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NCT01050153 · ClinicalTrials.gov registry record · NA
The Clinical Utility of Thrombelastography in Guiding Prophylaxis of Venous Thromboembolism Following Trauma
A NA study of Venous Thromboembolism, sponsored by Denver Health and Hospital Authority.
- Completed
- Registry status
- NA
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT01050153: Completed NA study of Venous Thromboembolism, sponsored by Denver Health and Hospital Authority.
NCT01050153 is a NA study of Venous Thromboembolism that has completed, run by Denver Health and Hospital Authority. The registered enrollment target is 50 participants, below the 6,295-participant average among 47 other Venous Thromboembolism trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01050153, a NA study of Venous Thromboembolism, has completed, sponsored by Denver Health and Hospital Authority.
- COMPLETED
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
To determine the incidence of, and to characterize, hypercoagulability in a sample of trauma patients admitted to the SICU at DHMC using TEG and conventional clinical coagulation testing (APTT, INR), antithrombin III levels and protein C activity. Hypercoagulability is defined as TEG parameter G (clot strength) \>10.9.
Conditions Studied
Interventions
- DRUG Dalteparin sodium
- DRUG Dalteparin sodium/aspirin
Study Locations (1)
Colorado
- Denver Health Medical Center - Denver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2010-03 |
| Est. Completion | 2011-12 |
| Phase | NA |
What the finished NCT01050153 record still lists
NCT01050153 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 6,295-participant average among 47 other Venous Thromboembolism trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Venous Thromboembolism appearing as the primary indexed condition, and to 2 interventions - of which Dalteparin sodium is the first listed.
NCT01050153 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT01050153 about?
NCT01050153 is a clinical study titled "The Clinical Utility of Thrombelastography in Guiding Prophylaxis of Venous Thromboembolism Following Trauma". 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 clot...
What is the current status of trial NCT01050153?
This trial is currently completed. It is a NA study. The enrollment target is 50 participants. The study started on 2010-03. Estimated completion is 2011-12.
What conditions does trial NCT01050153 study?
This clinical trial studies the following conditions: Venous Thromboembolism.
What interventions are being tested in trial NCT01050153?
The interventions under investigation include: Dalteparin sodium (DRUG), Dalteparin sodium/aspirin (DRUG).
Who is sponsoring clinical trial NCT01050153?
This trial is sponsored by Denver Health and Hospital Authority, which has 73 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01050153 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01050153's enrollment target sits among peer trials
50 42nd of 47 higher than 6 of 47 other Venous Thromboembolism trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Venous Thromboembolism trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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