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. 2018 Dec 18;2018(12):CD004437. doi: 10.1002/14651858.CD004437.pub5

Jerjes‐Sánchez 1995.

Methods Study design: single‐centre, prospective, randomised controlled trial
Method of randomisation: "withdrawal of a sealed envelope from a closed box that initially contained 40 envelopes numbered consecutively from 1 to 40; even numbers were assigned to SK + heparin and odd numbers to heparin"; no information provided for concealment of the sequence
Blinding: not described
 Duration: not described
Exclusions post randomisation: none
Losses to follow‐up: none
Participants Country: not described
Setting: not described
No. of participants: 8: 4 in streptokinase group, 4 in heparin alone group
Age (mean ± SD): 51 ± 22.89 in streptokinase group, 46.5 ± 10.28 in heparin alone group
Sex: 3 males, 1 female in streptokinase group; 2 males, 2 females in heparin alone group
Inclusion criteria: patient age ≥ 15 years; previously healthy patients; PE diagnosis sustained by high clinical suspicion; PE proven by high‐probability V/Q lung scan, suggestive echocardiogram, or radionuclide venogram; massive PE, defined as > 9 obstructed segments on V/Q lung scan with or without cardiogenic shock, < 9 obstructed segments on V/Q lung scan but with RVD, extensive DVT, or both; symptoms or signs of PE within 14 days after onset of symptoms
Exclusion criteria: previous PE; < 3 segmental defects on V/Q lung scan, with normal echocardiogram and without DVT; absolute contraindication for thrombolytic therapy
Interventions Treatment group: streptokinase group received 1,500,000 IU of SK over 1 hour by the peripheral vein, followed by a bolus of 10,000 IU of heparin, then a constant infusion of 1000 IU/h of heparin titrated to a partial thromboplastin time of 2.0 to 2.5 times control
Control group: heparin group followed the same regimen, but without streptokinase
Length of follow‐up: no information provided
Outcomes Mortality
Notes This study had previously been excluded and was reassessed and included in this update according to strict criteria for included studies provided in the Cochrane Handbook for Systematic Reviews of Interventions
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk "The patients were randomised to streptokinase followed by heparin or to heparin alone by withdrawal of a sealed envelope from a closed box that initially contained 40 envelopes numbered consecutively from 1 to 40; even numbers were assigned to SK plus heparin and odd numbers to heparin"
Allocation concealment (selection bias) Unclear risk No information provided
Blinding (performance bias and detection bias) 
 All outcomes Unclear risk No information provided
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No missing data
Selective reporting (reporting bias) Unclear risk No information provided
Other bias High risk Small sample size; baseline imbalanced (especially for onset of PE ‐ 2.5 hours in thrombolytics group vs 34.75 hours in heparin group)