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© 2001 International Anesthesia Research Society
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Abstract |
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A new hydroxyethyl starch (HES) preparation with a mean molecular weight of 130,000 daltons and a degree of substitution of 0.4 shows favorable pharmacokinetic properties. We conducted a study of the influence of the new HES specification on coagulation and compared it with another colloidal intravascular volume replacement regimen using gelatin. According to a prospective, random sequence, 42 patients undergoing major abdominal surgery received either HES 130/0.4 (n = 21) or gelatin (n = 21) until the first postoperative day (POD) to keep central venous pressure between 10 and 14 mm Hg. From arterial blood samples, standard coagulation variables were measured, and modified thrombelastogram (TEG®) measurements using different activators were performed. A total of 2830 ± 350 mL of gelatin and 2430 ± 310 mL of HES 130/0.4 were administered until the morning of the first POD. The use of allogeneic blood/blood products and standard coagulation variables did not differ significantly between the two groups. After induction of anesthesia, all TEG® data for both groups were within normal range. Coagulation time and maximum clot firmness did not change significantly in any TEG® measurements during the study period. The kinetics of clot formation (clot formation time) significantly increased immediately after surgery, but without showing significant group differences. On the morning of the first POD, the clot formation time returned to almost normal levels, except for aprotinin-activated TEG®. We conclude that administration of moderate doses of the new HES 130/0.4 preparation in patients undergoing major abdominal surgery results in similar coagulation alterations as those after using an established gelatin-based volume-replacement regimen.
Implications: We compared the effects of infusion of a new hydroxyethyl starch preparation (6% hydroxyethyl starch; mean molecular weight 130,000 daltons; degree of substitution 0.4) on coagulation with a gelatin-based intravascular volume replacement regimen in patients undergoing major abdominal surgery. After moderate doses of hydroxyethyl starch (2430 ± 310 mL until the morning of the first postoperative day), coagulation monitoring, including modified thrombelastography, did not show impaired hemostasis.
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Introduction |
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Absolute or relative intravascular volume deficits often occur during surgery, either because of surgical bleeding or vasodilation mediated by various substances. Hypovolemia results in flow alterations that are inadequate to fulfill the nutritive role of the circulation. Thus, adequate restoration of intravascular volume is an important therapeutic maneuver in managing the surgical patient’s care (1). The choice of the ideal volume replacement strategy still poses a clinical dilemma. Aside from crystalloids, gelatins and hydroxyethyl starch (HES) preparations are commonly used colloid solutions to treat hypovolemia (2).
Gelatins have little negative influence on the coagulation process, whereas HES preparations impair hemostasis ranging from mild to life-threatening bleeding complications (3,4). A novel HES preparation, showing a lower mean molecular weight (Mw) (130,000 daltons), a lower degree of substitution (DS) (0.4), and a narrower molecular distribution profile than other available HES specifications, has been developed. Because of its improved physicochemical profile, HES 130/0.4 is eliminated more quickly than standard medium-molecular weight (200,000 daltons) or high-molecular weight (450,000 daltons) HES solutions and it does not accumulate in plasma even after multiple dosing, and intravascular volume efficacy is sufficiently preserved (5,6). Because Mw/DS has a negative impact on hemostasis (7), less influence on coagulation than with other HES specifications may be expected (8). HES 130/0.4 is already approved in some countries for the treatment of hypovolemic patients. Detailed information on the influence on hemostasis, however, is not available. This study was designed to assess the influence of the new HES 130/0.4 preparation on coagulation in patients undergoing major abdominal surgery and to compare it with a gelatin-based intravascular volume-replacement strategy.
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Methods |
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Forty-two consecutive patients undergoing elective major abdominal surgery for malignancies were included in the study, which was approved by our Ethics Committees. All patients gave their written informed consent. Cardiac insufficiency (New York Heart Association class III-IV), renal insufficiency (serum creatinine >2 mg/dL), altered liver function (aspartate amino-transferase >40 U/L, alanine aminotransferase >40 U/L), preoperative anemia (hemoglobin [Hgb] <10 g/dL), preoperative coagulation abnormalities (platelet count <100 nL-1; activated partial thromboplastin time [aPTT] >70 s; fibrinogen <2 g/dL; antithrombin III <40%), and the use of cyclooxygenase inhibitors were defined as exclusion criteria for participation in the study.
All patients received their routine medication until the morning of surgery. Premedication consisted of oral midazolam 1 h before surgery. Anesthesia was induced with thiopental (5 mg/kg) and fentanyl (3 µg/kg). Neuromuscular blockade was achieved with vecuronium (0.1 mg/kg). Anesthesia was maintained with fentanyl, isoflurane, and vecuronium, titrated according to the patients’ needs. Mechanical ventilation was performed in all patients (60% nitrous oxide in oxygen) to keep arterial oxygen saturation >95% and end expiratory carbon dioxide between 35 and 40 mm Hg. Intra- and postoperative hemodynamic monitoring included continuous measurement of electrocardiogram, arterial blood pressure, and central venous pressure. To guarantee normothermia during surgery, a rewarming cover blanket system and fluid warmers were used. The patients were managed perioperatively by anesthetists who were not involved in the study and blinded to the grouping.
Patients were randomized into two groups by using computer-generated random numbers. The first group (n = 21) received 4% gelatin (B. Braun, Melsungen, Germany) until the morning of the first postoperative day (POD), in the second group (n = 21), 6% HES 130/0.4TM (Fresensius, Bad Homburg, Germany) was administered. Both solutions are approved for treating hypovolemia. Fluid was given IV to keep central venous pressure between 10 to 14 mm Hg throughout the study period. Packed red blood cells were given when Hgb was <9 g/dL, fresh frozen plasma was administered when bleeding occurred and aPTT was >70 s, fibrinogen was <2 g/dL, or antithrombin III was <40%. To compensate fluid loss by sweating, gastric tubes, and urine output, or as a solvent for drugs (e.g., antibiotics), lactated Ringer’s solution was given. Five hundred milliliters/hour of lactated Ringer’s solution was administered routinely in all patients during surgery. After surgery, all patients were sent to the intensive care unit. Mechanical ventilation was continued when necessary until the patient was ready for tracheal extubation (stable hemodynamics, sufficient spontaneous breathing, warmed to 36°C).
From arterial blood samples, standard coagulation variables (antithrombin III, fibrinogen, platelet count, aPTT) were measured by using routine laboratory methods. Another 5 mL of citrated blood was taken for performing activated thrombelastography (TEG®) by using a four-channel TEG analyzer (roTEGTM; Nobis Diagnostics, Munich, Germany). TEG tests were performed by using an automatic pipetting system within 10 min after blood sampling by the same person. The roTEGTM system uses a different power transduction system than conventional TEG devices, which makes it less susceptible to mechanical stress, movement, and vibration (9). The following measurements were performed: Intrinsic TEG (InTEG): activation using surface activator (partial thromboplastin from rabbit brain) for monitoring the intrinsic system (factors XII, XI, IX, VIII, X, II, I platelets); Extrinsic TEG (ExTEG): activation using tissue thromboplastin (rabbit brain extract) for monitoring the extrinsic system (factors VII, X, V, II, I platelets); Heparinase TEG (HepTEG): InTEG + heparin inactivation with heparinase (2 U/mL) for detection of heparin effects; Aprotinin TEG (ApTEG): ExTEG + in vitro inhibition of fibrinolytic activity through aprotinin (aprotinin solution equals 10,000 kallikrein inhibitor units per milliliter). Compared with ExTEG results, this shows evidence of hyperfibrinolytic activity after 5 min. The roTEG analysis relies on the continuous assessment of clot firmness, allowing the determination of the onset of coagulation (coagulation time [CT]—standard TEG: reaction time [r]), kinetics of clot formation (clot formation time [CFT]—standard TEG: coagulation time [k]), and maximum clot firmness ([MCF]-standard TEG: maximal amplitude [MA]). All measurements were performed after induction of anesthesia before surgery (before colloids were administered; T0), immediately after surgery (T1), and on the morning of the first POD (T2).
The necessary number of patients in each group was determined before the study by performing a power analysis and using data of a previously published TEG study on the effects of HES 130/0.4 (10). A 50% increase in reaction time (r) after the administration of HES 130/0.4 was assumed to be the minimal clinically important difference to detect. Using the standard deviation, an 
error of 0.05 (two-sided) and type II error of 0.2, 21 patients per group were assumed to be necessary. Data were presented as mean ± SD. The random numbers table used to randomize patients was generated by using FileMaker Pro 4.0TM (FileMaker, Inc., Santa Clara, CA). Statistical analysis was performed with software package SPSS/PC+ 4.0TM (SPSS, Inc., Chicago, IL). For categoric data, 
2 analyses with Fisher’s exact tests were used, if appropriate. A nonparametric test (Wilcoxon’s ranked sum) was used for variables not normally distributed (e.g., use of blood products). Differences from baseline and between the groups were evaluated by two-way analysis of variance for repeated measures (followed by the Scheffé test). A P value < 0.05 was considered significant.
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Results |
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The two groups did not differ with regard to demographic data, surgical procedures, and outcome (Table 1). The use of allogenic blood (packed red blood cells)/blood products (fresh frozen plasma) was also without differences between the two groups (Table 1). Approximately 2000 mL of either colloid was infused until the end of surgery; total amount of colloids at the first POD was 2830 ± 350 mL gelatin and 2430 ± 310 mL HES 130. Use of crystalloids, urine output, and postoperative drainage blood loss were similar in both groups (Table 2). Hemodynamics showed a comparable course in both groups (Table 3). Degree of hemodilution (Hgb) and standard coagulation variables did not differ between the groups within the entire study period (Table 3).
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All TEG data were within normal range and without group differences at baseline (Figs. 1–3). No CT or MCF data changed significantly within the entire study period (Fig. 1–3). ExTEG-CFT increased significantly after surgery in both groups (gelatin: from 76 ± 17 s to 113 ± 25 s; HES 130: from 84 ± 18 s to 122 ± 25 s) (Fig. 1). InTEG-CFT was also significantly increased after surgery in comparison to baseline data (gelatin: from 66 ± 15 s to 108 ± 22 s; HES 130: from 70 ± 15 s to 115 ± 24 s) (Fig. 2). A similar increase after surgery was seen with the ApTEG-CFT (gelatin: from 77 ± 18 s to 119 ± 25 s; HES 130: from 80 ± 17 s to 124 ± 24 s) (Fig. 3) and the HepTEG-CFT (gelatin: from 62 ± 13 s to 89 ± 20 s; HES 130: 70 ± 12 s to 96 ± 15 s) (Fig. 4). Despite the increase, all CFT data after surgery remained within normal range and did not show significant differences between the two volume groups. Except for ApTEG-CFT, all CFT-data had returned to baseline data at the end of the study period.
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Discussion |
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We used modified TEG monitoring instead of conventional TEG because different aspects of the coagulation process can be detected earlier and better by activated TEG (11–13). We did not measure single factors of the coagulation system (e.g., von Willebrand factor [vWf]) because this has only limited importance when assessing the influence of different intravascular volume replacement regimens on the coagulation process. A single coagulation factor (e.g., vWf) may be reduced markedly without resulting in a major influence on hemostasis. Thus, TEG measurements have become an accepted measure to assess coagulation changes after intravascular volume replacement (14–16).
The major result of the present study was that moderate doses of the new HES 130/0.4 preparation did not negatively influence the coagulation process. Modified TEG monitoring using different activators of coagulation showed no negative effects in the HES 130-treated group with regard to onset of coagulation (CT [C]) and MCF. Only the kinetics of clot formation (CFT) was increased consistently after surgery in all TEG analyses. However, despite this increase, CFT in the HES 130-treated patients remained within normal range and without differences to a gelatin-based volume replacement regimen. The (slightly) increased CFT at the end of the study period using ApTEG revealed some (hyper-) fibrinolysis in both groups. Standard coagulation variables and bleeding were also comparable between the HES 130- and gelatin-treated patients.
Gelatins have been considered to be without a significant negative influence on hemostatic competence (14). In an in vitro study, however, significant inhibition of platelet aggregation by gelatin was demonstrated (17). Significant reduction in clot quality was demonstrated in an in vitro study using 3.5% polygelin and 4% succinylated gelatin (18). In a study with healthy volunteers, infusion of 1 L of gelatin resulted in a 1.7-fold increase in bleeding time, a substantial decrease in vWf/ag and ristocetin cofactor, and a significant impairment of ristocetin-induced platelet aggregation (19).
The Mw and the DS of HES are mainly responsible for the effects of the different HES solutions on hemostasis (7). Impaired hemostasis with an increased bleeding tendency has been reported with the use of HES (3,4). In most of these reports, first generation high molecular weight (HMW)-HES (Mw: 450,000 dalton, DS of 0.7 [hetastarch]) was used. This solution may induce a type I vWf-like syndrome with decreased factor VIII coagulant activity, and decreased vWf antigen and factor VIII-related ristocitin cofactor (20). HMW-HES diminished the concentrations of VIIIR/ag and VIIIR/RCo more than HES with a lower Mw. HMW-HES also resulted in the overall most pronounced impaired platelet aggregation, whereas modern MMW-HES preparations did not show the same negative effects on platelet function (21). Although some experimental studies (e.g., in vitro hemodilution model) reported considerable impairment in hemostasis (15), others in humans confirmed that modern MMW-HES preparations can be used without resulting in major bleeding problems (7,22).
The advantages of gelatin in comparison to other HES preparations have been demonstrated in some in vitro studies. Using TEG monitoring, dilution with HES 200/0.5 was associated with greater alterations than with gelatin (greater increase in CFT, decrease in clot formation rate and MA) (15,16). Information concerning the safety of the new HES preparation, especially with regard to detailed coagulation data, is limited. Using SONOCOT analysis and in vitro hemodilution, HES 130/0.4 affected the maturation process significantly less than other HES preparations (23), and it was concluded that HES 130/0.4 was preferable with regard to some aspects of clot formation and retraction. Using progressive in vitro hemodilution (30% and 60% hemodilution), Jamnicki et al. (10) studied the effects of different HES preparations (HES 200/0.5, HES 130/0.4) and saline on conventional TEG data. Thirty percent hemodilution with saline resulted in a hypercoagulability state, 60% hemodilution was associated with compromised blood coagulation. Both HES solutions affected in vitro coagulation to the same degree (r and k increased; MA and angle decreased progressively).
Extrapolation of in vitro data with data found in the clinical setting is difficult, because in vitro studies do not mimic the situation in surgery (24,25). Even after minor surgery, a hypercoagulable state is seen, whereas after complex lengthy surgery, hypocoagulability may also be present (26). In in vitro studies, these surgery-related effects are absent. Thus, clinical studies are necessary to fully evaluate the influence of the new HES solution on hemostasis. In the present study, only patients scheduled for major abdominal surgery were included, because different kinds of surgery may show varying effects on hemostasis.
We conclude that administration of moderate doses of a new HES 130/0.4 preparation in patients undergoing major abdominal surgery was not associated with negative effects on hemostasis compared with an established volume replacement strategy using gelatin. Thus, this HES solution appears to be a safe alternative plasma substitute for intravascular volume replacement in the abdominal surgical patient.
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Footnotes |
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The preparation 6% HES 130/0.4 has already been approved to treat hypovolemia. This study was not sponsored by an industrial company.
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References |
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