Venous Thrombosis
Conditions
Keywords
Bleeding rates, Prophylaxis for deep vein thrombosis
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.
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).
Interventions
DRUGArixtra (Fondaparinox) 2.5 mg SC Daily
Patients will be randomized to receive Arixtra 2.5mg once a day if randomized to this arm
DRUGLovenox 40mg SC Daily
Patients will be randomized to receive Lovenox 40mg SC Daily if randomized to this arm
Sponsors
GlaxoSmithKline
Lehigh Valley Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Deep Vein Thrombosis | 14 Days | Confirmed by Lower Extremity Ultra-sonogram |
Countries
United States
Participant flow
Recruitment details
Unable to recruit suitable subjects is the reason this study was terminated early
Pre-assignment details
one patient was a screened failure- after consent found to have an exclusion criteria during screening
Participants by arm
| Arm | Count |
|---|---|
| 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 | 0 |
| Lovenox 40mg SubCutaneously 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 | 0 |
| Total | 0 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Region of Enrollment United States | — participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: 14 days
Population: 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
Secondary
Deep Vein Thrombosis
Confirmed by Lower Extremity Ultra-sonogram
Time frame: 14 Days
Population: 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.