Argatroban (Argatra®) in critically ill patients, when heparin is not effective

Phase 1

Conditions: Heparin resistance in critically ill patients with the need of prophylactic anticoagulation
MedDRA version: 18.1Level: HLTClassification code 10036896Term: Prophylactic procedures NECSystem Organ Class: 100000004865
MedDRA version: 18.1Level: LLTClassification code 10036893Term: ProphylacticSystem Organ Class: 100000004865
Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Registration Number: EUCTR2012-000487-23-AT

Lead Sponsor: Medizinische Universität Innsbruck / Univ.-Klinik für Allgemeine und Chirurgische Intensivmedizin

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- Patient at risk for thrombosis or thromboembolic complications with the need of prophylactic antithrombotic therapy
- Age: 18 – 85 years
- Prohylactic anticoagulation (aPTT: 45 – 60 sec) is not achieved with a heparin dosage of 1.200 IU per hour after two hours of infusion

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 9
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 35

Exclusion Criteria

- If patient needs an aPTT-level > 60 sec for any reason
- Active bleeding
- Risk for bleeding higher than risk of thromboembolic event as anticipated by the physician
- Planned surgical procedure with the need for interruption of antithrombotic therapy within the next 24 hours
- Inevitable lethal course
- Severe Liver failure: Quick < 30 %
- Pregnancy
- Planned peridural or spinal anaesthesia during the study
- Patient with known refusal of a participation in this clinical trial
- Active participation in another clinical trial
- Any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if he/she were to participate in the study or confound the ability to interpret data from the study
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form