Ferrara 2006.
| Methods | Open, randomised, controlled clinical trial | |
| Participants | Number: 192 participants Group 1: 68 participants, involved a single collecting vein. 24 participants had undergone orthopaedic surgery, 22 abdominal surgery and 22 urological surgery. The thrombus was present in a single collecting vein in 48 of these participants and in a single muscular vein in 20. This group was subdivided into 2 subgroups of 34 participants (called 1A and 1B); in the 1A subgroup, the treatment was continued for 12 weeks, and in the 1B subgroup, it was continued for 6 weeks. Group 2: 124 participants involved > 1 collecting vein. 35 participants had undergone orthopaedic surgery, 45 abdominal surgery and 44 urological surgery. 89 of these participants with distal DVT in > 1 vessel presented with thrombotic lesions in 2 vessels and 35 participants had thrombotic lesions in 3 vessels. This group was divided into 2 subgroups of 62 participants (called 2A and 2B); in the 2A subgroup, treatment was continued for 12 weeks, and in the 2B subgroup, it was continued for 6 weeks. Age (range; years): 44–71, group 1; 48–72, group 2 Gender (M/F): 23/45, group 1; 41/83, group 2 |
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| Interventions | VKAs for 12 weeks vs VKAs for 6 weeks. All participants were treated with nadroparin calcium at daily doses of 200 IU anti‐Xa per kg bodyweight, given in 2 doses. Contemporarily, sodium warfarin was administered, and nadroparin was stopped until prothrombin activity had stabilised at about 30–40% with an INR of 2–3. Heparin treatment was stopped in all participants after 5 or 6 days. |
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| Outcomes | Extension of calf DVT to proximal veins, symptomatic PE and major bleeding | |
| Notes | People with cancer, inherited coagulopathies (factor V Leiden, G20120 mutation in prothrombin, hyperhomocystinaemia, dysplasminogenaemia, deficits in vitamin C or protein S, dysfibrinogenaemia), hyperviscosity syndromes or antiphospholipid antibodies, or absolute or relative contraindications for heparin or anticoagulant treatment were excluded. Funding/support: not reported |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Insufficient information about the sequence generation process. |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information about the allocation concealment. |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Open‐label study. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | No blinding of outcome assessment but the review authors judged that the outcome measurement was unlikely to be influenced by lack of blinding. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing data. |
| Selective reporting (reporting bias) | Low risk | The published report included all expected outcomes. |
| Other bias | Low risk | The study appeared free of other sources of bias. |