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Dalteparin vs Unfractionated Heparin For The Prevention Of Venous Thromboembolism (VTE) In Hospitalized Acutely Ill Medical Patients

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ClinicalTrials.gov Identifier: NCT00445328
Recruitment Status : Terminated (See Detailed Description)
First Posted : March 8, 2007
Results First Posted : October 2, 2009
Last Update Posted : October 15, 2009
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Venous Thromboembolism Drug: Dalteparin (Fragmin) Drug: Unfractionated heparin Phase 4

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Start Date : June 2007
Primary Completion Date : July 2008
Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: B Drug: Unfractionated heparin
Unfractionated heparin 5000 IU thrice daily subcutaneously for 6-14 days.
Experimental: A Drug: Dalteparin (Fragmin)
Dalteparin 5000 IU once daily subcutaneously for 6-14 days.

Outcome Measures

Primary Outcome Measures :
  1. Confirmed Thromboembolic Events [ Time Frame: Day 21 ]
  2. Composite of Objectively Verified Thromboembolic Events [ Time Frame: Day 21 ]

Secondary Outcome Measures :
  1. All Cause Mortality [ Time Frame: Day 14, Day 21 (End of Study) ]
  2. Stroke - Ischemic or Hemorrhagic [ Time Frame: Day 21 ]
  3. Bleeding - Major or Minor [ Time Frame: Day 21 ]
  4. Allergic Reactions (Drug-related) [ Time Frame: Day 21 ]
  5. Thrombocytopenia [ Time Frame: Day 21 ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00445328

Pfizer Investigational Site
Hyderabad, Andhra Pradesh, India, 500 068
Pfizer Investigational Site
Ahmedabad, Gujarat, India, 380 054
Pfizer Investigational Site
Trichur, Kerala, India, 680 005
Pfizer Investigational Site
Indore, Madhya Pradesh, India, 452001
Pfizer Investigational Site
Chennai, Tamil Nadu, India, 600 006
Pfizer Investigational Site
Kolkata, West Bengal, India, 700 029
Pfizer Investigational Site
Kolkata, West Bengal, India, 700 054
Sponsors and Collaborators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00445328     History of Changes
Other Study ID Numbers: A6301080
First Posted: March 8, 2007    Key Record Dates
Results First Posted: October 2, 2009
Last Update Posted: October 15, 2009
Last Verified: October 2009

Keywords provided by Pfizer:
hospitalised acutely medically ill patients; Venous Thromboembolism, Infection, Inflammatory Bowel Diseases, Heart Failure, Congestive, Sciatica

Additional relevant MeSH terms:
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Calcium heparin
Heparin, Low-Molecular-Weight
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action