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

NCT00521885 | Terminated Results DMC

• 1 other identifier: LVH IRB# 2-20070508
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Venous Thrombosis

Keywords

Bleeding rates; Prophylaxis for deep vein thrombosis

Outcome Measures

Primary Outcomes (1)

• 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.

  14 days

Secondary Outcomes (1)

• Deep Vein Thrombosis

  14 Days

Study Arms (2)

Arixtra (Fondaparinox) 2.5 mg SC Daily

ACTIVE COMPARATOR

Arixtra (Fondaparinox) 2.5 mg SC Daily

Drug: Arixtra (Fondaparinox) 2.5 mg SC Daily

Lovenox 40mg SC Daily

ACTIVE COMPARATOR

Lovenox 40mg SC Daily

Drug: Lovenox 40mg SC Daily

Interventions

Arixtra (Fondaparinox) 2.5 mg SC Daily DRUG

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

Also known as: fondaparinux

Arixtra (Fondaparinox) 2.5 mg SC Daily

Lovenox 40mg SC Daily DRUG

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

Also known as: enoxaparin

Lovenox 40mg SC Daily

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lehigh Valley Hospital: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Lehigh Valley Hospital Muhlenberg

Bethlehem, Pennsylvania, 18017, United States

Location

MeSH Terms

Conditions

Venous Thrombosis

Interventions

Fondaparinux; Enoxaparin

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

Began 2007 and ended 2009-1 subject enrolled-no SAE noted. No records which arm enrolled subject was assigned, so cannot accurately fill the patient flow section as "1" to match enroll number. Unknown what arm subject in. Only blinded pharm.was aware

Results Point of Contact

• Title: Leslie Baga, Director of Research
• Organization: Lehigh Valley Health Network

Leslie.Baga@lvhn.org

610 402 1285

Study Officials

• Robert Kruklitis, MD

  Lehigh Valley Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2007
• First Posted: August 28, 2007
• Study Start: September 1, 2007
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: October 29, 2021
• Results First Posted: November 1, 2017

Record last verified: 2017-11

Locations

US (1)