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

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.
Outcomes Duration of follow‐up: 90 days.
  • Mortality.

  • Symptomatic recurrent VTE.

  • Major bleeding.


Screening and diagnostic testing for DVT: ultrasonography or venography.
Screening and diagnostic testing for PE: ventilation‐perfusion scanning or angiography.
Notes
  • Setting: not reported.

  • Funding: Leo Pharmaceuticals.

  • Ethical approval: "The study protocol was approved by the institutional review boards of all the participating centers."

  • Conflict of interest: not reported.

  • ITT analysis: "The primary analysis was performed on an intention to treat basis."

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.