Partsch 1996.
Methods | Study design: Randomised clinical trial (blinding not reported). Method of randomisation: not stated. No. of exclusions post‐randomisation: not stated. Lost to follow up: not stated. |
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Participants | Country: Austria. Setting: Hospital. No. of participants: 140; 76 once daily group, 64 twice daily group. Age (mean): 69.13 ± 17.06 years once daily group; 72.21 ± 13.21 years twice daily group. Gender: 28 M : 48 F once daily group; 34 M : 30 F twice daily group. Inclusion criteria: Consecutive patients presented with DVT extending into the iliofemoral segment diagnosed by duplex ultrasonography. Exclusion criteria: previous fibrinolytic treatment; thrombectomy; complete bed rest for > 3 days within 36 hours of admission to hospital; been previously immobilised in other departments as a result of surgery, trauma or internal diseases because of inability to ambulate; pregnancy. |
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Interventions | Fragmin administered 200 IU/kg once daily or 100 IU/kg twice daily started immediately after randomisation for at least 7 days. Coumarin treatment was initiated approximately 10 days after diagnoses and continued for at least 3 months. | |
Outcomes | Decrease in frequency of PE as judged by the difference between the second V/Q scan and the initial baseline scan, major and minor bleeding, and mortality. The definition of major bleeding was not specified, but the one that occurred was characterised as "requiring 2 U of blood transfusion, gastrointestinal". | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |