May contribute to worse outcome in trauma, cardiac surgery and severe sepsis Anders Perner HES coagulopathy Rigshospitalet - a part of Copenhagen University Hospital

anders.perner@regionh.dk

Ex vivo dilution of blood with NaCl or synthetic colloids Velosity of clot formation by TEG Fenger-Eriksen et al, BJA 2005;94:324

Meta-analysis on bleeding with HES Navickis, J Thorac Cardiovasc Surg 2012 P I Healthy volunteers Pre-operative Perioperative Trauma Sepsis Cardiac Generel ICU patients HES 130 HES 200 HES 450 C Crystalloid albumin gelatine HES 200 O No difference between HES 130 and HES 200, Very little data

Spine surgery 44 pts randomised HES130 vs. Ringer s -angle Amplitude 30 min Fibrinogen polymerization Mittermeyer M, Anesth Analg 2007; 105: 905

Spine surgery 44 pts randomised HES130 vs. Ringer s Mittermeyer M, Anesth Analg 2007; 105: 905

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