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Thromboprophylaxis in Critically Ill Patients

Primary Purpose

Venous Thromboembolism

Status
Terminated
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
dalteparin
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Venous Thromboembolism focused on measuring dalteparin, critically ill, thromboprophylaxis

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Medical University of Vienna

Outcomes

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).

Full Information

First Posted
February 20, 2007
Last Updated
February 20, 2007
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT00437697
Brief Title
Thromboprophylaxis in Critically Ill Patients
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 Type
Interventional

2. Study Status

Record Verification Date
February 2007
Overall Recruitment Status
Terminated
Study Start Date
April 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Medical University of Vienna

4. Oversight

5. Study Description

Brief 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboembolism
Keywords
dalteparin, critically ill, thromboprophylaxis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
dalteparin
Primary Outcome Measure Information:
Title
Area under the curve of measured anti-Xa activities between baseline and 12 hours (AUC-anti-Xa0-12).
Secondary Outcome Measure Information:
Title
Peak anti-Xa activities at any time (C-max anti-Xa)
Title
Time of peak anti-Xa-activities (t-max anti-Xa).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ute Priglinger, MD
Organizational Affiliation
Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

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Thromboprophylaxis in Critically Ill Patients

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