Argatroban administration in patients with heparin-induced thrombocytopenia type II (HIT II) for parenteral antithrombotic therapy. D69.53
Conditions
Interventions
Group 1: During clinical indicated blood withdrawals additional collection of 10ml blood into a coagulation tube to perform coagulation assays as well as for determination of Argatroban-levels. Time p
Sponsors
pharmazentrum frankfurt
Institut für Klinische Pharmakologie
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt am Main
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Indication according german SmPC: 1.) patients with heparin-induced thrombocytopenia type II (HIT II), needing a parenteral anticoagulant therapy 2.) written informed consent
Exclusion criteria
Exclusion criteria: Contraindications according german SmPC: 1.) uncontrollable bleedings 2.) hypersensitivity to Argatroban or any of its components 3.) severe hepatic impairment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determination of the coagulation parameter ecarin clotting time (ECT) under routine administration of argatroban. Ecarin clotting time will be measured on an ACL6000 coagulation analyzer. Time points of samplings are not specified, the blood withdrawals are performed together with clinically indicated blood withdrawals related to Argatroban therapy (checks of aPTT). | — |
Secondary
| Measure | Time frame |
|---|---|
| Determination and evaluation of further coagulation parameters, partly not routinely used during argatroban administration: Prothrombinase-induced clotting test (PiCT), prothrombin time (PT), activated partial thromboplastin time (aPTT), all of them measured on an ACL6000 coagulation analyzer. Thrombin generation (ETP), measured on a Fluoroskan Ascent Type 374 microplate fluorometer. Dependent on the results of these tests, furthermore determination of antithrombin III, fibrinogen and D-dimer levels, measured via in the laboratory established methods. Time points of samplings are not specified, the blood withdrawals are performed together with clinically indicated blood withdrawals related to Argatroban therapy (checks of aPTT). Determination and evaluation of influencing factors independent of Argatroban on the coagulation status in the observed p patient population (e.g. hemodynamic parameters, hepatic function, provided that these parameters are routinely determined). | — |
Countries
Germany
Contacts
Public ContactSebastian Harder
pharmazentrum frankfurt Institut für Klinische Pharmakologie Klinikum der Johann Wolfgang Goethe-Universität Frankfurt am Main
Outcome results
None listed