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

NCT ID: NCT00521885

Last Updated: 2021-10-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2009-09-30

Brief Summary

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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

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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).

Conditions

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Venous Thrombosis

Keywords

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Bleeding rates Prophylaxis for deep vein thrombosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Arixtra (Fondaparinox) 2.5 mg SC Daily

Arixtra (Fondaparinox) 2.5 mg SC Daily

Group Type ACTIVE_COMPARATOR

Arixtra (Fondaparinox) 2.5 mg SC Daily

Intervention Type DRUG

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

Lovenox 40mg SC Daily

Lovenox 40mg SC Daily

Group Type ACTIVE_COMPARATOR

Lovenox 40mg SC Daily

Intervention Type DRUG

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

Interventions

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Arixtra (Fondaparinox) 2.5 mg SC Daily

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

Intervention Type DRUG

Lovenox 40mg SC Daily

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

Intervention Type DRUG

Other Intervention Names

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fondaparinux enoxaparin

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

Lehigh Valley Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert Kruklitis, MD

Role: PRINCIPAL_INVESTIGATOR

Lehigh Valley Hospital

Locations

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Lehigh Valley Hospital Muhlenberg

Bethlehem, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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LVH IRB# 2-20070508

Identifier Type: -

Identifier Source: org_study_id