Status:
TERMINATED
Dalteparin vs Unfractionated Heparin For The Prevention Of Venous Thromboembolism (VTE) In Hospitalized Acutely Ill Medical Patients
Lead Sponsor:
Pfizer
Conditions:
Venous Thromboembolism
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to compare the efficacy and safety of dalteparin vs unfractionated heparin for the prevention of VTE (Venous Thromboembolism) in hospitalized acutely ill medical patients.
Detailed Description
The study was prematurely discontinued due to delay in overall study start-up and inability to meet pre-defined protocol recruitment milestones on June 30th, 2008. There were no safety concerns regard...
Eligibility Criteria
Inclusion
- Aged greater than or equal to 18 years
- Acute medical condition with a projected hospitalization of greater than or equal to 4 days and had less than or equal to 3 days of prior immobilization for more than two thirds of the day
- Acute congestive heart failure Class III-IV per NHYA/ Acute respiratory failure not requiring mechanical ventilation or Both
- Acute infection without septic shock/ Acute episode of inflammatory bowel disease/ Acute rheumatologic disorders/ Acute lumbar pain or sciatica or vertebral compression with at least one risk factor for VTE
Exclusion
- Contraindications to use of anticoagulants
- Active bleeding or abnormal coagulation tests
- Recent (less than 1 month) head injury, hemorrhagic stroke, cerebral tumor or intracranial aneurysm or ischemic stroke within the last month.
- Major surgical or invasive procedure within the last month resulting in ongoing convalescence
- Lumbar or spinal puncture within last 48 hours
- S creatinine levels more than 2
- On inotropic agents
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT00445328
Start Date
June 1 2007
End Date
July 1 2008
Last Update
October 15 2009
Active Locations (7)
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1
Pfizer Investigational Site
Hyderabad, Andhra Pradesh, India, 500 068
2
Pfizer Investigational Site
Ahmedabad, Gujarat, India, 380 054
3
Pfizer Investigational Site
Thrissur, Kerala, India, 680 005
4
Pfizer Investigational Site
Indore, Madhya Pradesh, India, 452001