Coagulation disorders in surgical intensive care patients
Conditions
Interventions
Group 1: In this prospective, non-interventional observational study, surgical intensive care patients receiving anticoagulation with Argatroban as part of routine clinical care are included. Blood sa
Sponsors
Universitätsklinikum Heidelberg, Klinik für Anästhesiologie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Treatment in a surgical intensive care unit (ICU) or intermediate care unit (IMC) at Heidelberg University Hospital - Clinically indicated anticoagulation with Argatroban (suspected or confirmed heparin-induced thrombocytopenia type II (HIT II)) - Written informed consent obtained from the patient; in cases of temporary incapacity to consent, consent provided by the legal representative with subsequent confirmation by the patient once decision-making capacity has been regained
Exclusion criteria
Exclusion criteria: - Age <18 years - Refusal to participate by the patient or, in case of incapacity to consent, by the legal representative - Pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is the correlation between point-of-care measurement of Ecarin Clotting Time (ECT) and the actual plasma concentration of Argatroban in surgical intensive care patients receiving ongoing Argatroban therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Correlation between Ecarin Clotting Time and established surrogate parameters of Argatroban monitoring (activated partial thromboplastin time and diluted thrombin time): Investigation of the association between Ecarin Clotting Time and the established coagulation parameters using the measurements obtained within the study. - Determination of the Ecarin Clotting Time range corresponding to therapeutic Argatroban plasma concentrations: Identification of the Ecarin Clotting Time range associated with therapeutic Argatroban plasma concentrations and evaluation of the diagnostic performance of Ecarin Clotting Time for identifying therapeutic Argatroban plasma concentrations. - Proportion of misclassified dosing assessments by surrogate parameters (activated partial thromboplastin time, diluted thrombin time or Ecarin Clotting Time): Determination of the proportion of measurements in which a surrogate parameter is within the therapeutic target range despite the measured Argatroban plasma concentration indicating under- or overdosing, and comparison of misclassification rates between the parameters. - Association between surrogate parameters and clinical complications: Investigation of the relationship between values of the surrogate parameters (Ecarin Clotting Time, activated partial thromboplastin time, diluted thrombin time) and the occurrence of bleeding or thromboembolic complications during Argatroban therapy. | — |
Countries
Germany
Contacts
Public ContactDaniel Gruneberg
Universitätsklinikum Heidelberg, Klinik für Anästhesiologie
Outcome results
None listed