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

NCT00445328

Last updated date
Study Location
Pfizer Investigational Site
Hyderabad, Andhra Pradesh, 500 068, India
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Venous Thromboembolism
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Dalteparin vs Unfractionated Heparin For The Prevention Of Venous Thromboembolism (VTE) In Hospitalized Acutely Ill Medical Patients
Official Title  ICMJE 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.
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 regarding the study in the decision to terminate the trial.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Venous Thromboembolism
Intervention  ICMJE
  • Drug: Dalteparin (Fragmin)
    Dalteparin 5000 IU once daily subcutaneously for 6-14 days.
  • Drug: Unfractionated heparin
    Unfractionated heparin 5000 IU thrice daily subcutaneously for 6-14 days.
Study Arms  ICMJE
  • Active Comparator: B
    Intervention: Drug: Unfractionated heparin
  • Experimental: A
    Intervention: Drug: Dalteparin (Fragmin)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 16, 2008)
84
Original Enrollment  ICMJE
 (submitted: March 7, 2007)
360
Actual Study Completion Date  ICMJE July 2008
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00445328
Other Study ID Numbers  ICMJE A6301080
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer Inc
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP