Influence of anticoagulants on microparticle formatio

• Conditions: The effect of the used IMPs should be investigated in critically ill patients and healthy subjects; Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]

• Registration Number: EUCTR2011-002084-20-AT
• Lead Sponsor: Medizinische Universität Wien; Universitätsklinik für Klinische Pharmakologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06-01
• Last Update Posted: 15 July 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>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 Outcome Measures

Name	Time	Method
Secondary end point(s): 1.Thrombus size (D-Dimer content of degraded ex-vivo thrombus)<br>2.Endogenous thrombin potential (ETP)<br>3.Human fibrin fragment F1+2, thrombin coagulation time (TCT), levels of D-Dimers, soluble sP-selectin and of activated partial thromboplastin time (aPTT). <br>;Timepoint(s) of evaluation of this end point: baseline, 1, 3,6 and 10hrs after IMP administration