Observational study on the influence of argatroban on coagulation factor tests under field conditions

Recruiting

Conditions: Argatroban administration in patients with heparin-induced thrombocytopenia type II (HIT II) for parenteral antithrombotic therapy.
D69.53

Registration Number: DRKS00000089

Lead Sponsor: pharmazentrum frankfurtInstitut für Klinische PharmakologieKlinikum der Johann Wolfgang Goethe-Universität Frankfurt am Main

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 120

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

Contraindications according german SmPC:
1.) uncontrollable bleedings
2.) hypersensitivity to Argatroban or any of its components
3.) severe hepatic impairment

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Determination and evaluation of further coagulation parameters, partly not routinely used during argatroban administration:<br>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. <br>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).<br>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).