Arneson 1978.
| Methods | Allocation: random Single blind Exclusions after randomisation: 1 Loss to follow‐up: nil |
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| Participants | Country: Norway Participants: 43 Age: < 70 years Sex: Male and female Inclusion criteria: inpatients with venographically confirmed DVT extending proximally beyond the calf < 5 days duration Exclusion criteria: bleeding dysfunction; surgery within 7 days; GI/GU bleeding; stroke; diastolic BP > 120 mmHg; hypertensive retinopathy grade 3 ‐ 4; renal/hepatic insufficiency; pregnancy; malignancy; age > 70 |
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| Interventions | Treatment: streptokinase 250,000 U loading IV, then 100,000 IU/hour IV 72 ‐ 96 hours Control: heparin 15,000 IU IV bolus, 30,000 IU infusion IV 72 ‐ 90 hours Co‐treatment: hydrocortisone 100 mg IV, then prednisolone 10 mg three times daily during streptokinase infusion. Warfarin begun after streptokinase along with heparin until warfarin effective In control group, warfarin begun after 72 ‐ 90 hours with continuation of heparin until warfarin effective |
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| Outcomes | 21 days: mortality; PE; major bleeding; clot lysis 6 years: mortality; recurrent DVT; post‐thrombotic syndrome; leg ulceration |
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| Notes | 40 randomised, 1 excluded as diagnosis of DVT in error 3 patients included who were not randomised, 2 streptokinase, 1 control | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "...performed by our statistician on the basis of random numbers" |
| Allocation concealment (selection bias) | Low risk | " ...allocation to the treatment groups was performed by using sealed envelopes" |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | not possible due to intervention but judged low risk as outcome assessment well described |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | "the radiologic evaluation was done without knowledge of the treatment given" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | no missing data |
| Selective reporting (reporting bias) | Low risk | all outcomes reported |
| Other bias | Low risk | none |