The effect of the used IMPs should be investigated in critically ill patients and healthy subjects
Conditions
Interventions
Trade Name: Xarelto 10 mg
Pharmaceutical Form: Tablet
INN or Proposed INN: RIVAROXABAN
CAS Number: 366789-02-8
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Sponsors
Medizinische Universität Wien; Universitätsklinik für Klinische Pharmakologie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • ICU patients • Male or female sex, age of ?18 yrs. • Critical illness requiring admission to the ICU. • Presence of Ileus or Subileus • Need for prophylactic systemic anticoagulation due to physical conditions. • Presence of disease that is associated with elevated MP levels such as sepsis, cardiovascular disease, tumor, diabetes or hyperlipidemia. • Normal renal function (serum creatinine of ?1.3 mg/dL). • Prothrombin time of ?30%. • Thrombocyte count >80 G/L. • Written informed consent by capacitated subjects. Incapacitated subjects will be informed about their study participation after having regained full consciousness. If a legal representative has been assigned,informed consent will be obtained by this person. • Controls • Male or female sex, age = 18 yrs. • Matched by age (?3 years) and sex to ICU patients. • Presence of disease that is associated with elevated MP levels such as cardiovascular disease, tumor, diabetes or hyperlipidemia. • No medical history of coagulation disorder or thromboembolic event. • Well-controlled concomitant diseases. • Written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 64 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 64
Exclusion criteria
Exclusion criteria: a. Hereditary or acquired coagulation disorders. b. Systemic treatment with antiplatelet therapy (ASS, clopidogrel, prasugrel or others) within the previous 2 days. c. In females: pregnancy or lactation. d. Systemic treatment with heparin in the previous 12 hours before study drug administration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of Xarelto/ Pradaxa on microparticle formation in critically ill compared to age- & sex-matched subjects.;Secondary Objective: To evaluate the effects of Xarelto/ Pradaxa on fibrin formation in an ex-vivo perfusion chamber model. To evaluate the effects of Xarelto/ Pradaxa on systemic fibrin formation by assessment of the endogenous thrombin potential, thrombin coagulation time, levels of D-Dimers, prothrombin fragement 1+2, soluble sP-selectin and aPTT;Primary end point(s): Plasma Microparticle concentrations;Timepoint(s) of evaluation of this end point: baseline, 3, 6 and 10hrs after IMP adminstration | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Thrombus size (D-Dimer content of degraded ex-vivo thrombus) 2. Endogenous thrombin potential (ETP) 3. Human fibrin fragment F1+2, thrombin coagulation time (TCT), levels of D-Dimers, soluble sP-selectin and of activated partial thromboplastin time (aPTT). ;Timepoint(s) of evaluation of this end point: baseline, 1, 3,6 and 10hrs after IMP administration | — |
Countries
Austria
Contacts
Public ContactSecretary of the Department
Medizinische Universität Wien; Universitätsklinik für Klinische Pharmakologie
Outcome results
None listed