NCT00437697

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2003

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

February 20, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 21, 2007

Completed
Last Updated

February 21, 2007

Status Verified

February 1, 2007

First QC Date

February 20, 2007

Last Update Submit

February 20, 2007

Conditions

Venous Thromboembolism

Keywords

dalteparin, critically ill, thromboprophylaxis

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

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

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

Interventions

dalteparinDRUG

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Requirement for prophylactic anticoagulation, patient age ³19 years, creatinine clearance within normal range, prothrombin time \>30% and thrombocyte counts \>100 G/l.

You may not qualify if:

  • Estimated time of admission less than 24 hours, full anticoagulation, renal failure, history of heparin-induced thrombocytopenia, hereditary or acquired coagulation disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Venous ThromboembolismCritical Illness

Interventions

Dalteparin

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-WeightHeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Ute Priglinger, MD

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 20, 2007

First Posted

February 21, 2007

Study Start

April 1, 2003

Study Completion

April 1, 2005

Last Updated

February 21, 2007

Record last verified: 2007-02

Locations

AU(1)