Schweizer 1998.
| Study characteristics | ||
| Methods | Allocation: random Single blind Exclusions after randomisation: 2 Losses to follow‐up: 1 |
|
| Participants | Country: Germany Participants: 69 Age: 22 to 58 years Sex: Male and female Inclusion criteria: venographically confirmed DVT of leg duration < 7 days Exclusion criteria: PE; calf vein thrombosis; recurrent DVT; GI/GU bleed; inflammatory bowel disease; acute pancreatitis; surgery within 4 weeks; IM injection within 10 days; hypertensive retinopathy grade 3 or 4; intracerebral disease; cerebral surgery or trauma within 3 months; malignancy not in remission; diabetic retinopathy stage 3 or 4; renal or hepatic failure; bleeding dysfunction; pregnancy, lactation, delivery within 20 days |
|
| Interventions | Treatment: (2 groups) tPA 20 mg IV into pedal vein over 4 hours each day for 7 days. Heparin IV given concomitantly, with adjustment Urokinase 100,000 IU/hr IV into pedal vein continuously for 7 days. Heparin IV for 7 days. Plasminogen monitored Warfarin from day 7 to 12 months Control: heparin IV, adjusted for 7 days Co‐treatment: bed rest and compression treatment. Warfarin from day 7‐ 12 months in treatment groups. Warfarin begun immediately, for 12 months in control group. Compression for 12 months for all patients |
|
| Outcomes | 7 days: bleeding; clot lysis (no results for control group) 1 year: post‐thrombotic syndrome |
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| Funding | Not reported | |
| Declaration of interests | Not reported | |
| Notes | Loco‐regional thrombolysis. 2 patients excluded due to bleeding, 1 tPA, 1 urokinase. 1 lost to follow‐up from control group | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "...designed by a biometrician who was not involved in the study" |
| Allocation concealment (selection bias) | Unclear risk | No details given |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Not described but judged unlikely to influence outcome assessment as well described |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | "...evaluated by an independent radiologist who was unaware of the treatment the patients had received" |
| 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 |