MedTrace Logo

Dalteparin's Influence on Renally Compromised: Anti-Ten-A Study (DIRECT)

NCT00138099 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 140

Last updated 2007-06-01

No results posted yet for this study

Summary

The investigators' primary research objective is:

* To determine the safety of dalteparin prophylaxis, 5,000 IU once-daily, in Intensive Care Unit (ICU) patients based on:

* the proportion of patients with trough anti-Xa \> 0.40 IU/mL during dalteparin prophylaxis after 3 + 1 days, 10 + 1 days, and 17 + 1 days of dalteparin prophylaxis;
* the risk of major bleeding during the treatment period.

The investigators' secondary research objectives are:

* To determine the pharmacokinetic properties of dalteparin prophylaxis in ICU patients with severe renal insufficiency;
* To identify clinical and laboratory factors that predict an excessive anticoagulant effect (anti-Xa \> 0.10 IU/mL);
* To estimate the relationship between trough anti-Xa levels and bleeding.

The DIRECT Pilot Study:

Before embarking on a large trial of low molecular weight heparin (LMWH) versus standard unfractionated heparin (UFH), the DIRECT Study is needed to observe whether bioaccumulation of LMWH occurs in ICU patients with moderate to severe renal insufficiency, and to address potential problems with protocol implementation.

Conditions

  • Renal Insufficiency

Interventions

DRUG

Fragmin (dalteparin sodium)

Sponsors & Collaborators

  • Canadian Critical Care Trials Group

    collaborator OTHER

  • Pfizer

    collaborator INDUSTRY

  • Hamilton Health Sciences Corporation

    lead OTHER

Principal Investigators

  • James Douketis, MD · McMaster University

  • Deborah J Cook, MD · McMaster University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-07-31
Completion
2006-06-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00138099 on ClinicalTrials.gov