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. 2021 Jan 19;2021(1):CD002783. doi: 10.1002/14651858.CD002783.pub5

Turpie 1990.

Study characteristics
Methods Allocation: random
Double blind
Exclusions after randomisation: nil
Losses to follow‐up: 37
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
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
Outcomes 24 ‐ 48 hours: clot lysis; bleeding
3 years: post‐thrombotic syndrome
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