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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00445328
• Date of registration: 07/03/2007
• Primary sponsor: Pfizer
• Public title: Dalteparin vs Unfractionated Heparin For The Prevention Of Venous Thromboembolism (VTE) In Hospitalized Acutely Ill Medical Patients
• Scientific 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.
• Date of first enrolment: June 2007
• Target sample size: 84
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00445328
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Countries of recruitment

India

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Venous Thromboembolism

Intervention(s)

Drug: Dalteparin (Fragmin)

Drug: Unfractionated heparin

Primary Outcome(s)

Composite of Objectively Verified Thromboembolic Events [Time Frame: Day 21]

Confirmed Thromboembolic Events [Time Frame: Day 21]

Secondary Outcome(s)

All Cause Mortality [Time Frame: Day 14, Day 21 (End of Study)]

Allergic Reactions (Drug-related) [Time Frame: Day 21]

Bleeding - Major or Minor [Time Frame: Day 21]

Stroke - Ischemic or Hemorrhagic [Time Frame: Day 21]

Thrombocytopenia [Time Frame: Day 21]

Secondary ID(s)

A6301080

Source(s) of Monetary Support

Please refer to primary and secondary sponsors