Clinical trial NCT00445328: Dalteparin vs Unfractionated Heparin For The Prevention Of Venous Thromboembolism (VTE) In Hospitalized Acutely Ill Medical Patients
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Venous Thromboembolism
Keywords: hospitalised acutely medically ill patients; Venous Thromboembolism, Infection, Inflammatory Bowel Diseases, Heart Failure, Congestive, Sciatica
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-03-08
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Confirmed Thromboembolic Events
timeFrame: Day 21
measure: Composite of Objectively Verified Thromboembolic Events
timeFrame: Day 21
Secondary outcomes:
measure: All Cause Mortality
timeFrame: Day 14, Day 21 (End of Study)
measure: Stroke - Ischemic or Hemorrhagic
timeFrame: Day 21
measure: Bleeding - Major or Minor
timeFrame: Day 21
measure: Allergic Reactions (Drug-related)
timeFrame: Day 21
measure: Thrombocytopenia
timeFrame: Day 21
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Pfizer Investigational Site
state: Andhra Pradesh
city: Ahmedabad
country: India
facility: Pfizer Investigational Site
state: Gujarat
city: Trichur
country: India
facility: Pfizer Investigational Site
state: Kerala
city: Indore
country: India
facility: Pfizer Investigational Site
state: Madhya Pradesh
city: Chennai
country: India
facility: Pfizer Investigational Site
state: Tamil Nadu
city: Kolkata
country: India
facility: Pfizer Investigational Site
state: West Bengal
city: Kolkata
country: India
facility: Pfizer Investigational Site
state: West Bengal
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: