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| Study Type: | Interventional |
|---|---|
| Study Design: | Randomized, Open Label, Parallel Assignment |
| Condition: |
Venous Thromboembolism |
| Interventions: |
Drug: Dalteparin (Fragmin) Drug: Unfractionated heparin |
Participant Flow
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
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| No text entered. |
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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| No text entered. |
| Description | |
|---|---|
| Dalteparin | 5000 IU (International Units) dalteparin in 0.2 mL (milliliters) subcutaneously once a day (Arm A) |
| Unfractionated Heparin | 5000 IU unfractionated Heparin (UFH) in 5 mL subcutaneously 3 times a day (Arm B) for 6 to 14 days. |
| Dalteparin | Unfractionated Heparin | |
|---|---|---|
| STARTED | 42 | 42 |
| Received Treatment | 41[1] | 42 |
| COMPLETED | 39 | 36 |
| NOT COMPLETED | 3 | 6 |
| Death | 0 | 1 |
| Adverse Event | 0 | 3 |
| unknown | 0 | 2 |
| Withdrawal by Subject | 2 | 0 |
| Protocol Violation | 1 | 0 |
| [1] | 1 subject discontinued after enrollment but prior to study treatment. |
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Baseline Characteristics
| Description | |
|---|---|
| Dalteparin | 5000 IU dalteparin in 0.2 mL subcutaneously once a day (Arm A) |
| Unfractionated Heparin | 5000 IU unfractionated Heparin (UFH) in 5 mL subcutaneously 3 times a day (Arm B) for 6 to 14 days. |
| Dalteparin | Unfractionated Heparin | Total | |
|---|---|---|---|
|
Number of Participants [units: participants] |
41 | 42 | 83 |
|
Age [units: years] Mean ± Standard Deviation |
61.7 ± 10.6 | 60.8 ± 10.9 | 61.3 ± 10.7 |
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Gender [units: participants] |
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| Female | 18 | 21 | 39 |
| Male | 23 | 21 | 44 |
Outcome Measures
| 1. Primary: | Confirmed Thromboembolic Events [ Day 21 ] |
| 2. Primary: | Composite of Objectively Verified Thromboembolic Events [ Day 21 ] |
| 3. Secondary: | All Cause Mortality [ Day 14, Day 21 (End of Study) ] |
| 4. Secondary: | Stroke - Ischemic or Hemorrhagic [ Day 21 ] |
| 5. Secondary: | Bleeding - Major or Minor [ Day 21 ] |
| 6. Secondary: | Allergic Reactions (Drug-related) [ Day 21 ] |
| 7. Secondary: | Thrombocytopenia [ Day 21 ] |