Elliot 1979.
| Methods | A prospective, controlled, randomised, comparative study to compare conventional full dose heparin and streptokinase (Kabikinase) | |
| Participants | Country: South Africa Total randomised: 51 (strep 26, hep 25) Sex: Male (17) and female (34) Mean age hep group: 51 years; strep group: 48 years Inclusion criteria: proximal vein thrombosis diagnosed by bilateral ascending phlebograph and less than 8 days clinical history of DVT Exclusion criteria: any surgery within 7 days or neurosurgical within 2 months, pregnancy, menstruation, haemorrhagic diatheses, diastolic blood pressure of 110 mmHg, suspected or know bleeding lesions, cerebrovascular accident within 6 months, recent streptococcal infection, previous streptokinase therapy within 6 months, liver or renal disease 2 patients in strep group had axillary vein thrombosis |
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| Interventions | Treatment: 100 mg of hydrocortisone 15 mins prior to first streptokinase dose and repeated 6 hourly for duration of strep treatment. Strepokinase (Kabikinase) loading dose of 600,000 U given by infusion over a period of 30 mins. Then 100,000 U hourly for 3 days by infusion pump. Then heparin for 4 days dose adjusted to maintain Lee‐White clotting time to at least 2.5 ‐ 3 normal Control: At diagnosis 10,000 U of heparin given by iv injection. The 10,000 U iv 6 hourly using constant infusion pump. Dose adjusted to maintain Lee‐White clotting time to at least 2.5 ‐ 3 normal Treatment continued for 7 days 30 mg warfarin given as a loading dose to both groups 36 hours before heparin therapy terminated, warfarin continued for 8 weeks, dose adjusted to maintain pro‐thrombin index 40 ‐ 60 per cent All participants bed rest for duration, foot of bed raised by 60 cm, elastic support provided |
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| Outcomes | Mortality, complete lysis, bleeding, PE, valve function, PTS symptoms 6‐33 months (mean 19 months) | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | no details given |
| Allocation concealment (selection bias) | Unclear risk | no details given |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | no details given but judged low risk as outcome assessment well described |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | "..all radiographs were assessed on a blind basis" |
| 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 |