UPETSG 1970.
Study characteristics | ||
Methods |
Study design: multicentre, randomised controlled trial Method of randomisation: telephone to Drug Assignment Center Blinding: double‐blind Duration: October 1968 to August 1970 Exclusions post‐randomisation: 1 Losses to follow‐up: 1 |
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Participants |
Country: USA Setting: 14 centres No. of participants: 160: 82 in urokinase group, 78 in heparin group Age (years): not clearly stated Sex: 47 men, 35 women in urokinase group; 45 men, 33 women in heparin group Inclusion criteria: well‐documented clinical episode suggesting PE had occurred within 5 days of start of therapy Exclusion criteria: recent operation, contraindication to use of anticoagulant or thrombolytic therapy |
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Interventions |
Treatment group: 2 brands of urokinase ‐ Urokinase (Abbott) and Winkinase (Sterling‐Winthrop) ‐ were given randomly by 12‐hour infusion. Loading dose of 2000 CTA IU/lb in 10 minutes, then 2000 CTA IU/lb for 12 hours via infusion pump Control group: heparin; loading dose of 75 IU/lb, then 10 IU/lb/h for 12‐hour infusion Both groups then received heparin for a minimum of 5 days, followed by heparin or warfarin therapy for a total of 14 days. Dosage not clear Follow‐up: 6 to 18 hours after completion of test drug infusion, then at 2 weeks and 3, 6, and 12 months |
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Outcomes |
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Funding | No details were provided | |
Declaration of interests | No details were provided | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Drug Assignment Center |
Allocation concealment (selection bias) | Low risk | Telephone to Drug Assignment Center |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Double‐blind |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing data |
Selective reporting (reporting bias) | Unclear risk | No information provided |
Other bias | Unclear risk | Small sample size may be a source of other bias |