Orken 2009.
| Methods | RCT Duration: 21 days Design: parallel Setting: inpatient unit in Turkey Dates: between January 2006 and March 2008 |
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| Participants | 75 participants Diagnosis: intracerebral haemorrhage Diagnosis model: cranial CT Eligibility criteria: diagnosis of primary ICH Exclusion criteria: early death before heparin treatment, death before 7th day investigations, secondary ICH due to aneurysm, arteriovenous malformations, traumas and tumours. Excessive anticoagulation (INR > 2.0). Contraindication to contrast agents Age (years, mean (SD)): 68.1 (11.98) (intervention group) 66.08 (9.55) (control group) Sex: 56% female (intervention group), 22% female (control group) Additonal details: mean National Institutes of Health Stroke Scale scores on admission for the LMWH group was 9.74 ± 6.06 and for the compression stocking group was 8.61 ± 6.87. 32/39 participants in the LMWH group and 29/36 participants in the compression stocking group had hypertension identified as a risk factor for ICH. 11 participants from the LMWH group and 6 from the compression stocking group had had a prior cerebrovascular accident |
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| Interventions | 1. Enoxaparin sodium 48 mg/day (n = 39) 2. Compression stocking control (n = 36) Treatment began after the first 48 hours from hospital admission |
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| Outcomes | Haematoma enlargement at 72 hours, 7 days and 21 days. Haematoma enlargement was defined as an increase in volume of > 33% or 12.5 mL Systemic bleeding complications DVT or PE based on CTPA and bilateral venous Doppler at 7 days |
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| Notes | Conflicts of interest and sources of funding were not described | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | The method of randomisation not described |
| Allocation concealment (selection bias) | Unclear risk | Allocation concealment not described |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding not possible due to 1 group receiving a subcutaneous injection and the other group receiving compression stockings |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | "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 |
| Other bias | Unclear risk | To our knowledge this study was not prospectively registered |
CT: computed tomography CTPA: CT pulmonary angiography DVT: deep vein thrombosis ICH: intracerebral haemorrhage INR: International normalised ratio LMWH: low‐molecular‐weight heparin PE: pulmonary embolism RCT: randomised controlled trial SD: standard deviation