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Comparison of Arixtra vs. Lovenox to Prevent Blood Clots in Medically Ill Patients (BRiEF)

Primary Purpose

Venous Thrombosis

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Arixtra (Fondaparinox) 2.5 mg SC Daily

Lovenox 40mg SC Daily

About this trial

This is an interventional prevention trial for Venous Thrombosis focused on measuring Bleeding rates, Prophylaxis for deep vein thrombosis

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female > 40 years of age.
Pt with expected stay in hospital 6 days or >, with expectation to be bedridden for > 4 days.
Pts admitted to the MICU, Regional Heart Units of LV-MHC

Exclusion Criteria:

Surgical primary admission diagnosis
Recent surgery within the past 12 weeks
Planned surgery on the current admission
Pregnancy
Vent-dependent respiratory failure requiring intubation for >24 hours.
Known current DVT or PE prior to enrollment in study.
Creatinine clearance < 30 mL/min (calculated by the Cockcroft-Gault method) in a well-hydrated patient.
Hx of prior or current lower upper or lower GI bleed.
Platelet count < 100,000 per cubic millimeter
Current or prior anticoagulation within the prior 48 hours, excluding a single dose &lor 24 hour period of prophylactic agent
Bacterial endocarditis.
Hemophilia
Hypersensitivity to aspirin.
Hypersensitivity to Arixtra or Lovenox
Hx of hemorrhagic or ischemic stroke < 3 months prior to enrolling
Hematocrit < 28%.
SBP >200 mmHg or DBP >120 mmHg
Positive for occult blood in stool.
Admission to hospital for > 48 hours prior to randomization
Documented congenital or acquired bleeding disorder
Indwelling intrathecal or epidural catheter
Life expectancy < 30 days
Inability to have a flu assessment post-discharge from the hospital

Sites / Locations

Lehigh Valley Hospital Muhlenberg

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Arixtra (Fondaparinox) 2.5 mg SC Daily

Lovenox 40mg SC Daily

Arm Description

Arixtra (Fondaparinox) 2.5 mg SC Daily

Lovenox 40mg SC Daily

Outcomes

Primary Outcome Measures

Bleeding Rate Study Day 1-14 (Minor vs Major) With 30 Day f/u

Bleeding Rate- Major bleeding defined as one or a combination of the following: Fatal; Bleeding at critical organ sites (intracranial, retroperitoneal, intraocular, pericardial, spinal or adrenal). Minor Bleeding defined as clinically overt bleeding that is not major bleeding.

Secondary Outcome Measures

Deep Vein Thrombosis

Confirmed by Lower Extremity Ultra-sonogram

Full Information

NCT ID

NCT00521885

First Posted

August 24, 2007

Last Updated

October 14, 2021

Sponsor

Lehigh Valley Hospital

Collaborators

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00521885

Brief Title

Comparison of Arixtra vs. Lovenox to Prevent Blood Clots in Medically Ill Patients

Acronym

BRiEF

Official Title

Arixtra(Fondaparinux) vs. Lovenox (Enoxaparin) in Prevention of DVT in Acute Medically Ill, Non-surgical Patients

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Terminated

Why Stopped

Study stopped due to lack of accrual

Study Start Date

September 2007 (undefined)

Primary Completion Date

September 2009 (Actual)

Study Completion Date

September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Lehigh Valley Hospital

Collaborators

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

A total of 50 patients >40 yrs of age with an expected hospital stay in the Medical Intensive Care or Regional Heart Unit at LVH Muhlenberg of 6 days or longer will be enrolled. The patient and study team will be blinded to which drug they are receiving (either Arixtra or Lovenox). Subjects will be examined for any bleeding complications. Subjects will receive drug for a total of 6-14 days while in the hospital. A follow up phone call will be performed by the study team approximately 30 days after discharge from the hospital.

Detailed Description

A total of 50 patients will be enrolled in this double-blinded, randomized, controlled trial. Inclusion criteria: subjects>40 yrs of age with an expected hospital stay in the Medical Intensive Care or Regional Heart Unit at LVH Muhlenberg of 6 days or longer (4 days bedridden) will be enrolled. Total drug treatment will be 6-14 days while in the hospital. A follow up phone call will be performed by the study team approximately 30 days after hospital discharge. Primary endpoint: bleeding rate (minor vs major) between study days 1-14. Secondary endpoint: DVT study days 1-14 (confirmed with LE duplex ultrasonogram).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Venous Thrombosis

Keywords

Bleeding rates, Prophylaxis for deep vein thrombosis

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arixtra (Fondaparinox) 2.5 mg SC Daily

Arm Type

Active Comparator

Arm Description

Arixtra (Fondaparinox) 2.5 mg SC Daily

Arm Title

Lovenox 40mg SC Daily

Arm Type

Active Comparator

Arm Description

Lovenox 40mg SC Daily

Intervention Type

Drug

Intervention Name(s)

Arixtra (Fondaparinox) 2.5 mg SC Daily

Other Intervention Name(s)

fondaparinux

Intervention Description

Patients will be randomized to receive Arixtra 2.5mg once a day if randomized to this arm

Intervention Type

Drug

Intervention Name(s)

Lovenox 40mg SC Daily

Other Intervention Name(s)

enoxaparin

Intervention Description

Patients will be randomized to receive Lovenox 40mg SC Daily if randomized to this arm

Primary Outcome Measure Information:

Title

Bleeding Rate Study Day 1-14 (Minor vs Major) With 30 Day f/u

Description

Time Frame

14 days

Secondary Outcome Measure Information:

Title

Deep Vein Thrombosis

Description

Confirmed by Lower Extremity Ultra-sonogram

Time Frame

14 Days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female > 40 years of age. Pt with expected stay in hospital 6 days or >, with expectation to be bedridden for > 4 days. Pts admitted to the MICU, Regional Heart Units of LV-MHC Exclusion Criteria: Surgical primary admission diagnosis Recent surgery within the past 12 weeks Planned surgery on the current admission Pregnancy Vent-dependent respiratory failure requiring intubation for >24 hours. Known current DVT or PE prior to enrollment in study. Creatinine clearance < 30 mL/min (calculated by the Cockcroft-Gault method) in a well-hydrated patient. Hx of prior or current lower upper or lower GI bleed. Platelet count < 100,000 per cubic millimeter Current or prior anticoagulation within the prior 48 hours, excluding a single dose &lor 24 hour period of prophylactic agent Bacterial endocarditis. Hemophilia Hypersensitivity to aspirin. Hypersensitivity to Arixtra or Lovenox Hx of hemorrhagic or ischemic stroke < 3 months prior to enrolling Hematocrit < 28%. SBP >200 mmHg or DBP >120 mmHg Positive for occult blood in stool. Admission to hospital for > 48 hours prior to randomization Documented congenital or acquired bleeding disorder Indwelling intrathecal or epidural catheter Life expectancy < 30 days Inability to have a flu assessment post-discharge from the hospital

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert Kruklitis, MD

Organizational Affiliation

Lehigh Valley Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Lehigh Valley Hospital Muhlenberg

City

Bethlehem

State/Province

Pennsylvania

ZIP/Postal Code

18017

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Comparison of Arixtra vs. Lovenox to Prevent Blood Clots in Medically Ill Patients

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