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

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Hyderabad, Andhra Pradesh, 500 068 India
Contact
1-800-718-1021
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

NCT00445328
Pfizer
Terminated
Dalteparin vs Unfractionated Heparin For The Prevention Of Venous Thromboembolism (VTE) In Hospitalized Acutely Ill Medical Patients

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Dalteparin vs Unfractionated Heparin For The Prevention Of Venous Thromboembolism (VTE) In Hospitalized Acutely Ill Medical Patients
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.
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.
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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Venous Thromboembolism
  • 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.
  • Active Comparator: B
    Intervention: Drug: Unfractionated heparin
  • Experimental: A
    Intervention: Drug: Dalteparin (Fragmin)
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
84
July 2008
July 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
India
 
 
NCT00445328
A6301080
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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