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. 2018 Jan 24;2018(1):CD006649. doi: 10.1002/14651858.CD006649.pub7

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.
Outcomes Duration of follow‐up: 3 months.
  • Mortality.

  • Recurrent symptomatic VTE.

  • Major bleeding.

  • Minor bleeding.


Screening and diagnostic testing for DVT: venography.
Screening and diagnostic testing for PE: perfusion lung scan.
Notes
  • Setting: not reported.

  • Funding: not reported.

  • Ethical approval: "The protocol was approved by the ethical committee of Grenoble (France) University."

  • Conflict of interest: not reported.

  • ITT analysis: not reported.

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.