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The Clinical Utility of Thrombelastography in Guiding Prophylaxis of Venous Thromboembolism Following Trauma

NCT01050153 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2019-01-08

Study results available
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Summary

This study plans to learn more about how to prevent blood clots in the veins of your extremities. You are at risk of forming these clots after a major injury and when you have had surgery and are hospitalized on bed rest.

Usually, patients in the SICU at Denver Health who are at risk for blood clots receive preventative treatment with a FDA-approved medicine called Fragmin. Fragmin is intended to prevent blood clots from forming but, with the way it is generally used, some patients may still develop blood clots. All patients treated with Fragmin to prevent blood clots at Denver Health, currently receive the same Fragmin dose. This treatment is called the "standard of care".

So far, in the US, there has not been a commonly available test that can tell us:

* if the standard dose of Fragmin is enough to prevent blood clots for everyone, or
* if different patients need different doses, or
* if other blood clot preventing medicines, that work in a different way, should be used in addition to Fragmin.

The ability of your blood to clot and the strength of the clot formed can be described by a FDA-approved blood test called thrombelastography, referred to as TEG. TEG may provide us with answers to each of the questions above. Our preliminary data indicate that it is helpful in assessing both clotting and bleeding tendencies and may prove useful in guiding treatment for the prevention of blood clots.

The aim of this study is to determine if a treatment plan using Fragmin, and, if indicated, one or two additional FDA-approved medicines called anti-platelet drugs, guided by the results of TEG testing, may be better at preventing blood clots than our current standard of care.

Conditions

  • Venous Thromboembolism

Interventions

DRUG

Dalteparin sodium

Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory

DRUG

Dalteparin sodium/aspirin

Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily) po.

Sponsors & Collaborators

  • Eisai Inc.

    collaborator INDUSTRY

  • Denver Health and Hospital Authority

    lead OTHER

Principal Investigators

  • Ernest E. Moore Jr, M.D. · Chief, Department of Surgery and Trauma Services , Denver Health Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • United States

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 NCT01050153 on ClinicalTrials.gov