Our study aim is to study the pharmacokinetics and hemodynamics of three antithrombotics and two different routes of application. Pharmacokinetics and pharmacodynamics in patients after CPB may differ compared to data for other patients so far.
Conditions
Interventions
Trade Name: Orgaran
Product Name: orgaran
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Danaparoid Natrium
CAS Number: 83513-48-8
Concentration unit: anti-Xa IU anti-Xa activity In
Sponsors
Medizinische Universität Wien
Medizinische Universität Wien
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients aged 18 to 90 years Written informed consent Patients who have undergone elective cardiac surgery on cardiopulmonary bypass admitted to ICU 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Participation in another clinical trial BMI (kg/m2) > 40 or < 19 Pregnancy Patients allergic to sulfites (contained in the formulation) Active bleeding, blood dyscrasias, subacute bacterial endocarditis, recent neurosurgical procedure, or active peptic ulcer disease Patients with known hypersensitivity to one of the three antithrombotics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Our aim is to study the pharmacokinetics and pharmacodynamics of three antithrombotics and two different routes of application;Secondary Objective: Secondary outcome parameters: D-dimer, F1+2, CRP, TEG (NATEM), ETP, incidence of bleeding episodes, number of patients with “critical” anti Xa activities, percentage of patients showing HIT antibodie, duration of filter patency (in case of hemofiltration);Primary end point(s): Time course of anti Xa levels | — |
Countries
Austria
Outcome results
None listed