Elsharawy 2002.
Study characteristics | ||
Methods | Allocation: random Single blind Exclusions after randomisation ‐ nil Losses to follow‐up ‐ nil |
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Participants | Country: Egypt Participants: 35 Age: < 70 years Sex: Male and female Inclusion criteria: iliofemoral venous thrombosis confirmed by duplex or venography duration < 10 days; life expectancy > 6 months Exclusion criteria: surgery < 14 days; previous CVA/CNS disease; GI bleed < 1 year; BP > 180/100; pregnancy etc.; other contraindications to thrombolysis not explicitly described |
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Interventions | Treatment: catheter‐directed thrombolysis with streptokinase using popliteal approach. Pulse spray given then vein assessed using contrast every 15 minutes. In 1 hour 1 million U given. Followed by low dose infusion 100,000 U/hour, assessed every 12 hours. Stopped when complete lysis achieved, no progress in 12 hours or complication occurred. Followed by anticoagulation Control: heparin IV bolus 5000 U, then adjusted continuous infusion. Warfarin begun the same evening Co treatment: none described |
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Outcomes | 1 week: clot lysis; bleeding; mortality; PE 6 months: clot lysis; venous function |
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Funding | Not reported | |
Declaration of interests | Not reported | |
Notes | Catheter‐directed thrombolysis, as distinct from systemic or loco‐regional | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "...computer designated cards assigning patients to either groups" |
Allocation concealment (selection bias) | Unclear risk | Not described |
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 | " ..panel unaware of the sequencing of the studies or if images were obtained at baseline, 24 ‐ 48 hours after randomisation or before discharge" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Complete data available |
Selective reporting (reporting bias) | Low risk | Pre‐specified outcomes reported |
Other bias | Low risk | None |