blood coagulation disorders MedDRA version: 14.1 Level: HLT Classification code 10009728 Term: Coagulation and bleeding analyses System Organ Class: 100000004848
Conditions
Interventions
Trade Name: ELIQUIS
Pharmaceutical Form: Tablet
Trade Name: Pradaxa
Pharmaceutical Form: Tablet
Trade Name: Efient
Pharmaceutical Form: Tablet
Trade Name: Xarelto
Pharmaceutical Form: Tablet
Trade
Sponsors
Medizinische Universität Innsbruck / Univ.-Klinik für Allg. u. Chirurg. Intensivmedizin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients: ? Patient with the clinical need for anticoagulation using NOACs or NOPAIs ? The steady state of the single drugs have already been achieved (plasma level) ? Age: 18-90 years Controls: ? Healthy patient with no clinical need for anticoagulation ? Medications that could interfere with the results of the study (e.g. Aspirin, other anticoagulants etc.) have to be completely eliminated from the proband’s body ? Age: 18-85 years 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 110 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: Patients: ? Pregnancy ? Patients who disagree to participate in the study ? Incompliant patients in taking medication (poor compliance) ) ? Concomitant medication with influence on the respective anticoagulant and/or platelet activity ? Presence of any kind of haemophilia or acquired and hereditary coagulation disorders ? Active participation in another clinical trial ? Any condition, including the presence of laboratory abnormalities, that could prevent correct interpretation of the achieved data ? Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form Probands: ? Patients who disagree to participate in the study ? Concomitant medication with influence on anticoagulant and/or platelet activity (e.g. Aspirin, other anticoagulants etc.) ? Presence of any kind of haemophilia or acquired and hereditary coagulation disorders ? Active participation in a clinical trial ? Any condition, including the presence of laboratory abnormalities, that could prevent correct interpretation of the achieved data ? Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assessment of effective reversal of new oral anticoagulants with different promising antidotes;Secondary Objective: Investigation of the differences in the response profile of the following parameters: ? Outcome of standard coagulation tests in comparison with the drug level in the patient ? Factors in comparison with the type and drug level in the patient ? Influence of co-morbidity on the efficacy of the study drugs ? Differences in type of NOACS and NOPAIS and their dosage ? Other biological parameters ;Primary end point(s): NOACs: The difference in Thrombin Generation between samples spiked with the respective antidotes NOPAIs: Mulitplate ;Timepoint(s) of evaluation of this end point: Visit 1: timepoint 0 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Difference in the response profile of the following parameters: ? Correlation in outcome of the standard coagulation tests with the type and drug level in patients ? Correlation of the coagulation factors with the type and drug level in patients ? Correlation of the co-morbidity on the efficacy of the study drugs (ROTEM, ETP and platelet function tests) ? Difference in type of NOACs and NOPAIs and their dosage (ROTEM, ETP und platelet function tests) ? Other biological parameters ;Timepoint(s) of evaluation of this end point: Visit 1: timepoint 0 hours | — |
Countries
Austria
Contacts
Public ContactProjektmanagement
Medizinische Universität Innsbruck / Univ.-Klinik für Allg. u. Chirurg. Intensivmedizin
Outcome results
None listed