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Trial record 7 of 95 for:    Open Studies | "Heparin"

Argatroban in Critically Ill Patients With Heparin Resistance

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2012 by Medical University Innsbruck.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Dietmar Fries, M.D., Medical University Innsbruck
ClinicalTrials.gov Identifier:
NCT01734252
First received: November 21, 2012
Last updated: NA
Last verified: November 2012
History: No changes posted
  Purpose

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 12 (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 12 (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 3 more adjustements 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 hours (T3), 24 hours (T4), 48 hours (T5), 3 days (T6), 4 days (T7), 5 days (T8), 6 days (T9) and 7 days (T10) after Baseline and 6 h after study medication stop (T11). 30 days after inclusion in the study, a final investigation is planned (T12).


Condition Intervention Phase
Achievement of a Sufficient Thrombosis Prohpylaxis in Clitically Ill Patients With Heparin Resistance
Drug: Argatroban
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Trial to Assess the Efficacy of Argatroban (Argatra®) in Critically Ill Patients With Heparin Resistance

Resource links provided by NLM:


Further study details as provided by Medical University Innsbruck:

Primary Outcome Measures:
  • Percentage of patients who achieved the prophylactic aPTT-range within 6 - 8 hours (Visit 3). [ Time Frame: The average period for the measurement (aPTT) of the primary outcome is 7 hours. Timepoints of measurements are at Baseline (hour 0) and after 6-8 hours. ] [ Designated as safety issue: No ]
    The primary measure is to achieve a prophylactic anticoagulation level within 7(+/-1) hours after Baseline. The parameter to define the anticoagulation level is aPTT and will be measured at 7(+/-1) hours.


Estimated Enrollment: 44
Study Start Date: June 2012
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard Treatment
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.
Experimental: Treatment with Argatroban
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.
Drug: Argatroban
Start: Argatroban dose [µg/kg x min] = 2.06 - 0.03 x SAPS II until maximum: 10 µg/kg/min

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

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
  • Surgical procedure with the need for interruption of antithrombotic therapy within the next 24 hours
  • FXII-deficiency
  • Lupus anticoagulant
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01734252

Contacts
Contact: Mirjam Bachler, MA +43512504 ext 80451 mirjam.bachler@i-med.ac.at
Contact: Dietmar Fries, MD +43512504 ext 80455 dietmar.fries@uki.at

Locations
Austria
Medical University Innsbruck / Department for General and Surgical Intensive Care Medicine Recruiting
Innsbruck, Austria, 6020
Contact: Mirjam Bachler, MA    +43512504 ext 80451    mirjam.bachler@i-med.ac.at   
Principal Investigator: Dietmar Fries, MD         
Sponsors and Collaborators
Medical University Innsbruck
  More Information

No publications provided

Responsible Party: Dietmar Fries, M.D., Coordinating and Principal Investigator, Medical University Innsbruck
ClinicalTrials.gov Identifier: NCT01734252     History of Changes
Other Study ID Numbers: ArgHeR
Study First Received: November 21, 2012
Last Updated: November 21, 2012
Health Authority: Austria: Federal Office for Safety in Health Care

Additional relevant MeSH terms:
Critical Illness
Thrombosis
Cardiovascular Diseases
Disease Attributes
Embolism and Thrombosis
Pathologic Processes
Vascular Diseases
Argatroban
Heparin
Anticoagulants
Antithrombins
Cardiovascular Agents
Enzyme Inhibitors
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Platelet Aggregation Inhibitors
Protease Inhibitors
Serine Proteinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014