CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
Dalteparin sodium +1 moredrug
Likely dose
Dalteparin sodium 5000IUfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01050153
NCT01050153N/ACompleted

An Evaluation of the Clinical Utility of Thrombelastography (TEG) in Guiding Low Molecular Weight Heparin (LMWH) and Antiplatelet Prophylaxis of Venous Thromboembolism (VTE) Following Trauma

Denver Health and Hospital Authority·interventional·Posted Jan 15, 2010·Updated Jan 8, 2019

In Brief

A clinical study evaluating Dalteparin sodium and Dalteparin sodium/aspirin for Venous Thromboembolism. Completed, enrolled 50 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsEisai Inc.

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 15, 2010
Enrollment StartMar 1, 2010
Primary CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 16.5 years ago

Interventions

Dalteparin sodiumdrug

Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory

Dalteparin sodium/aspirindrug

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