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

This study has been completed.

Study NCT00585182 Information provided by University of Utah

First Received on December 21, 2007. Last Updated on August 2, 2011 History of Changes

Results First Received: August 2, 2011

Study Type:	Interventional
Study Design:	Endpoint Classification: Pharmacokinetics Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Prevention
Conditions:	Obesity Venous Thrombosis Anticoagulants
Intervention:	Drug: Enoxaparin 0.5 mg/kg once daily

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
28 patients met eligibility criteria and completed the protocol enrolled from the University of Utah Hospital Inpatient Medical Service

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
NA

Reporting Groups

	Description
Enoxaparin 0.5mg/kg Once Daily	No text entered.

Participant Flow: Overall Study

	Enoxaparin 0.5mg/kg Once Daily
STARTED	28
COMPLETED	28
NOT COMPLETED	0

Baseline Characteristics

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Reporting Groups

	Description
Enoxaparin 0.5mg/kg Once Daily	No text entered.

Baseline Measures

	Enoxaparin 0.5mg/kg Once Daily
Number of Participants [units: participants]	28
Age [units: participants]
<=18 years	0
Between 18 and 65 years	23
>=65 years	5
Age [units: years] Mean ± Standard Deviation	54 ± 11
Gender [units: participants]
Female	13
Male	15
Region of Enrollment [units: participants]
United States	28

Outcome Measures

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1. Primary:

Peak Low Molecular Weight Heparin Anti-Xa Activity Level. [ Time Frame: Day 2 ]

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2. Secondary:

Clinically Relevant Bleeding [ Time Frame: Through hospitalization ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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:

Name/Title: Dr Robert Pendleton
Organization: University of Utah
phone: 801 581 7818
e-mail: robert.pendleton@hsc.utah.edu

No publications provided

Responsible Party:	Robert C Pendleton, University of Utah
ClinicalTrials.gov Identifier:	NCT00585182 History of Changes
Other Study ID Numbers:	20115, Utah IRB 20115
Study First Received:	December 21, 2007
Results First Received:	August 2, 2011
Last Updated:	August 2, 2011
Health Authority:	United States: Institutional Review Board