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

Phase 4

Terminated

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
B	Unfractionated heparin	-
A	Dalteparin (Fragmin)	-

Primary Outcome Measures

Name	Time	Method
Confirmed Thromboembolic Events	Day 21	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.
Composite of Objectively Verified Thromboembolic Events	Day 21	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'.

Secondary Outcome Measures

Name	Time	Method
All Cause Mortality	Day 14, Day 21 (End of Study)	Subjects with death from any cause: end of study.
Stroke - Ischemic or Hemorrhagic	Day 21	Subjects with stroke (either ischemic or hemorrhagic) based on results of CT (computed tomographic) pulmonary angiography
Bleeding - Major or Minor	Day 21	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.
Allergic Reactions (Drug-related)	Day 21	Subjects with drug-related allergic reactions
Thrombocytopenia	Day 21	Subjects with thrombocytopenia (low platelets).