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

Venous Thrombosis Clinical Trial

— BRiEF  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00521885
• Other study ID #: LVH IRB# 2-20070508
• Status: Terminated
• Phase: N/A
• Start date: September 2007
• Est. completion date: September 2009

Study information

• Verified date: November 2017
• Source: Lehigh Valley Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Thrombosis
• Venous Thrombosis

Intervention

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

Locations

Country	Name	City	State
United States	Lehigh Valley Hospital Muhlenberg	Bethlehem	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Lehigh Valley Hospital	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Deep Vein Thrombosis	Confirmed by Lower Extremity Ultra-sonogram	14 Days