Dickmann 1988.
| Study characteristics | ||
| Methods |
Design: parallel group RCT Setting: inpatient admissions to the neurology unit of one hospital in Göttingen, Germany Dates: not described |
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| Participants |
Sample size: 46 participants Diagnosis: ICH Inclusion criteria: diagnosis of ICH by CT with onset 24 hours before admission Exclusion criteria: bleeding diathesis, diastolic blood pressure higher than 120 mmHg, and deep coma with clinical signs of brain herniation Age (years, mean (SD)): 62 (SD not described) (intervention group), 60 (SD not described) (comparator group) Sex: 52% female (intervention group), 48% female (comparator group) |
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| Interventions |
Intervention: 5000 units of heparin administered subcutaneously 8‐hourly starting at day 4 (23 participants) Comparator: 5000 units of heparin subcutaneously 8‐hourly starting at day 10 (23 participants) Both groups had the same treatment otherwise, with compression stockings and physical treatment |
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| Outcomes |
Primary outcome: not specified Secondary outcomes: not specified Outcomes: rebleeding occurring during the trial period; thrombosis of abdomen or legs at day 2 and day 10; pulmonary embolism at day 10; death Duration: the duration of follow‐up is not specified, but is assumed to be 10 days |
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| Notes |
Declations of interest: not described Sources of funding: not described Rebleeding was not defined by the authors of this study |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not described |
| Allocation concealment (selection bias) | Unclear risk | Not described |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | This was an open trial, comparing two timings of heparin |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "All scintigrams were read by the same blinded investigators" |
| 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 |