Thromboprophylaxis in Critically Ill Patients
|ClinicalTrials.gov Identifier: NCT00437697|
Recruitment Status : Terminated
First Posted : February 21, 2007
Last Update Posted : February 21, 2007
Intensive care patients are at high risk to develop deep venous thrombosis and pulmonary embolism. Despite anticoagulation with heparin 7% of ICU patients suffer from this serious complication. Optimal regimens for prevention of VTE have been established in medical patients only and are not known for ICU patients.
It was therefore the aim of this study to compare the bioavailability of a low molecular weight heparin in ICU patients and in medical patients. Furthermore, we looked wether a 50% dose increase resulted in better bioavailability of this drug.
|Condition or disease||Intervention/treatment||Phase|
|Venous Thromboembolism||Drug: dalteparin||Phase 4|
Background: The optimal dose regimen of low molecular weight heparins (LMWH) for thromboprophylaxis in critically ill patients is unknown.
Objectives: We performed a prospective, randomized study to determine anti-Xa activities following subcutaneous administration of 5000 IU or 7500 IU dalteparin for thromboprophylaxis in ICU patients compared with medical patients receiving the standard dose of 5000 IU.
Patients and Methods: Twenty-five ICU patients received 7500 IU (group 1) and 29 ICU patients received 5000 IU dalteparin subcutaneously (group 2) for thromboprophylaxis. Twenty-nine medical patients receiving 5000 IU dalteparin served as control group (group 3).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Thromboprophylaxis in Critically Ill Patients: a Prospective, Randomized Study Comparing Anti-Xa Activities Following Subcutaneous Administration of 5000 IU and 7500 IU Dalteparin|
|Study Start Date :||April 2003|
|Estimated Study Completion Date :||April 2005|
- Area under the curve of measured anti-Xa activities between baseline and 12 hours (AUC-anti-Xa0-12).
- Peak anti-Xa activities at any time (C-max anti-Xa)
- Time of peak anti-Xa-activities (t-max anti-Xa).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00437697
|Medical University of Vienna|
|Vienna, Austria, 1090|
|Principal Investigator:||Ute Priglinger, MD||Medical University of Vienna|