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Argatroban in Critically Ill Patients With Heparin Resistance

Information source: Medical University Innsbruck
ClinicalTrials.gov processed this data on November 27, 2014
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Achievement of a Sufficient Thrombosis Prohpylaxis in Clitically Ill Patients With Heparin Resistance

Intervention: Argatroban (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Medical University Innsbruck

Overall contact:
Mirjam Bachler, MA, Phone: +43512504, Ext: 80451, Email: mirjam.bachler@i-med.ac.at

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 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).

Clinical Details

Official title: A Pilot Trial to Assess the Efficacy of Argatroban (Argatra®) in Critically Ill Patients With Heparin Resistance

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Percentage of patients who achieved the prophylactic aPTT-range within 6 - 8 hours (Visit 3).

Eligibility

Minimum age: 18 Years. Maximum age: 85 Years. Gender(s): Both.

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

Locations and Contacts

Mirjam Bachler, MA, Phone: +43512504, Ext: 80451, Email: mirjam.bachler@i-med.ac.at

Medical University Innsbruck / Department for General and Surgical Intensive Care Medicine, Innsbruck 6020, Austria; Recruiting
Mirjam Bachler, MA, Phone: +43512504, Ext: 80451, Email: mirjam.bachler@i-med.ac.at
Dietmar Fries, MD, Principal Investigator
Additional Information

Starting date: June 2012
Last updated: November 21, 2012

Page last updated: November 27, 2014

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