Voluven®, a Lower Substituted Novel Hydroxyethyl Starch (HES 130/0.4), Causes Fewer Effects on Coagulation in Major Orthopedic Surgery than HES 200/0.5

Langeron, Olivier; Doelberg, Martin; Ang, Eng-Than; Bonnet, Francis; Capdevila, Xavier; Coriat, Pierre

doi:10.1097/00000539-200104000-00011

Cited by 206 publications

(106 citation statements)

References 20 publications

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“…The hemodilution effect of HES 130/0.4 associated with its mode of action was reflected by significant changes in hematological and coagulation parameters. The quick recovery of Factor VIII and vWF in adults after surgery is in line with other findings [3,11,12]. However, it is not possible to separate the effects of profound bleeding from those attributable to hemodilution in an uncontrolled trial.…”

Section: In Patients Undergoingsupporting

confidence: 78%

“…They concluded that the hemodynamic effects of 6% HES 130/0.4 were at least similar to 5% human albumin. Langeron et al (2001) [11] and Gandhi et al (2007) [12] could demonstrate equivalence of 6% HES 130/0.4 with 6% HES 200/0.5 or 6% HES 450/0.7 in volume needed to restore or maintain hemodynamics during orthopedic surgery. Vogt et al (1996) [13] compared 6% HES 200/0.5 with 5% human albumin and demonstrated similar volume needs to stabilize hemodynamics.…”

Section: In Patients Undergoingmentioning

confidence: 97%

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The Volume Effect and Safety of 6% Hydroxyethyl Starch 130/0.4 in Patients Undergoing Major Elective Surgery: An Uncontrolled, Open-Labeled, Multi-Center Study

Morioka¹,

Ozaki²,

Yamakage³

et al. 2013

OJAnes

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Purpose: The primary aim of this study was to investigate volume effect and safety of up to 50 mL/kg BW 6% hydroxyethyl starch (HES) 130/0.4 in adult and pediatric patients undergoing major elective surgery. The need to infuse human albumin may be reduced or avoided in Japan if these large doses 6% HES 130/0.4 can be infused. Methods: The study was an uncontrolled, open-labeled, multi-center trial. Fifteen adult and 5 pediatric patients undergoing major elective surgery received 6% HES 130/0.4 (Voluven ® ) with a maximum dose of 50 mL/kg from the start of surgery until 2 hours after the end of surgery according to a treatment algorithm. The primary efficacy endpoint was the volume effect of 6% HES 130/0.4 determined by the volume of saved albumin during the investigational period and the time course of hemodynamic stability in adult and pediatric patients. Safety parameters were fluid balance, hemodynamic and laboratory parameters ECG, local and systemic tolerance and adverse events. Results: Adult patients received a mean of 32.0 mL/kg of 6% HES 130/0.4. For 12 out of 15 adult patients an average amount of 1033.8 mL (18.6 mL/kg) albumin could be saved. The other 3 adult patients did not receive more than 1000 mL of HES 130/0.4. All pediatric patients received approximately 50 mL/kg of HES 130/0.4; for these patients an average amount of 39.9 mL/kg body weight albumin could be saved. The majority of adult patients, and all pediatric patients were hemodynamically stable at all 3 time points. The observed changes of the assessed laboratory parameters including hematological and coagulation parameters or in any other safety parameter determined did not reveal any safety concern related to the administration of 6% HES 130/0.4 up to doses of 50 mL/kg body weight. Conclusion: The study results indicate that 6% HES 130/0.4 has a reliable volume effect, could contribute to significant human albumin savings and was safe and well tolerated up to a maximum dose of 50 mL/kg body weight in adult and pediatric patients undergoing major elective surgery.

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Section: In Patients Undergoingsupporting

confidence: 78%

Section: In Patients Undergoingmentioning

confidence: 97%

The Volume Effect and Safety of 6% Hydroxyethyl Starch 130/0.4 in Patients Undergoing Major Elective Surgery: An Uncontrolled, Open-Labeled, Multi-Center Study

Morioka¹,

Ozaki²,

Yamakage³

et al. 2013

OJAnes

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“…Therefore, HES solutions with lower MW and a lower degree of substitution have been developed (i.e., HES 130/0.4). The coagulation disturbances caused by modern HES solutions do not seem to be related to increased postoperative bleeding after various types of major surgery (Langeron et al 2001, Kozek-Langenecker et al 2008. The present study demonstrated that the effects of HES and gelatin solutions on blood loss are similar.…”

Section: Colloids and Crystalloids After Cardiac Surgery: Coagulationsupporting

confidence: 46%

“…The first reports of negative effects of high-MW HES solutions on blood coagulation were published in 1965 (Thompson and Gadsden). The possible mechanisms have been widely studied in experimental (Hiippala 1995, Nielsen 2005 and clinical studies (Langeron et al 2001, Boldt et al 2002. Large HES molecules interfere with fibrinogen, coagulation factor VIII, and von Willebrand factor, and their negligible effect on coagulation is more than can be expected as a result of hemodilution (Omar et al 1999).…”

Section: Coagulation Effects Of Hydroxyethyl Starchesmentioning

confidence: 99%

Post‐operative volume therapy in cardiac surgery: effects on hemostatic and circulatory variables

Schramko¹

2011

Acta Anaesthesiol Scand

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“…In general, an HES solution with low molecular weight (MW) and low degree of substitution (DS) is preferred because HES solution with high MW and high DS is harder to metabolise or eliminate and thus has a prolonged adverse effect on coagulation [2,[6][7][8][9][10][11][12]. Recently, several studies of balanced salt-based HES solution with high MW and high DS (670 ⁄ 0.75; referred to as bhHES hereafter) have reported beneficial effects on coagulation [13][14][15].…”

mentioning

confidence: 99%

Coagulation and biochemical effects of balanced salt‐based high molecular weight vs saline‐based low molecular weight hydroxyethyl starch solutions during the anhepatic period of liver transplantation

Ahn¹,

Yang²,

Gwak³

et al. 2008

Anaesthesia

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SummaryThe anhepatic period of liver transplantation is generally marked by a decrease in preload, and the infusion of hydroxyethyl starch (HES) solution is often an effective way to restore volume deficits in non-anaemic patients. However, the infusion of even limited amounts of HES solution during the anhepatic period may result in a worsening coagulopathy. Moreover, lactate-containing HES solution may cause some degree of biochemical derangements in compromised recipients. Therefore, we compared two different types of HES solutions: a balanced salt-based high molecular weight HES solution (670 ⁄ 0.75; high MW group) and a saline-based low molecular weight HES solution (130 ⁄ 0.4; low MW group) with respect to coagulation and biochemical profiles. First, in an in vitro study (n = 48), thromboelastography was performed to determine the effects of two HES solutions on coagulation after diluting (11%) the recipient's blood sample with each HES solution. Second, in an in vivo study, 500 ml of one of the two 6% HES solution was administered to 74 recipients (n = 37, each group) for 30 min after starting the anhepatic period. The coagulation profiles, including thromboelastography, and biochemical profiles were measured before and 30 min after the end of infusion. Less impairment in the thromboelastography profiles and aPTT was observed in the high MW group. A higher calcium concentration and less reduction in platelet count were noted in the high MW group, but lactate accumulation was greater. In conclusion, a balanced salt-based high molecular weight HES solution is a more effective volume replacement during the anhepatic period of liver transplantation with respect to coagulation than a saline-based low molecular weight HES solution, although lactate accumulation is a possible concern. During the anhepatic period of liver transplantation, clamping and compression of large veins (i.e. inferior vena cava, portal vein) decrease venous return and often produce haemodynamic instability. In this case, infusion of hydroxyethyl starch (HES) solution is helpful in restoring circulating volume and obviates the need to infuse large amounts of rapidly extravasating crystalloid solutions in non-anaemic recipients, most of whom present with a low oncotic pressure. Other colloid alternatives, such as albumin and fresh frozen plasma, are frequently infused during liver transplantation, but are expensive, in limited supply and risk infection [1].Despite the many well-known benefits of HES solution, its use is associated with coagulopathy. The mechanisms of coagulation impairment by HES solution include dilutional coagulopathy and inhibitions of endothelial cell activation, von Willebrand factor release, platelet function, and fibrin polymerisation [2][3][4]. Although coagulopathy is typically associated with infusion of a large volume of HES solution, it may be exacerbated further even with an otherwise safe volume of HES solution (i.e. 500 ml) in liver transplantation recipients who manifest pre-operative coagulopathy [5,6].

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Voluven®, a Lower Substituted Novel Hydroxyethyl Starch (HES 130/0.4), Causes Fewer Effects on Coagulation in Major Orthopedic Surgery than HES 200/0.5

Cited by 206 publications

References 20 publications

The Volume Effect and Safety of 6% Hydroxyethyl Starch 130/0.4 in Patients Undergoing Major Elective Surgery: An Uncontrolled, Open-Labeled, Multi-Center Study

The Volume Effect and Safety of 6% Hydroxyethyl Starch 130/0.4 in Patients Undergoing Major Elective Surgery: An Uncontrolled, Open-Labeled, Multi-Center Study

Post‐operative volume therapy in cardiac surgery: effects on hemostatic and circulatory variables

Coagulation and biochemical effects of balanced salt‐based high molecular weight vs saline‐based low molecular weight hydroxyethyl starch solutions during the anhepatic period of liver transplantation

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