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. 2020 Apr 9;2020(4):CD013422. doi: 10.1002/14651858.CD013422.pub2

Lagerstedt 1985.

Methods Randomised, open label trial
52 randomised, 1 excluded and lost follow‐up
Participants Number: 51 participants
23 received warfarin and 28 control group with no anticoagulation
Age (mean ± SD; years); 65.0 ± 14.4, warfarin group; 60.9 ± 12.4, control group
Gender (M/F): 14/9, warfarin group; 15/13, control group
Interventions UFH/warfarin for 3 months vs no anticoagulation
All participants received a 5‐day course of sodium heparin intravenously, 500–600 IU/kg/day in 6 divided doses.
Intervention: participants receiving oral anticoagulation were started on warfarin as soon as a diagnosis was confirmed by phlebography. The aim was to achieve an INR of 2.5–4.2. Heparin treatment was extended for 1–2 days if the therapeutic level was not reached on the 5th day.
Control: no anticoagulation
All participants were asked to wear graded compression stocking during the study
Outcomes VTE recurrence, clinical or revealed (or both) on imaging
Notes People with previous VTE, PE, thrombi extending into popliteal vein, malignancy were excluded.
Funding/support: quote: "The study was supported in part by grants from the National Organisation against Heart and Lung Diseases."
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Used sealed envelopes.
Allocation concealment (selection bias) Low risk Used sealed envelopes.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Open‐label study.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk No blinding of outcome assessment but the review authors judged that the outcome measurement was unlikely to be influenced by lack of blinding.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No missing data.
Selective reporting (reporting bias) Low risk Published report included all expected outcomes.
Other bias Low risk Study appeared free of other sources of bias.