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

Pfizer

Status and phase

Terminated

Phase 4

Conditions

Venous Thromboembolism

Treatments

Drug: Unfractionated heparin

Drug: Dalteparin (Fragmin)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00445328

A6301080

Details and patient eligibility

About

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.

Full 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.

Enrollment

84 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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