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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
84
Dalteparin 5000 IU once daily subcutaneously for 6-14 days.
Unfractionated heparin 5000 IU thrice daily subcutaneously for 6-14 days.
Pfizer Investigational Site
Hyderabad, Andhra Pradesh, India
Pfizer Investigational Site
Ahmedabad, Gujarat, India
Pfizer Investigational Site
Thrissur, Kerala, India
Pfizer Investigational Site
Indore, Madhya Pradesh, India
Confirmed Thromboembolic Events
Confirmed thromboembolic events = 'present' if any following events are present/abnormal, otherwise = 'absent': Deep vein thrombosis measured by Color Doppler ultrasonography lower limbs; pulmonary embolism by chest xray, ventilation-perfusion scan, computed tomography pulmonary angiography; Sudden Death within 24 hours of venous thromboembolism symptoms.
Time frame: Day 21
Composite of Objectively Verified Thromboembolic Events
Subjects with objectively verified thromboembolic events: symptomatic proximal and distal deep vein thrombosis \[DVT\], asymptomatic proximal DVT, fatal or symptomatic non-fatal pulmonary embolism \[PE\] or sudden death within 24 hours of onset of venous thromboembolism (VTE) symptoms. Occurrence of any ='Present', otherwise = 'Absent'.
Time frame: Day 21
All Cause Mortality
Subjects with death from any cause: end of study.
Time frame: Day 14, Day 21 (End of Study)
Stroke - Ischemic or Hemorrhagic
Subjects with stroke (either ischemic or hemorrhagic) based on results of CT (computed tomographic) pulmonary angiography
Time frame: Day 21
Bleeding - Major or Minor
Subjects with bleeding. Bleeding classified as major if it is: intraocular, spinal/epidural, intracranial or retroperitoneal; or if hemoglobin decreased by ≥ 2 g/dl(grams/deciliter); or if transfusion of ≥ 2 Units of blood or if significant medical or surgical intervention was required; or if it results in death. All other bleeding is classified as minor.
Time frame: Day 21
Allergic Reactions (Drug-related)
Subjects with drug-related allergic reactions
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Pfizer Investigational Site
Chennai, Tamil Nadu, India
Pfizer Investigational Site
Kolkata, West Bengal, India
Pfizer Investigational Site
Kolkata, West Bengal, India
Time frame: Day 21
Thrombocytopenia
Subjects with thrombocytopenia (low platelets).
Time frame: Day 21