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) |