Orken 2009.
Study characteristics | ||
Methods |
Design: parallel group RCT Setting: inpatient admissions to Sisli Etfal Education and Research Hospital, Department of Neurology in Turkey Dates: January 2006 ‐ March 2008 |
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Participants |
Sample size: 75 participants Diagnosis: ICH Inclusion criteria
Exclusion criteria
Age (years, mean (SD)): 68 ± 11 (intervention) 66 ± 10 (comparator) Sex: 56% female (intervention), 22% female (comparator) |
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Interventions |
Intervention: subcutaneous LMWH (enoxaparin sodium 40mg/d) (39 participants) Comparator: long compression stockings (36 participants) |
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Outcomes |
Primary outcome: not described Secondary outcomes: not described Outcomes
Duration of follow‐up: 21 days |
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Notes |
Declarations of interest: not described Sources of funding: not described Other: it is not clear whether 4 patients who were excluded because of "death before 7th day investigations" were excluded before or after randomisation |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Randomisation was said to be done, "after the first 48 hours according to the order of hospital admission dates" which seems to be predictable and at high risk of bias |
Allocation concealment (selection bias) | High risk | Randomisation was said to be done, "after the first 48 hours according to the order of hospital admission dates" which seems to be predictable and at high risk of bias |
Blinding of participants and personnel (performance bias) All outcomes | High risk | The intervention and comparator could not be blinded |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "All radiologic material was prospectively evaluated by 2 radiologists ... who were blinded to the clinical findings and cranial CTs of the patients" The methods did not explicitly state that the radiologists were also blinded to treatment allocation |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Outcome data were complete |
Selective reporting (reporting bias) | Low risk | All outcomes planned in the Methods section were reported in full in the Results section. Additionally, most expected outcomes of interest were reported in this study |