Nielsen 1994.
| Methods | Randomised, open‐label trial | |
| Participants | Number; 16 participants 9 received anticoagulant treatment and 7 received no anticoagulant treatment Age: not specified for participants with distal DVT Gender: not specified for participants with distal DVT |
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| Interventions | UFH/phenprocoumon for 3 months vs no anticoagulation. Intervention: sodium heparin administered intravenously. Treatment initiated by bolus injection of 10,000 IU, followed by continuous infusion (20,000 IU of heparin in 500 mL of 5% dextrose) with APTT target at 1.5–2.5. Phenprocoumon was given from the 3rd day. Heparin treatment was continued for ≥ 6 days or until INR had reached 2.0–4.3. Control: participants were treated with phenylbutazone 200 mg 3 times at the day of admission and then 100 mg 3 times daily for the following 9 days. All participants were actively mobilised from the day of admission and wore graduated compressing stockings. |
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| Outcomes | Propagation or development of new VTE | |
| Notes | People with clinical symptoms of PE were excluded. Study protocol involved 90 participants with DVT; 16 were diagnosed with distal DVT. Funding/support: not reported. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Insufficient information about sequence generation process. |
| Allocation concealment (selection bias) | Low risk | Random 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. |