CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 185 enrolled
Drug / intervention
Enoxaparin dose adjusted Lovenox based on TEG +1 moredrug
Likely dose
Enoxaparin 30 mg BIDfrom 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/NCT00990236
NCT00990236N/ACompleted

Thrombelastography Based Dosing of Enoxaparin for Thromboprophylaxis: a Prospective Randomized Trial

Oregon Health and Science University·interventional·Posted Oct 6, 2009·Updated Apr 3, 2020

In Brief

A clinical study evaluating Enoxaparin dose adjusted Lovenox based on TEG and Enoxaparin 30 mg BID for Thromboembolic Complications. Completed, enrolled 185 participants across 3 sites.

Detailed Summary

The risk of developing a blood clot occurs in up to 60% of all critical care patients. Many times enoxaparin (or Lovenox®) is given to patients who are at a higher risk of developing clots in their legs or lungs. Recent data suggest that a standard dose of Lovenox may not fully prevent the development of these clots especially in critically ill or obese patients. Routine enoxaparin dosing can also result in bleeding complications. Thrombelastography (TEG®) can be used to measure how blood clots. The purposes of this study are: * to learn if the TEG® can better guide physicians in prescribing an effective dose of Lovenox compared to standard doses recommended by the drug company in preventing blood clots from developing in the legs and lungs, and * to compare the development of blood clots in patients receiving the standard dose of enoxaparin compared to patients receiving a TEG® guided dose of enoxaparin. * to determine if TEG guided dosing results in decreased bleeding complications compared to standard dosing.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 6, 2009
Enrollment StartSep 1, 2009
Primary CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 16.7 years ago

Interventions

Enoxaparin dose adjusted Lovenox based on TEGdrug

Enoxaparin doses will be adjusted (10 mg BID) based on delta-R results from TEG. Delta-R \< 1.0 min - increase dose by 10 mg BID; delta-R \>/= 1.0 min and \</= 2.0 min - no change; delta-R \> 2.0 min - decrease dose by 10 mg BID.

Enoxaparin 30 mg BIDdrug

Enoxaparin dose of 30 mg twice a day without any adjustments