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Evaluation Of Enoxaparin Pharmacokinetic For Thromboprophylaxis In Burn Care Patients

NCT01421537 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 180

Last updated 2020-08-03

No results posted yet for this study

Summary

OVERVIEW:

* Thromboembolisms represent a serious and feared complication in hospitalized patients.
* Several factors make the ICU patient population at increased risk of venous thromboembolism.
* A high incidence of thromboembolic events is starting to emerge from recent medical literature in the burn patient.
* Actual guidelines for thromboprophylaxis in burn care patients are based on multiple non-burn patient trials.
* Burn patient physiology is radically different than that of general ward hospitalized patients
* Since the actual chemical thromboprophylaxis have not been evaluated in the burn patient, it is of interest to assess their efficacy in patients with severe burns.
* Hence, the pharmacokinetic characterization of heparins (a well accepted mode of thromboprophylaxis) in burn patients could guide future quality of care for this subclass of patients.

Our proposal is based on the conviction that anti-Xa activity of low-molecular-weight heparins in the burn patients do not correlate with levels described to prevent thromboembolic events in the general hospitalized population.

The investigators aim to:

1. To evaluate pharmacokinetics and pharmacodynamics of low-molecular-weight heparins (enoxaparin), with anti-Xa levels in severely burned patients receiving thromboprophylaxis.
2. To determine the correlation between antithrombotic activity of heparins and the different metabolic phases of the thermally injured patient.

Conditions

  • Skin Burn Extensive

Sponsors & Collaborators

  • Centre hospitalier de l'Université de Montréal (CHUM)

    lead OTHER

Principal Investigators

  • Dominique Lafrance, MD · Centre hospitalier de l'Université de Montréal (CHUM)

  • Anita Ang, M. Sc · Centre hospitalier de l'Université de Montréal (CHUM)

  • Nicholas Robillard, MD · Centre hospitalier de l'Université de Montréal (CHUM)

  • Mikhael Laskine, MD · CHUM

  • Normand Blais, MD · CHUM

  • Sylvain Belisle, MD · CHUM

  • Marc-Jacques Dubois, MD · CHUM

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2013-01-31
Completion
2013-01-31

Countries

  • Canada

Study Locations

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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 NCT01421537 on ClinicalTrials.gov