A prospective, randomized, controlled open-label trial to investigate the effects of 10mg rivaroxaban or 110mg dabigatran on microparticle formation in critically ill patients compared to age-& sex-matched subjects - MP & anticoagulants

Medizinische Universität Wien; Universitätsklinik für Klinische Pharmakologie0 个研究点开始时间: 2011年6月1日最近更新: 2013年7月15日

适应症

试验速览

暂无简介。

•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.
•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

•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.

发起方

Medizinische Universität Wien; Universitätsklinik für Klinische Pharmakologie