Schulman 1995.
| Methods | Randomised, open‐label trial | |
| Participants | Number: 347 participants 176 participants received anticoagulation treatment for 6 weeks and 171 participants received anticoagulation treatment for 6 months Age: not stratified by distal thrombosis Gender: not stratified by distal thrombosis |
|
| Interventions | VKA for 6 months vs 6 weeks The initial treatment with UFH or LMWH administered intravenously or subcutaneously for ≥ 5 days, until a prothrombin time within the target range had been achieved. Participants with DVT were provided with a graded compression stocking and instructed to wear it on the affected leg during the day for ≥ 1 year. Oral anticoagulation with warfarin sodium or dicumarol was usually started at the same time as heparin. Oral anticoagulation was targeted to an INR of 2.0–2.85. |
|
| Outcomes | Recurrent VTE at 2 years | |
| Notes | People with previous VTE or cancer were excluded. The data came from a larger study which included people with proximal and distal DVT. We only had stratified data for the outcome recurrent VTE at 2 years. Funding/support: quote: "Supported by grants from Swedish Heart Lung Foundation, the Swedish Society of Medicine, the Karolinska Institute, Skandia, Trygg–Hansa, Triolab, Karolinska Hospital, Nycomed, and Stago." |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated allocation. |
| Allocation concealment (selection bias) | Low risk | Central allocation. |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Open‐label study. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | No blinding of outcome assessment but the review authors judged that the outcome measurement was unlikely to be influenced by lack of blinding. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing data. |
| Selective reporting (reporting bias) | Low risk | Published report included all expected outcomes. |
| Other bias | Low risk | Study appeared free of other sources of bias. |