Ugurlu 2002.
| Study characteristics | ||
| Methods | Prospective study to compare efficacy and safety of low dose, slow infusion thrombolysis Randomised |
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| Participants | Country: Turkey Age: 18 to 70 years Number: 97, 50 low dose strep, 47 hep June 1995 to May 1999 Sex: Male and female Informed consent Baseline characteristics similar Inclusion criteria: DVT confirmed with high resolution colour duplex Exclusion criteria: history of stroke, intracranial haemorrhage, major GI, urological ir genital haemorrhage, major trauma or surgery within 20 days, hypertension, known bleeding diathesis, post partum, nursing or pregnant women |
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| Interventions | Strepokinase group: Methylprednisone 250 mg IV with IV antihistaminic prior to 250,000 U given in 30 mins via forearm vein, then infusion of 100,000 U/hour. Infusion stopped when a dose of 1,500,000 U. Then heparin according to prothrombin and partial thromboplastin times and duplex study done. Urokinase administered in 2 patients who had severe allergic reaction to strep ‐ bolus of 100,000 U then infusion of 100,000 U per hour for a total dose of either 1,500,000 or 3,000,000 U Heparin group: bolus of 5000 U, then infusion of 1‐1500 U/hr. Dose adjusted according to the activated partial thromboplastin time Both groups: bed rest and elevation, coumadin started 48 hours later according to prothrombin times, INR of 2 ‐ 3 |
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| Outcomes | Venous flow, clinical assessment, haemorrhagic complications, allergic reaction | |
| Funding | Not reported | |
| Declaration of interests | Not reported | |
| Notes | Recurrent DVT included (30% each group) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Randomised number table" |
| Allocation concealment (selection bias) | Unclear risk | Not mentioned |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Not possible but judged low risk as outcome assessment well described |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | "...initial and post‐treatment duplex studies preformed by same radiologist unaware of groups.." |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | All accounted for |
| Selective reporting (reporting bias) | Low risk | All outcomes reported |
| Other bias | Low risk | None |