Thromboprophylaxis in Critically Ill Patients

Condition(s) targeted: Venous Thromboembolism

Intervention: dalteparin (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Medical University of Vienna

Official(s) and/or principal investigator(s):
Ute Priglinger, MD, Principal Investigator, Affiliation: Medical University of Vienna

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.

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 design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Area under the curve of measured anti-Xa activities between baseline and 12 hours (AUC-anti-Xa0-12).

Secondary outcome:

Peak anti-Xa activities at any time (C-max anti-Xa)

Time of peak anti-Xa-activities (t-max anti-Xa).

Detailed description: 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).

Minimum age: 19 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Requirement for prophylactic anticoagulation, patient age ³19 years, creatinine

clearance within normal range, prothrombin time >30% and thrombocyte counts >100 G/l. Exclusion Criteria:

- Estimated time of admission less than 24 hours, full anticoagulation, renal failure,

history of heparin-induced thrombocytopenia, hereditary or acquired coagulation disorders.

Medical University of Vienna, Vienna 1090, Austria

Starting date: April 2003
Last updated: February 20, 2007