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NCT00445328 Clinical Trial

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

Venous Thromboembolism Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00445328
Other study ID # A6301080
Secondary ID
Status Terminated
Phase Phase 4
First received March 7, 2007
Last updated October 5, 2009
Start date June 2007
Est. completion date July 2008

Study information
Verified date October 2009
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority India: Institutional Review Board
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 84
Est. completion date July 2008
Est. primary completion date July 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Dalteparin (Fragmin)
Dalteparin 5000 IU once daily subcutaneously for 6-14 days.
• Unfractionated heparin
Unfractionated heparin 5000 IU thrice daily subcutaneously for 6-14 days.

Locations
Country Name City State
India Pfizer Investigational Site Ahmedabad Gujarat
India Pfizer Investigational Site Chennai Tamil Nadu
India Pfizer Investigational Site Hyderabad Andhra Pradesh
India Pfizer Investigational Site Indore Madhya Pradesh
India Pfizer Investigational Site Kolkata West Bengal
India Pfizer Investigational Site Kolkata West Bengal
India Pfizer Investigational Site Trichur Kerala

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

India, 

Outcome
Type Measure Description Time frame Safety issue
Primary Confirmed Thromboembolic Events Day 21 Yes
Primary Composite of Objectively Verified Thromboembolic Events Day 21 Yes
Secondary All Cause Mortality Day 14, Day 21 (End of Study) Yes
Secondary Stroke - Ischemic or Hemorrhagic Day 21 Yes
Secondary Bleeding - Major or Minor Day 21 Yes
Secondary Allergic Reactions (Drug-related) Day 21 Yes
Secondary Thrombocytopenia Day 21 Yes
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