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Argatroban in Critically Ill Patients With Heparin Resistance

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01734252
First Posted: November 27, 2012
Last Update Posted: November 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dietmar Fries, M.D., Medical University Innsbruck
  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 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).


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
Intervention Model: Parallel Assignment
Masking: None (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 Dietmar Fries, M.D., 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. ]
    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.


Enrollment: 44
Actual Study Start Date: July 29, 2012
Study Completion Date: April 1, 2016
Primary Completion Date: April 1, 2016 (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 is 0.05 µg/kg/min (patients with hepatic impairment, after cardiac surgery) until maximum: 10 µg/kg/min

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
  • 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01734252


Locations
Austria
Medical University Innsbruck / Department for General and Surgical Intensive Care Medicine
Innsbruck, Austria, 6020
Sponsors and Collaborators
Medical University Innsbruck
  More Information

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
First Submitted: November 21, 2012
First Posted: November 27, 2012
Last Update Posted: November 16, 2017
Last Verified: November 2017

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