Marchiori 2002.
Methods | Single‐centre RCT. | |
Participants | 60 consecutive participants with ST of great saphenous vein confirmed by ultrasonography; 26 males, 34 females; mean age 62 years. Not reported if participants were hospitalised or non‐hospitalised. | |
Interventions | UFH (12,500 IU sc for 1 week then 10,000 IU). UFH (5000 IU). Study treatment given for 4 weeks. |
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Outcomes | Asymptomatic and symptomatic recurrence or extension of ST and VTE (or both recurrence and extension) after treatment and at 3 and 6 months. Safety outcomes: major bleeding, HIT, overall mortality. |
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Notes | Systemic or local anti‐inflammatory drugs (or both) allowed. Funding: not reported. Disclosure of potential COI: the authors report no COI. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐based: "List generated by a computer." |
Allocation concealment (selection bias) | Unclear risk | Method of allocation concealment not reported. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Ultrasound assessment performed by blinded investigators. However, not reported if participants and investigators evaluating all other events were blind to study treatment. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing outcome data. |
Selective reporting (reporting bias) | Low risk | All prespecified outcomes reported. |