Thrombelastography Based Dosing of Enoxaparin

NCT00990236 | Completed Results DMC

• 1 other identifier: 001-01
• Study Type: interventional
• Target: 185
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

deep vein thrombosis; superficial venous thrombosis; pulmonary embolus

Outcome Measures

Primary Outcomes (1)

• Development of Deep Vein Thrombosis (DVT)

  An ultrasound duplex will be completed at least one time after randomization to determine if the subject has developed a DVT.

  Through study completion, assessed up to 120 days post randomization

Secondary Outcomes (1)

• Incidence of Bleeding Complications

  Through study completion, assessed up to 120 days post randomization

Study Arms (2)

Enoxaparin 30 mg BID

ACTIVE COMPARATOR

standard dose enoxaparin thromboprophylaxis (30 mg twice daily)

Drug: Enoxaparin 30 mg BID

Enoxaparin dose adjusted based on TEG

EXPERIMENTAL

enoxaparin dose modified based on TEG results

Drug: Enoxaparin dose adjusted Lovenox based on TEG

Interventions

Enoxaparin dose adjusted Lovenox based on TEG DRUG

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.

Also known as: enoxaparin, lovenox

Enoxaparin dose adjusted based on TEG

Enoxaparin 30 mg BID DRUG

Enoxaparin dose of 30 mg twice a day without any adjustments

Also known as: enoxaparin, lovenox

Enoxaparin 30 mg BID

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Inpatient initiated on enoxaparin thromboprophylaxis
• Age greater than 15 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Medical Research Foundation, Oregon: collaborator
• National Trauma Research Institute: collaborator

Study Sites (3)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

University of Texas Health Science Center at Houston

Houston, Texas, United States

Location

University of Washington

Seattle, Washington, United States

Location

Related Publications (1)

• Connelly CR, Van PY, Hart KD, Louis SG, Fair KA, Erickson AS, Rick EA, Simeon EC, Bulger EM, Arbabi S, Holcomb JB, Moore LJ, Schreiber MA. Thrombelastography-Based Dosing of Enoxaparin for Thromboprophylaxis in Trauma and Surgical Patients: A Randomized Clinical Trial. JAMA Surg. 2016 Oct 19;151(10):e162069. doi: 10.1001/jamasurg.2016.2069. Epub 2016 Oct 19.

  PMID: 27487253 DERIVED

MeSH Terms

Conditions

Venous Thrombosis; Pulmonary Embolism

Interventions

Enoxaparin; BID protein, human

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Embolism

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Samantha Underwood, Research Manager
• Organization: Oregon Health & Science University

traumare@ohsu.edu

503-494-8481

Study Officials

• Martin Schreiber, MD FACS

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor & Chief of Trauma

Study Record Dates

• First Submitted: September 29, 2009
• First Posted: October 6, 2009
• Study Start: September 1, 2009
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: April 3, 2020
• Results First Posted: March 16, 2020

Record last verified: 2020-03

Locations

US (3)