Pilot Study 02 :: ArgHeR

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A pilot trial to assess the efficacy of Argatroban (Argatra®) in critically ill patients with heparin resistance   
Argatroban in Critically Ill Patients with HR
Prospective, monocentric, open-labelled, randomised parallel-grouped Clinical Trial

Primary Objective: The objective is to achieve a prophylactic anticoagulation level within 7(+/-1) hours after Baseline.
Primary Endpoint: Percentage of patients, who achieved the prophylactic aPTT-range within 6 – 8 hours (Visit 3).

Study Start: June 2012
End of study (anticipated): June 2014

Number of Patients: 44 (2x22) patients
Duration of Patient Participation: 30 days Dates of Study

Investigational Medicinal Product
HEPARIN (Heparin-Natrium-25000 ratiopharm®) ARGATROBAN (Argatra®)

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

• 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

This Clinical Trial is planned as a prospective, monocentric, open-labelled, randomised parallel-grouped trial. Patients will be randomized according to a computer-generated randomization list. The recruitment will last until 44 (2x22) patients have been included. All patients have to achieve a prophylactic aPTT-target range of an aPTT-level of 45 – 60 sec (Pathromtin® SL) within 6 - 8 hours. Randomisation Group A: The Heparin administration will be stopped and Argatroban will be given and adjusted until the target aPTT-range is achieved. If the therapy fails the patient has to drop out. Randomisation Group H – Standard therapy: The Heparin administration will be continued and, if necessary increased. Hereby the maximum heparin dose is 1.500 IU per hour. If the therapy fails the patient has to switch to Group A.

Medical University Innsbruck Department of General and Surgical Intensive Care Medicine

A.Univ.-Prof. Dr. Dietmar Fries

Medical University Innsbruck Department of General and Surgical Intensive Care Medicine


DOWNLOAD the excel file below and print it for every patient included. This is a tool to help calculating and maintaining the timepoints of study specific blood withdrawal for study patients.
1.    download the excel file
2.    fill out all fields marked yellow
(Patient Number [after patient randomisation], Patient Name, Inclusion Time and Date)
3.    study specific timepoints of taking blood samples will be calculated automatically (blue fields)
4.    print the excel file
5.    put on adhesive patient label
(if possible)
6.    leave the printout with the patient (e.g. inside the patient file)
7.    when taking study specific blood samples fill out the respective white field (realized at…)