PREPIC.
| Methods | Study design: Multicentre study; randomised control open trial using a 2x2 factorial design. Country: France. Intention‐to‐treat analysis. |
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| Participants | Number: 400 participants. Age: 73 +/‐ 11. Sex: 64% were male. Inclusion criteria: Age >18 with documented proximal DVT or PE, and considered high risk for pulmonary embolism. Exclusion criteria:
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| Interventions | (Permanent) caval filter vs no filter LMWH vs unfractionated heparin | |
| Outcomes | Primary outcomes.
Secondary outcomes.
Outcomes assessed at 12 days, two years, eight years. |
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| Notes | Study had low power. Jadad score 3/5 |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Adequate sequence generation? | Low risk | Randomisation was based on a centralised computer system. |
| Allocation concealment? | Unclear risk | Not described. |
| Blinding? Mortality | High risk | Open study design. |
| Blinding? Pulmonary embolism | High risk | Open study design. |
| Incomplete outcome data addressed? Mortality | Low risk | Negligible losses to follow up (only 4 of 400 participants). No missing outcome data. Causes of death reported. Mortality reported at 12 days, two years and eight years. |
| Incomplete outcome data addressed? Pulmonary embolism | Low risk | No missing outcome data. Pulmonary embolism reported at12 days, two years and eight years. |
| Free of selective reporting? | Low risk | Primary and secondary outcomes were reported. |
DVT: deep vein thrombosis LMWH: low molecular weight heparin PE: pulmonary embolism