Comparison of Arixtra vs. Lovenox to Prevent Blood Clots in Medically Ill Patients
| Status: | Terminated |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 40 - Any |
| Updated: | 12/8/2017 |
| Start Date: | September 2007 |
| End Date: | September 2009 |
Arixtra(Fondaparinux) vs. Lovenox (Enoxaparin) in Prevention of DVT in Acute Medically Ill, Non-surgical Patients
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.
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).
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).
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
We found this trial at
1
site
2545 Schoenersville Rd
Bethlehem, Pennsylvania 18017
Bethlehem, Pennsylvania 18017
(484) 884-2200
Lehigh Valley Hospital - Muhlenberg At Lehigh Valley Health Network, we continually go the extra...
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