Investigation into the possibilities of finding antidotes for the new oral anti blood clotting agents

• Conditions: blood coagulation disorders; MedDRA version: 14.1Level: HLTClassification code 10009728Term: Coagulation and bleeding analysesSystem Organ Class: 100000004848; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2013-000474-30-AT
• Lead Sponsor: Medizinische Universität Innsbruck / Univ.-Klinik für Allg. u. Chirurg. Intensivmedizin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-19
• Last Update Posted: 17 June 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

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

Study & Design

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

Primary Outcome Measures

Name	Time	Method
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:<br>? Outcome of standard coagulation tests in comparison with the drug level in the patient<br>? Factors in comparison with the type and drug level in the patient<br>? Influence of co-morbidity on the efficacy of the study drugs <br>? Differences in type of NOACS and NOPAIS and their dosage <br>? Other biological parameters ;Primary end point(s): NOACs: The difference in Thrombin Generation between samples spiked with the respective antidotes <br>NOPAIs: Mulitplate<br>;Timepoint(s) of evaluation of this end point: Visit 1: timepoint 0 hours

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Difference in the response profile of the following parameters:<br>? Correlation in outcome of the standard coagulation tests with the type and drug level in patients<br>? Correlation of the coagulation factors with the type and drug level in patients<br>? Correlation of the co-morbidity on the efficacy of the study drugs (ROTEM, ETP and platelet function tests)<br>? Difference in type of NOACs and NOPAIs and their dosage (ROTEM, ETP und platelet function tests) <br>? Other biological parameters <br>;Timepoint(s) of evaluation of this end point: Visit 1: timepoint 0 hours