Argatroban in Critically Ill Patients With Heparin Resistance
Condition: Achievement of a Sufficient Thrombosis Prohpylaxis in Clitically Ill Patients With Heparin Resistance
MeSH terms: Thrombosis
Study type: Interventional
Phase: Phase 2

Summary: 
      Critically ill patients with high risk for thrombosis or tromboembolic events with the
      presence of heparin resistance, treated at the Department for General and Surgical Critical
      Care Medicine of the Medical University Innsbruck, Austria will be enrolled in the study when
      meeting the inclusion- and exclusion criteria. If a patient meets the inclusion criteria and
      is recruited for the study, the patient will be randomized either to Group A or Group H.

      All patients have to achieve a prophylactic aPTT-target range of an aPTT-level of 45 - 60 sec
      (Pathromtin® SL) within 6 to 8 hours.

      Randomisation Group A:

      If a Heparin resistance appears and the patient meets the inclusion and exclu-sion criteria,
      he/she will be enrolled. The Heparin administration will be stopped and Argatroban will be
      given and adjusted until the target aPTT-range is achieved.

      Randomisation Group H - Standard therapy:

      If a Heparin resistance appears and the patient meets the inclusion and exclu-sion criteria,
      he/she will be enrolled. The Heparin administration will be contin-ued and, if necessary
      increased. Hereby the maximum heparin dose is 1.500 IU per hour.

      Therapy failure Group H:

      Primary target failure at Visit 3 (6-8 hours):

      If a patient of Group H does not achieve the target-aPTT within 6-8 hours, he/she will switch
      to Group A and will start with T1 (Baseline) and will follow the visits according to Group A
      until the final Visit 9 (T1 / day 30).

      Maintenance failure after Visit 3:

      Maintenance failure after 6-8 hours is defined as non-maintenance of the tar-get-aPTT until
      day 7 with a max. heparin dosage of 1.500 IU per hour. In this case, heparin therapy has to
      be changed to Argatroban.

      The patient will start with T1 (Baseline) and will follow the visits according to Group A
      until the final Visit 9 (day 30) counting from the Baseline of Group A.

      Therapy failure Group A:

      If a patient of Group A does not achieve the target-aPTT within 6-8 hours or cannot maintain
      the target-aPTT in spite of reaching the maximum dosage of 10µg/kg/min during the further
      study period, the patient automatically drops out of the study.

      The same is effective for patients who switched to the Group A after a therapy failure in
      Group H.

      General:

      Two hours after starting the Baseline investigations, patient's parameters in-cluding blood
      collections will be measured for the second time (T2). Additional measurements will be made
      at 6-8 hours (T3), 24 hours (T4), 48 hours (T5), 5 days (T6) after start of study drug and on
      day 7 before (T7) stop of study medication and 6h (T8) after stop of study medication. 30
      days after inclusion in the study, a final investigation is planned (T9).
    


Intervention name(s): Argatroban
Intervention type(s): Drug
Intervention description(s): Start: Argatroban dose is 0.05 µg/kg/min (patients with hepatic impairment, after cardiac surgery) until maximum: 10 µg/kg/min
Intervention MeSH terms: Argatroban
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment