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Study stopped due to lack of accrual
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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arixtra (Fondaparinox) 2.5 mg SC Daily | Active Comparator | Arixtra (Fondaparinox) 2.5 mg SC Daily |
|
| Lovenox 40mg SC Daily | Active Comparator | Lovenox 40mg SC Daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Deep Vein Thrombosis | Confirmed by Lower Extremity Ultra-sonogram | 14 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Kruklitis, MD | Lehigh Valley Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lehigh Valley Hospital Muhlenberg | Bethlehem | Pennsylvania | 18017 | United States |
one patient was a screened failure- after consent found to have an exclusion criteria during screening
Unable to recruit suitable subjects is the reason this study was terminated early
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| ID | Title | Description |
|---|---|---|
| FG000 | Arixtra (Fondaparinox) 2.5 mg Given Subcutaneously (SC) Daily | 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 |
| FG001 | Lovenox 40mg Subcutaneously (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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
see comments under "limitations"- the study apparently enrolled 1 participant and it is not documented which group that patient was assigned to- so we cannot confirm patients in either group- the total enrolled is 1. The study was done so long ago no one from the study team is available and there is no documentation as to which group this 1 patient was randomized to.
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| ID | Title | Description |
|---|---|---|
| BG000 | Arixtra (Fondaparinox) 2.5 mg Given SubCutaneously Daily | 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 |
| BG001 | Lovenox 40mg SubCutaneously Daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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 | Posted | 14 days |
|
14 days
Does not differ
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arixtra (Fondaparinox) 2.5 mg Given SC Daily | Arixtra (Fondaparinox) 2.5 mg given Subcutaneously (SC)once a day Arixtra: Arixtra 2.5mg Sc Daily |
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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
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Leslie Baga, Director of Research | Lehigh Valley Health Network | 610 402 1285 | Leslie.Baga@lvhn.org |
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| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077425 | Fondaparinux |
| D017984 | Enoxaparin |
| ID | Term |
|---|---|
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D006495 | Heparin, Low-Molecular-Weight |
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|
| Lovenox 40mg SC Daily | Drug | Patients will be randomized to receive Lovenox 40mg SC Daily if randomized to this arm |
|
|
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 |
| BG002 | Total | Total of all reporting groups |
|
| Age, Continuous |
| Sex: Female, Male |
|
| Region of Enrollment | participants |
|
Lovenox 40mg Subcutaneously (SC) Daily Lovenox: Lovenox 40mg SC Daily |
|
| Secondary | Deep Vein Thrombosis | Confirmed by Lower Extremity Ultra-sonogram | 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. | Posted | 14 Days |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Lovenox 40mg SC Daily | Lovenox 40mg Subcutaneously (SC) Daily Lovenox: Lovenox 40mg SC Daily | 0 | 0 | 0 | 0 | 0 | 0 |
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| D006493 |
| Heparin |
| D006025 | Glycosaminoglycans |