Heparin resistance in critically ill patients with the need of prophylactic anticoagulation MedDRA version: 18.1 Level: HLT Classification code 10036896 Term: Prophylactic procedures NEC System Organ Class: 100000004865 MedDRA version: 18.1 Level: LLT Classification code 10036893 Term: Prophylactic System Organ Class: 100000004865
Conditions
Interventions
Trade Name: Argatra®
Product Name: Argatra
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: ARGATROBAN
CAS Number: 74863-84-6
Concentration unit: mg/ml milligram(s)/mill
Sponsors
Medizinische Universität Innsbruck / Univ.-Klinik für Allgemeine und Chirurgische Intensivmedizin
Eligibility
Sex/Gender
All
Inclusion 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 9 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 35
Exclusion criteria
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 - Planned 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective 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 for the Primary Objective.;Secondary Objective: - Assessment of thromboembolism after 7 days - Assessment of bleeding complications within 3 - 7 days - Assessment of biological and clinical parameters - Maintenance of the target aPTT within 7 days - Need for readjustment in case of non maintenance of the target aPTT within 7 days - Assessment of transfusion of any blood products - Parameters predictive for an effective Argatroban dose ;Primary end point(s): Percentage of patients who achieved the prophylactic aPTT-range within 6 – 8 hours (Visit 3);Timepoint(s) of evaluation of this end point: At Visit 3 (after 6-8 hours after Baseline) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - number of thromboses at 7 days assessed by duplex ultrasound and/or CT-scan - number of bleeding events assessed by a CT-Scan within 3 – 7 days - other ROTEM® and biological parameters - achievement of the target aPTT within 7 days - amount and type of blood products - correlation between parameters and Argatroban dose ;Timepoint(s) of evaluation of this end point: At Visit 8 (7 days after Baseline) | — |
Countries
Austria
Contacts
Public ContactProjektmanagement
Medizinische Universität Innsbruck / Univ.-Klinik für Allgemeine und Chirurgische Intensivmedizin
Outcome results
None listed