Simonneau 1993.
Methods | Randomized controlled trial. | |
Participants | 9 people with cancer with proximal DVT (study subgroup); minimum age 18 years. | |
Interventions | Intervention: enoxaparin 1 mg/kg SC twice daily. Control: UFH IV (target aPTT 1.5‐2.5) x 10 days. Oral anticoagulation (target INR 2‐3) started on day 10 for at least 3 months. Discontinued treatment: not reported for cancer subgroup. |
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Outcomes | Duration of follow‐up: 3 months.
Screening and diagnostic testing for DVT: venography. Screening and diagnostic testing for PE: perfusion lung scan. |
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Notes |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "The randomization code was drafted by means of a standard random number table randomizing in blocks of four." |
Allocation concealment (selection bias) | Low risk | Quote: "The patients' treatment assignments were taken from sealed envelopes." |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No placebo given. Comment: definitely not blinded; knowledge of the assigned intervention may have led to differential behaviors across intervention groups (e.g. differential dropout, differential cross‐over to an alternative intervention, or differential administration of cointerventions). |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Venograms, perfusion lung scans, and pulmonary angiograms were subsequently reviewed by a central independent panel of two consultant specialists unaware of the treatment allocation." Comment: definitely blinded. |
Incomplete outcome data addressed? | Low risk | Complete follow‐up. |
Free of selective reporting? | Low risk | Study not registered and no published protocol identified. All relevant outcomes listed in the methods section were reported on in the results section. |
Free of other bias? | Low risk | Study not reported as stopped early for benefit. No other bias suspected. |