Repetitive Large-Dose Infusion of the Novel Hydroxyethyl Starch 130/0.4 in Patients with Severe Head Injury

Neff, Thomas; Doelberg, Martin; Jungheinrich, Cornelius; Sauerland, Andrea; Spahn, Donat R.; Stocker, Reto

doi:10.1213/01.ane.0000061582.09963.fd

Cited by 167 publications

(109 citation statements)

References 22 publications

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“…Decreased FVIII activity occurs in dogs with von Willebrand disease because of the stabilizing role of vWF on circulating FVIII levels;26 therefore, one would expect decreased FVIII activity would be seen in conjunction with the decreased vWFAg and vWFCBA. Conversely, two human studies reveal that tetrastarch doses up to 50–70 mL/kg IV were administered without changes in FVIII concentration 27, 28. Although FVIII activity decreased after tetrastarch administration in the present study, it was not statistically different from 0.9% NaCl administration.…”

Section: Discussioncontrasting

confidence: 70%

Effect of Synthetic Colloid Administration on Coagulation in Healthy Dogs and Dogs with Systemic Inflammation

Gauthier

Holowaychuk

Kerr

et al. 2015

Veterinary Internal Medicne

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BackgroundSynthetic colloids are often used during fluid resuscitation and affect coagulation.ObjectiveTo compare the effects of an isotonic crystalloid and synthetic colloid on coagulation in healthy dogs and dogs with systemic inflammation.AnimalsSixteen adult purpose‐bred Beagles.MethodsRandomized, placebo‐controlled, blinded study. Dogs were randomized into one of two groups receiving fluid resuscitation with either 40 mL/kg IV 0.9% NaCl or tetrastarch after administration of lipopolysaccharide or an equal volume of placebo. After a 14‐day washout period, the study was repeated such that dogs received the opposite treatment (LPS or placebo) but the same resuscitation fluid. Blood samples were collected at 0, 1, 2, 4, and 24 hours for measurement of coagulation variables.ResultsAdministration of either fluid to healthy dogs and dogs with systemic inflammation resulted in similar increases in prothrombin time and activated clotting time. In comparison to saline administration, tetrastarch administration resulted in significantly decreased R (P = .017) in healthy dogs, as well as significantly increased activated partial thromboplastin time (P ≤ .016), CL30% (P ≤ .016), and K (P < .001) and significantly decreased platelet count (P = .019), α (P ≤ .001), MA (P < .001), and von Willebrand factor antigen (P < .001) and collagen binding activity (P ≤ .003) in both healthy dogs and dogs with systemic inflammation.Conclusions and Clinical ImportanceTetrastarch bolus administration to dogs with systemic inflammation resulted in a transient hypocoagulability characterized by a prolonged activated partial thromboplastin time, decreased clot formation speed and clot strength, and acquired type 1 von Willebrand disease.

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Section: Discussioncontrasting

confidence: 70%

Effect of Synthetic Colloid Administration on Coagulation in Healthy Dogs and Dogs with Systemic Inflammation

Gauthier

Holowaychuk

Kerr

et al. 2015

Veterinary Internal Medicne

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“…[16] Variable length of follow-up may partly explain the high heterogeneity in overall mortality. Studies comparing 6% tetrastarch to older higher molecular weight HES solutions are unsatisfactory for the assessment of relative safety or efficacy [17][18][19][20][21] compared to non-HES solutions.…”

Section: Introductionmentioning

confidence: 99%

Randomised trials of 6 % tetrastarch (hydroxyethyl starch 130/0.4 or 0.42) for severe sepsis reporting mortality: systematic review and meta-analysis

2013

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PurposeTo assess the impact of 6% tetrastarch (hydroxyethyl starch (HES) 130/0.4 and 130/0.42) in severe sepsis patients. The primary outcome measure was 90-day mortality. MethodsA structured literature search to identify prospective randomized controlled trials (RCT) in adult patients with severe sepsis receiving 6% tetrastarch (potato or waxy maize origin), as part of fluid resuscitation in comparison to other non-HES fluids after randomisation, in the critical care setting was undertaken. A systematic review and meta-analysis was performed. ResultsSix RCTs were included (n = 3033): three from 2012 (n = 2913) had a low risk of bias. Median tetrastarch exposure was 37.4 ml/kg (range 30 to 43). Ninety-day mortality was associated with tetrastarch exposure (relative risk (RR) 1.13; 95% confidence interval (CI) 1.02 to 1.25; p = 0.02) compared to crystalloid. The number needed to harm (NNH) was 28.8 (95% CI 14.6 to 942.5). Publication bias and statistical heterogeneity (I 2 = 0%) were not present. Tetrastarch exposure was also associated with renal replacement therapy (p = 0.01; NNH 15.7) and allogeneic transfusion support (p = 0.001; NNH 9.9). No difference between groups was observed for 28-day mortality, comparison with colloid as control, and for waxy maize derived tetrastarch, but power was lacking. Overall mortality was associated with tetrastarch exposure (RR 1.13; 95% CI 1.02 to 1.25; p = 0.02). ConclusionsIn our analysis, 6% tetrastarch as part of initial fluid resuscitation for severe sepsis was associated with harm, and as alternatives exist, in our view should be avoided.

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“…70 ml/kg) were infused in trauma patients during initial resuscitation. Further studies confirm the safe use of 6% HES 130/0.4 [17][18][19][20].…”

Section: In Patients Undergoingmentioning

confidence: 95%

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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Repetitive Large-Dose Infusion of the Novel Hydroxyethyl Starch 130/0.4 in Patients with Severe Head Injury

Cited by 167 publications

References 22 publications

Effect of Synthetic Colloid Administration on Coagulation in Healthy Dogs and Dogs with Systemic Inflammation

Effect of Synthetic Colloid Administration on Coagulation in Healthy Dogs and Dogs with Systemic Inflammation

Randomised trials of 6 % tetrastarch (hydroxyethyl starch 130/0.4 or 0.42) for severe sepsis reporting mortality: systematic review and meta-analysis

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

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