Thromboprophylaxis in Critically Ill Patients

Venous Thromboembolism Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00437697
• Other study ID #: 008/2003
• Status: Terminated
• Phase: Phase 4
• First received: February 20, 2007
• Last updated: February 20, 2007
• Start date: April 2003
• Est. completion date: April 2005

Study information

• Verified date: February 2007
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 90
• Est. completion date: April 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Critical Illness
• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• dalteparin

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve of measured anti-Xa activities between baseline and 12 hours (AUC-anti-Xa0-12).
Secondary	Peak anti-Xa activities at any time (C-max anti-Xa)
Secondary	Time of peak anti-Xa-activities (t-max anti-Xa).