NCT00521885

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Lehigh Valley Hospital · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Venous Thrombosis

Interventions

Type	Name	Description
DRUG	Arixtra (Fondaparinox) 2.5 mg SC Daily	Patients will be randomized to receive Arixtra 2.5mg once a day if randomized to this arm
DRUG	Lovenox 40mg SC Daily	Patients will be randomized to receive Lovenox 40mg SC Daily if randomized to this arm

Timeline

• Start date: 2007-09-01
• Primary completion: 2009-09-01
• Completion: 2009-09-01
• First posted: 2007-08-28
• Last updated: 2021-10-29
• Results posted: 2017-11-01

Locations

1 site across 1 country: United States