The Effects of Hydroxyethyl Starch 130/0.4 (6%) on Blood Loss and Use of Blood Products in Major Surgery: A Pooled Analysis of Randomized Clinical Trials

Kozek-Langenecker, S.; Jungheinrich, Cornelius; Sauermann, W; Linden, Philippe Van der

doi:10.1213/ane.0b013e31817e6eac

Cited by 141 publications

(73 citation statements)

References 39 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…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: 45%

See 1 more Smart Citation

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

Schramko¹

2011

Acta Anaesthesiol Scand

View full text Add to dashboard Cite

Section: Colloids and Crystalloids After Cardiac Surgery: Coagulationsupporting

confidence: 45%

“…They had been administered both intra-and postoperatively. The recent pooled analysis of randomized trials (Kozek-Langenecker et al 2008) showed that blood loss in patients undergoing major surgery and receiving HES 130/0.4 solution was less than in patients who received HES 200/0.5.…”

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

View full text Add to dashboard Cite

“…[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

View full text Add to dashboard Cite

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.

show abstract

“…It is known that various disturbances of blood coagulation can occur depending on the dosage of non-sanguineous fluid infused. Despite the influence on coagulation of HES 130/0.4 has been significantly reduced compared to other HES preparations with regard to bleeding complications [15], the dilution of blood and plasma factors must be taken into account for any fluid therapy when large volumes (e.g. in cases of massive traumatic or surgical blood loss) are administered.…”

Section: In Patients Undergoingmentioning

confidence: 99%

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

View full text Add to dashboard Cite

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.

show abstract

The Effects of Hydroxyethyl Starch 130/0.4 (6%) on Blood Loss and Use of Blood Products in Major Surgery: A Pooled Analysis of Randomized Clinical Trials

Cited by 141 publications

References 39 publications

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

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

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

Contact Info

Product

Resources

About