N/A N=185 Randomized Double-blind Prevention

Thrombelastography Based Dosing of Enoxaparin

Thromboembolic Complications

Bottom Line

View on ClinicalTrials.gov: NCT00990236 ↗

Enrolled (actual)

185

Serious AEs

0.5%

Results posted

Mar 2020

Primary outcome: Primary: Development of Deep Vein Thrombosis (DVT) — 6; 5 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Enoxaparin dose adjusted Lovenox based on TEG (Drug); Enoxaparin 30 mg BID (Drug)
Age: Pediatric, Adult, Older Adult · 15+ yrs
Sex: All
Sponsor: Oregon Health and Science University
Primary completion: Mar 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Development of Deep Vein Thrombosis (DVT)	6; 5	—
SECONDARY Incidence of Bleeding Complications	5; 13	—

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.

Eligibility Criteria

Inclusion Criteria

Inpatient initiated on enoxaparin thromboprophylaxis
Age greater than 15 years

Exclusion Criteria

Unable to obtain consent from patient or ARR
Presence of: intracranial hemorrhage, brain injury
Receiving therapeutic dose enoxaparin
Receiving other forms of anticoagulation
Receiving non-standard dosing regimen of enoxaparin

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00990236). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.