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

• Sponsor: Lehigh Valley Hospital (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00521885
• Collaborator: GlaxoSmithKline (Industry)
• Enrollment: 1
• Location: 1
• Arms: 2
• Duration (Months): 24
• Patients Per Site Per Month: 0

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Venous Thrombosis	Drug: Arixtra (Fondaparinox) 2.5 mg SC Daily; Drug: Lovenox 40mg SC Daily	N/A

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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 1 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Arixtra(Fondaparinux) vs. Lovenox (Enoxaparin) in Prevention of DVT in Acute Medically Ill, Non-surgical Patients
• Study Start Date: Sep 1, 2007
• Actual Primary Completion Date: Sep 1, 2009
• Actual Study Completion Date: Sep 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Arixtra (Fondaparinox) 2.5 mg SC Daily Arixtra (Fondaparinox) 2.5 mg SC Daily	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; Other Names: fondaparinux
Active Comparator: Lovenox 40mg SC Daily Lovenox 40mg SC Daily	Drug: Lovenox 40mg SC Daily; Patients will be randomized to receive Lovenox 40mg SC Daily if randomized to this arm; Other Names: enoxaparin

Outcome Measures

Primary Outcome Measures

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

   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

1. Deep Vein Thrombosis [14 Days]

   Confirmed by Lower Extremity Ultra-sonogram

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lehigh Valley Hospital Muhlenberg	Bethlehem	Pennsylvania	United States	18017

Sponsors and Collaborators

• Lehigh Valley Hospital
• GlaxoSmithKline

Investigators

• Principal Investigator: Robert Kruklitis, MD, Lehigh Valley Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lehigh Valley Hospital
• ClinicalTrials.gov Identifier: NCT00521885
• Other Study ID Numbers: LVH IRB# 2-20070508
• First Posted: Aug 28, 2007
• Last Update Posted: Oct 29, 2021
• Last Verified: Nov 1, 2017

• Keywords provided by Lehigh Valley Hospital: Bleeding rates; Prophylaxis for deep vein thrombosis
• Additional relevant MeSH terms: Thrombosis; Venous Thrombosis; Enoxaparin; Fondaparinux

Study Results

Participant Flow

Recruitment Details	Unable to recruit suitable subjects is the reason this study was terminated early
Pre-assignment Detail	one patient was a screened failure- after consent found to have an exclusion criteria during screening

Arm/Group Title	Arixtra (Fondaparinox) 2.5 mg Given Subcutaneously (SC) Daily	Lovenox 40mg Subcutaneously (SC) Daily
Arm/Group Description	In this arm subjects will be randomized to Arixtra (Fondaparinox) 2.5 mg given Subcutaneously (SC) once a day starting on day 1 and continuing through day 14 or day of discharge, whichever comes first. Arixtra: Arixtra 2.5mg Sc Daily	Subjects will be randomized using a random generated listing of numbers with arm assignments associated with each assigned number. Only the study pharmacist will have access to this randomization code. All other study team members will remain blinded to the treatment arm. In this arm subjects will be randomized to Lovenox 40mg Subcutaneously (SC) Daily starting on day 1 and continuing through day 14 or day of discharge, whichever comes first. Lovenox: Lovenox 40mg SC Daily
Period Title: Overall Study
STARTED	0	0
COMPLETED	0	0
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Arixtra (Fondaparinox) 2.5 mg Given SubCutaneously Daily	Lovenox 40mg SubCutaneously Daily	Total
Arm/Group Description	Subjects may be randomized to Arixtra (Fondaparinox) 2.5 mg given SubCutaneously Daily starting on day 1 and continuing through day 14 or day of discharge, whichever comes first Arixtra: Arixtra 2.5mg Sc Daily	Subjects may be randomized to Lovenox 40mg SubCutaneously Daily starting on day 1 and continuing through day 14 or day of discharge, whichever comes first Lovenox: Lovenox 40mg SC Daily	Total of all reporting groups
Overall Participants	0	0	0
Age () []
<=18 years
Between 18 and 65 years
>=65 years
Age () []
Sex: Female, Male () []
Female
Male
Region of Enrollment (participants) []

Outcome Measures

1. Primary Outcome

Title	Bleeding Rate Study Day 1-14 (Minor vs Major) With 30 Day f/u
Description	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.
Time Frame	14 days

Outcome Measure Data

Analysis Population Description

There was only 1 patient enrolled and it is not documented anywhere which group they were assigned to- the study is so old and no one is here who would know; therefore I cannot verify any patients in either group

Arm/Group Title	Arixtra (Fondaparinox) 2.5 mg Given Subcutaneously (SC)Once a	Lovenox 40mg Subcutaneously (SC) Daily
Arm/Group Description	Arixtra (Fondaparinox) 2.5 mg given Subcutaneously (SC)once a day Arixtra: Arixtra 2.5mg Sc Daily	Lovenox 40mg Subcutaneously (SC) Daily Lovenox: Lovenox 40mg SC Daily
Measure Participants	0	0

2. Secondary Outcome

Title	Deep Vein Thrombosis
Description	Confirmed by Lower Extremity Ultra-sonogram
Time Frame	14 Days

Outcome Measure Data

Analysis Population Description

There was 1 patient enrolled and it is not documented which group the patient was assigned therefore I cannot verify which group the patient should be included.

Arm/Group Title	Arixtra (Fondaparinox) 2.5 mg Given Subcutaneously (SC)Once a	Lovenox 40mg Subcutaneously (SC) Daily
Arm/Group Description	Arixtra (Fondaparinox) 2.5 mg given Subcutaneously (SC)once a day Arixtra: Arixtra 2.5mg Sc Daily	Lovenox 40mg Subcutaneously (SC) Daily Lovenox: Lovenox 40mg SC Daily
Measure Participants	0	0

Adverse Events

Time Frame	14 days
Adverse Event Reporting Description	Does not differ
Arm/Group Title	Arixtra (Fondaparinox) 2.5 mg Given SC Daily		Lovenox 40mg SC Daily
Arm/Group Description	Arixtra (Fondaparinox) 2.5 mg given Subcutaneously (SC)once a day Arixtra: Arixtra 2.5mg Sc Daily		Lovenox 40mg Subcutaneously (SC) Daily Lovenox: Lovenox 40mg SC Daily
All Cause Mortality
	Arixtra (Fondaparinox) 2.5 mg Given SC Daily		Lovenox 40mg SC Daily
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	Arixtra (Fondaparinox) 2.5 mg Given SC Daily		Lovenox 40mg SC Daily
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Arixtra (Fondaparinox) 2.5 mg Given SC Daily		Lovenox 40mg SC Daily
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/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

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.