Schulman 1986.
| Methods | Allocation: random Single blind Exclusions after randomisation: 2 Losses to follow‐up: nil |
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| Participants | Country: Sweden Participants: 38 Age: 26 to 74 years Sex: Male and female Inclusion criteria: venographically confirmed calf vein thrombosis duration < 7 days Exclusion criteria: previous thrombosis same leg; contraindication to thrombolysis |
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| Interventions | Treatment: streptokinase 50,000 IU IV over 15 minutes then 100,000 IU over 12 hours for up to 7 days, titrated. Given with 5000 IU heparin IV over 12 hours. Warfarin begun after streptokinase ended Control: heparin 5000 IU IV bolus then 30,000 IU per day, titrated for 7 days. Warfarin begun simultaneously Co‐treatment: paracetamol, hydrocortisone or moduretic if necessary. 24 hours bed rest. Warfarin given for 5 to 6 months. Leg elevation. Elastic bandages. Elastic stockings where swelling or venous insufficiency detected at discharge or follow‐up |
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| Outcomes | 1 week: bleeding; clot lysis (venographic score); mortality; stroke; PE 1 month: clot lysis 1 year: clot lysis Up to 5 years: post‐thrombotic syndrome; foot volumetry |
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| Notes | Low dose streptokinase. 2 patients excluded after randomisation, as they had previous thromboses | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "randomised, prospective study" but no further details given |
| Allocation concealment (selection bias) | Low risk | "allocated using sealed envelopes" |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | not possible due to the nature of the interventions but judged low risk as outcome assessment well described |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | "..venograms were evaluated blindly in retrospect by one and the same radiologist" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | no missing data |
| Selective reporting (reporting bias) | Low risk | all outcomes reported |
| Other bias | Low risk | none |