Pan 2007.
Methods | RCT | |
Participants | 108 participants with acute ischaemic stroke Time of randomisation after stroke onset: between 2 hours and 6 days Treatment: 54 participants at randomisation (52% male, age range 38 to 78 years) and all completed the trial Control: 54 participants at randomisation (55% male, age range 46 to79 years) and all completed the trial |
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Interventions | Treatment: buflomedil hydrochloride (200 mg, ivgtt, daily, 15 days) + control intervention Control: batroxobin (DF‐521) (d1: 10 batroxobin units ivgtt, daily; d3: 5 batroxobin units, ivgtt; d5: 5 batroxobin units, ivgtt) + usual medical care |
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Outcomes | Time of outcome assessment: by the end of 15‐day treatment Death by the end of treatment CSS Haemorheological indices (whole blood viscosity, platelet aggregation rate, fibrinogen, platelet count, prothrombin time) Adverse events |
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Notes | Combination of buflomedil with batroxobin Funding: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Randomised" but did not report the methods of randomisation |
Allocation concealment (selection bias) | Unclear risk | Insufficient information was reported to permit judgement |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Interventions used in the 2 groups were visibly different |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | The trial did not address this outcome |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing outcome data |
Selective reporting (reporting bias) | Unclear risk | The protocol was not available. Insufficient information to permit judgement |