I80
Conditions
Interventions
Group 1: Blood from Patients after hip and knee replacement surgery under therapy with Apixaban and blood from healthy Adult Subjects spiked with Apixaban in vitro were measured with Rotational thromb
Sponsors
Charité Campus Virchow-Klinikum
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Healthy Adult Subjects: no preexisting coagulation disorder, no preesisting diseases, agree to participate, no intake of anticoagulant drugs within 7 days before Study paritcipation; Patients after elective Hip- or Kneereplacement receive Apixaban (Eliquis®) for thromboprophylaxis, agree to participate, no preexisting coagulation disorders, normal kidney function, no intake of anticoagulant drugs except Apixaban, agree to participate
Exclusion criteria
Exclusion criteria: Healthy Adult Subjects: Treatment as a Patient in Charite Hospital, pregnant or breastfeeding, refusal of participation, preexisting coagulation disorder, intake anticoagulant drug permanently or during the study, insufficient German language comprehension, a legal or governmental custodian, participate in a AMG trial; Patients: refusal of participation, pregnant or breastfeeding, preexisting coagulation disorder, intake anticoagulant drug permanently or during the study except Apixaban (Eliquis®), renal insuffiency, insufficient German language comprehension, a legal or governmental custodian, participate in a AMG trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary objectives: The primary study objective is the influence of several clotting factor concentrates for reversal of anticoagulation achieved with apixaban. Which antidote is the most effective? Assays that will be measured with the ROTEM during this study are: ExTEM, InTEM, FibTEM and NaTEM. How does apixaban affect parameters measured by rotational thromboelastometry (ROTEM)? Using the above named activated assays the following parameters will be measured: clotting time (CT, corresponds to the r-time in conventional TEG), clot formation time (CFT, corresponds to the k-time) and maximum clot firmness (MCF, corresponds to the maximum amplitude of conventional TEG). Additional parameters of the standard coagulation lab are PT, PT ratio, INR, aPTT, fibrinogen, specific anti Xa activity, hemogram and FVII levels. Measurements without antidote will be compared to samples of patients under apixaban treatment respectively to in vitro samples with apixaban. Furthermore, the influence of different concentrations of rFVIIa, PCC and aPCC on the above named coagulation parameters will be measured. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives: The secondary study objectives are the influence of different doses and levels of apixaban on standard coagulation tests (prothrombin time, activated partial prothrombin time (aPTT), anti-Xa-activity and fibrinogen levels, respectively the effects of reversal on these parameters. | — |
Countries
Germany
Contacts
Public ContactKatrin Schmidt
Charite-Universitätsmedizin BerlinKlinik für Anästhesiologie m.S. operative Intensivmedizin CVK/CCM
Outcome results
None listed