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Thrombelastography Based Dosing of Enoxaparin

NCT00990236 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 185

Last updated 2020-04-03

Study results available
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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.

Conditions

  • Thromboembolic Complications

Interventions

DRUG

Enoxaparin dose adjusted Lovenox based on TEG

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.

DRUG

Enoxaparin 30 mg BID

Enoxaparin dose of 30 mg twice a day without any adjustments

Sponsors & Collaborators

  • Medical Research Foundation, Oregon

    collaborator OTHER

  • National Trauma Research Institute

    collaborator OTHER

  • Oregon Health and Science University

    lead OTHER

Principal Investigators

  • Martin Schreiber, MD FACS · Oregon Health and Science University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2015-03-31
Completion
2015-03-31

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 NCT00990236 on ClinicalTrials.gov