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. 2021 Apr 15;2021(4):CD004437. doi: 10.1002/14651858.CD004437.pub6

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
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
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
Outcomes
  • Morbidity during 2‐week study period

  • Complications

  • Pulmonary angiography (24 hours)

  • Lung scanning

  • Haemodynamic measurements

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