Dalteparin vs Unfractionated Heparin For The Prevention Of Venous Thromboembolism (VTE) In Hospitalized Acutely Ill Medical Patients
Information source: Pfizer
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Venous Thromboembolism
Intervention: Dalteparin (Fragmin) (Drug); Unfractionated heparin (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: Pfizer Official(s) and/or principal investigator(s): Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
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.
Clinical Details
Official title: Prospective Randomized Phase IV Open Label Comparative Study Of Dalteparin vs Unfractionated Heparin For The Prevention Of Venous Thromboembolism (VTE) In Hospitalized Acutely Ill Medical Patients.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Confirmed Thromboembolic EventsComposite of Objectively Verified Thromboembolic Events
Secondary outcome: All Cause MortalityStroke - Ischemic or Hemorrhagic Bleeding - Major or Minor Allergic Reactions (Drug-related) Thrombocytopenia
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 regarding the study in the decision to terminate the trial.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Locations and Contacts
Pfizer Investigational Site, Hyderabad, Andhra Pradesh 500 068, India
Pfizer Investigational Site, Ahmedabad, Gujarat 380 054, India
Pfizer Investigational Site, Trichur, Kerala 680 005, India
Pfizer Investigational Site, Indore, Madhya Pradesh 452001, India
Pfizer Investigational Site, Chennai, Tamil Nadu 600 006, India
Pfizer Investigational Site, Kolkata, West Bengal 700 029, India
Pfizer Investigational Site, Kolkata, West Bengal 700 054, India
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: June 2007
Last updated: October 5, 2009
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