Turpie 1990.
Study characteristics | ||
Methods | Allocation: random Double blind Exclusions after randomisation: nil Losses to follow‐up: 37 |
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Participants | Country: Canada Participants: 83 Age: < 75 years Sex: not described Inclusion criteria: venographically confirmed proximal DVT of lower limb duration < 7 days Exclusion criteria: bleeding dysfunction; active bleeding; peptic ulcer; stroke or intracranial process < 2 months; surgery, trauma, childbirth, biopsy, vessel puncture < 7 days |
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Interventions | Treatment: IV heparin 5000 U bolus then 30,000 U/24 hours, adjusted for 7 ‐ 10 days
Phase 1: two chain tPA 0.5 mg/kg IV over 4 hours
Phase 2: one chain tPA 0.5 mg/kg IV over 8 hours and repeated in 24 hours Control: identical placebo to tPA depending on phase, plus heparin as above Co‐treatment: warfarin commenced for 3 months |
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Outcomes | 24 ‐ 48 hours: clot lysis; bleeding 3 years: post‐thrombotic syndrome |
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Funding | This study was supported by a grant (MA 9872) from the Medical Research Council of Canada | |
Declaration of interests | Not reported | |
Notes | 22 died, 15 "not available" for intermediate to late follow‐up | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Randomly allocated" no further details |
Allocation concealment (selection bias) | Unclear risk | Not described clearly |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | "Identical appearing placebo" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "Venograms interpreted by an independent panel without knowledge of the clinical findings or the treatment group" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All reported |
Selective reporting (reporting bias) | Low risk | All reported |
Other bias | Low risk | None |