Thromboprophylaxis in Critically Ill Patients
Primary Purpose
Venous Thromboembolism
Status
Terminated
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
dalteparin
Sponsored by
About this trial
This is an interventional prevention trial for Venous Thromboembolism focused on measuring dalteparin, critically ill, thromboprophylaxis
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.
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
NCT ID
NCT00437697
First Posted
February 20, 2007
Last Updated
February 20, 2007
Sponsor
Medical University of Vienna
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
Learn more about this trial
Thromboprophylaxis in Critically Ill Patients
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