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Thromboprophylaxis in Critically Ill Patients

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00437697
First Posted: February 21, 2007
Last Update Posted: February 21, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Medical University of Vienna
  Purpose

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 Intervention Phase
Venous Thromboembolism Drug: dalteparin Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Further study details as provided by Medical University of Vienna:

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

Secondary Outcome Measures:
  • Peak anti-Xa activities at any time (C-max anti-Xa)
  • Time of peak anti-Xa-activities (t-max anti-Xa).

Estimated Enrollment: 90
Study Start Date: April 2003
Estimated Study Completion Date: April 2005
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).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00437697


Locations
Austria
Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Ute Priglinger, MD Medical University of Vienna
  More Information

ClinicalTrials.gov Identifier: NCT00437697     History of Changes
Other Study ID Numbers: 008/2003
First Submitted: February 20, 2007
First Posted: February 21, 2007
Last Update Posted: February 21, 2007
Last Verified: February 2007

Keywords provided by Medical University of Vienna:
dalteparin, critically ill, thromboprophylaxis

Additional relevant MeSH terms:
Critical Illness
Thromboembolism
Venous Thromboembolism
Disease Attributes
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Dalteparin
Heparin, Low-Molecular-Weight
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action