Simonneau 1997 (THESEE).
Methods | Randomized controlled trial. | |
Participants | 60 people with cancer with PE (study subgroup); minimum age 18 years; minimum life expectancy 3 months. | |
Interventions | Intervention: tinzaparin 175 antiXa U/kg SC once daily. Control: UFH IV (target aPTT 2‐3) x 5 days. Oral anticoagulation (target INR 2‐3) started on 1st to 3rd day x at least 3 months. Discontinued treatment: not reported for cancer subgroup. |
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Outcomes | Duration of follow‐up: 90 days.
Screening and diagnostic testing for DVT: ultrasonography or venography. Screening and diagnostic testing for PE: ventilation‐perfusion scanning or angiography. |
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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: "central randomization was performed." |
Allocation concealment (selection bias) | Low risk | Quote: "central randomization was performed with the use of a 24 hour computer service." |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "unblinded trial." 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: "All the scans were reviewed independently and scored accordingly to this method by two readers, each unaware of the patient's treatment assignment." 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. |