Study to Evaluate Weight-based Enoxaparin Dosing in Obese Medical Patients at Risk for DVT

NCT00585182 | Completed Phase 4 Results DMC

• 2 other identifiers: 20115Utah IRB 20115
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Deep vein thrombosis(DVT) is a common complication in hospitalized medical patients. Consensus guidelines recommend using medications such as heparin or low-molecular-weight heparins (LMWH) to prevent DVT in these patients. Generally, these medications are given in a fixed dose that is the same for everyone. The appropriate dose of medication in patients with severe obesity is uncertain. There is some evidence that the use of standard fixed-doses in severely obese patients may not provide adequate protection against DVT. The purpose of this study is to evaluate a weight-based dose(0.5 milligrams per kilogram of body weight) of the commonly prescribed LMWH, enoxaparin in severely obese patients to determine if predictable levels of blood thinning can be achieved. We hypothesize that dosing enoxaparin 0.5mg/kg once daily in severely obese patients will lead to predictable blood levels.

Conditions

Obesity; Venous Thrombosis; Anticoagulants

Keywords

Obesity; venous thrombosis; Anticoagulants

Outcome Measures

Primary Outcomes (1)

• Peak Low Molecular Weight Heparin Anti-Xa Activity Level.

  The Rotachrom® assay using the STA-Compact instrument (Diagnostica Stago, Parsippany, NJ) was used to quantitate anti- Xa (LMWH) activity for enoxaparin. The sensitivity of this assay is 0.2 U/mL and within run imprecision is 5.5 (% CV) at 1 U/mL. The assay is linear between 0.2-2.0 U/mL

  4 - 6 hours after enoxaparin dosing on Day 1 and Day 2

Secondary Outcomes (1)

• Clinically Relevant Bleeding Events

  Participants were followed for the duration of hospital stay, an average of 5 days

Study Arms (1)

1

EXPERIMENTAL

Drug: Enoxaparin 0.5 mg/kg once daily

Interventions

Enoxaparin 0.5 mg/kg once daily DRUG

Enoxaparin 0.5 mg/kg (kg= actual body weight) subcutaneous once daily for 2 doses.

Also known as: Lovenox

1

Eligibility Criteria

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

You may qualify if:

• Obese patients (BMI\>35kg/m2)\>18 years of age admitted to medical service and considered at increased risk for DVT and whom pharmacological prophylaxis is being considered by treating physician.

You may not qualify if:

• Pregnancy
• Currently on alternate therapeutic anticoagulant (warfarin, heparin, LMWH)
• Platelet count \<100,000, CrCl \<30ml/min, or coagulopathy
• recent (within 14 d) stroke, trauma, or major surgical procedure
• Active bleeding or deemed at increased bleeding risk by the investigator.

Sponsors & Collaborators

• University of Utah: lead
• Sanofi: collaborator

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Obesity; Venous Thrombosis

Interventions

Enoxaparin

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

This study was limited by a relatively small sample size, lack of long-term clinical outcome data, and the use of only a single anti-Xa level, rather than repeat measures.

Results Point of Contact

• Title: Dr Robert Pendleton
• Organization: University of Utah

robert.pendleton@hsc.utah.edu

801 581 7818

Study Officials

• Robert C Pendleton, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 3, 2008
• Study Start: January 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: April 5, 2018
• Results First Posted: September 5, 2011

Record last verified: 2018-03

Locations

US (1)