Hemocompatibility testing according to ISO 10993-4: Discrimination between pyrogen- and device-induced hemostatic activation

Stang, Katharina; Krajewski, Stefanie; Neumann, Beate; Kurz, Julia; Post, Marcell; Stoppelkamp, Sandra; Fennrich, Stefan; Avci‐Adali, Meltem; Armbruster, Doris; Schlensak, Christian; Burgener, Iwan; Wendel, Hans Peter; Walker, Tobias

doi:10.1016/j.msec.2014.05.070

Cited by 39 publications

(20 citation statements)

References 28 publications

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“…The Chandler-Loop model simulates arterial flow conditions [39,40] and enables the testing of hemocompatibility of artificial materials according to ISO 10993-4 standard tests [41]. The limited hemocompatibility of polyurethane was shown by the activation of the coagulation cascade exemplified by an increase in TAT and ß-TG levels and a decrease in platelet count, whereas the complement and inflammatory systems were only slightly influenced.…”

Section: Discussionmentioning

confidence: 99%

Effect of Immobilized Antithrombin III on the Thromboresistance of Polycarbonate Urethane

et al. 2017

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The surface of foils and vascular grafts made from a thermoplastic polycarbonate urethanes (PCU) (Chronoflex AR) were chemically modified using gas plasma treatment, binding of hydrogels—(1) polyethylene glycol bisdiamine and carboxymethyl dextran (PEG-DEX) and (2) polyethyleneimine (PEI)—and immobilization of human antithrombin III (AT). Their biological impact was tested in vitro under static and dynamic conditions. Static test methods showed a significantly reduced adhesion of endothelial cells, platelets, and bacteria, compared to untreated PCU. Modified PCU grafts were circulated in a Chandler-Loop model for 90 min at 37 °C with human blood. Before and after circulation, parameters of the hemostatic system (coagulation, platelets, complement, and leukocyte activation) were analyzed. PEI-AT significantly inhibited the activation of both coagulation and platelets and prevented the activation of leukocytes and complement. In conclusion, both modifications significantly reduce coagulation activation, but only PEI-AT creates anti-bacterial and anti-thrombogenic functionality.

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Section: Discussionmentioning

confidence: 99%

Effect of Immobilized Antithrombin III on the Thromboresistance of Polycarbonate Urethane

et al. 2017

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“…The generation of fibrin threads leads to the displacement of the ball from the magnetic field. The change of position is then detected by a magnetic sensor and thereby, the CT in seconds is determined [22,23].…”

Section: Ball Coagulometermentioning

confidence: 99%

“…Both plasma concentrations serve as indirect markers for the detection of coagulation activation. The platelet marker β-TG is released from α-granules and provides information about the platelet activation [22][23][24].…”

Section: Detection Of Fpa Tat and β-Tgmentioning

confidence: 99%

Application of Piezo-Based Measuring System for Evaluation of Nucleic Acid-Based Drugs Influencing the Coagulation

Kunnakattu

Hann

Kurz

et al. 2019

Sensors

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During open-heart surgery, the status of hemostasis has to be constantly monitored to quickly and reliably detect bleeding or coagulation disorders. In this study, a novel optimized piezo-based measuring system (PIEZ) for rheological monitoring of hemostasis was established. The applicability of the PIEZ for the evaluation of nucleic acid-based drugs influencing coagulation was analyzed. Thrombin aptamers such as NU172 might be used during extracorporeal circulation (ECC) in combination with a reduced heparin concentration or for patients with heparin-induced thrombocytopenia (HIT). Therefore, the effect of the coagulation inhibiting thrombin aptamer NU172 and the abrogation by its complementary antidote sequence (AD) were investigated by this rheological PIEZ system. After the addition of different NU172 concentrations, the coagulation of fresh human blood was analyzed under static conditions and using an in vitro rotation model under dynamic conditions (simulating ECC). The clotting times (CTs) detected by PIEZ were compared to those obtained with a medical reference device, a ball coagulometer. Additionally, after the circulation of blood samples for 30 min at 37 °C, blood cell numbers, thrombin markers (thrombin-antithrombin III (TAT) and fibrinopeptide A (FPA)) and a platelet activation marker (β-thromboglobulin (β-TG)) were analyzed by enzyme-linked immunosorbent assays (ELISAs). The increase of NU172 concentration resulted in prolonged CTs, which were comparable between the reference ball coagulometer and the PIEZ, demonstrating the reliability of the new measuring system. Moreover, by looking at the slope of the linear regression of the viscous and elastic components, PIEZ also could provide information on the kinetics of the coagulation reaction. The shear viscosity at the end of the measurements (after 300 s) was indicative of clot firmness. Furthermore, the PIEZ was able to detect the abrogation of coagulation inhibition after the equimolar addition of NU172 aptamer´s AD. The obtained results showed that the established PIEZ is capable to dynamically measure the hemostasis status in whole blood and can be applied to analyze nucleic acid-based drugs influencing the coagulation.

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“…105 Lastly, pyrogenicity testing should be reinforced given that pyrogens such as lipopolysaccharides and lipoteichoic acids activate hemostasis and can be easily introduced into testing systems during manufacturing. 106,107 …”

Section: Future Perspectivesmentioning

confidence: 99%

The Quest for Nonthrombotic Surface Modifications to Achieve Hemocompatibility of Implantable Devices

Tchouta

Bonde

2015

ASAIO Journal

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The use of blood-contacting implantable devices is limited by surface-induced thrombosis, which has led to the development of thromboresistant surfaces. Multidisciplinary efforts have promoted the development of surface modifications to minimize thrombosis by targeting surface-induced coagulation. To this date, no material has been identified that remains irrevocably hemocompatible with time but many options are now available with their own limitations. Essential to this review is the understanding of some of the challenges in this field and newer opportunities for hemocompatibility research. This report will also briefly review many of the achievements in the development of hemocompatible biomaterial coating, including surface modifications against protein adsorption and platelet adhesion, biomimetism, and endothelialization.

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Hemocompatibility testing according to ISO 10993-4: Discrimination between pyrogen- and device-induced hemostatic activation

Cited by 39 publications

References 28 publications

Effect of Immobilized Antithrombin III on the Thromboresistance of Polycarbonate Urethane

Effect of Immobilized Antithrombin III on the Thromboresistance of Polycarbonate Urethane

Application of Piezo-Based Measuring System for Evaluation of Nucleic Acid-Based Drugs Influencing the Coagulation

The Quest for Nonthrombotic Surface Modifications to Achieve Hemocompatibility of Implantable Devices

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