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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Venous Thromboembolism

Intervention / Treatment
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* Drug: Dalteparin (Fragmin)
* Drug: Unfractionated heparin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: B<br> | Drug: Unfractionated heparin<br>* Unfractionated heparin 5000 IU thrice daily subcutaneously for 6-14 days.<br>|
| Experimental: A<br> | Drug: Dalteparin (Fragmin)<br>* Dalteparin 5000 IU once daily subcutaneously for 6-14 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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'. | Day 21 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All Cause Mortality | Subjects with death from any cause: end of study. | 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 | 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. | Day 21 | 
| Allergic Reactions (Drug-related) | Subjects with drug-related allergic reactions | Day 21 | 
| Thrombocytopenia | Subjects with thrombocytopenia (low platelets). | Day 21 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hospitalised acutely medically ill patients; Venous Thromboembolism, Infection, Inflammatory Bowel Diseases, Heart Failure, Congestive, Sciatica