Removing Blood Stasis Therapy In Treating Ultra-acute Intracerebral Hemorrhage:A Multi-center Control LED Randomized Clinical Trial

BackgroundHypertensive intracerebral hemorrhage(HICH)is one of the most devastating forms of stroke.Currently,there is no specific therapy for HICH.However,the therapy of removing blood stasis(RBS)are widely and efficiently used in Chinese hospitals to treat HICH based on the TCM theory of 'the blood flow outside the vessels is the blood stasis',which has not been proved by high-level evidence-based medical researches.Therefore,it is necessary to evaluate the safety and effect for the patients of ultra-acute intracerebral hemorrhage with the treatment of RBS therapy by rigorously designed randomized controlled trials with scientific methods.ObjectiveTo evaluate the safety and effect for the patients of ultra-acute intracerebral hemorrhage with the treatment of removing blood stasis therapy and explore the factors related to hematoma enlargement and poor prognosis.MethodsA multicenter,three-group,prospective,randomized,double-blinded and placebo-controlled clinical trial.Stratified block randomization is undertaken using a sequentially numbered and opaque envelope.Patients with hypertensive intracerebral hemorrhage(HICH)confirmed by CT scan from 14 research centres are enrolled within 6 hours from the onset.All subjects will be randomized to the three groups(A&B&C)and take medicine respectively within 6 hours of ictus,subsequently taking twice a day by oral or nasogastric tube for 10 days.A followup will be conducted in 3 months to evaluate their recorvery.Primary outcome is the incidence of poor prognosis defined by mRS = 5 on the 90th day.Secondary outcomes include:The recovery degree of neurological deficit,ability of daily living,disability,the rate of hematoma enlargement,and serious adverse events,etc.Results324 participants from 5589 screening patients with ICH were included finaly,respectively,group A with 105 cases,group B with 110 cases,group C with 108 cases.The study shows that the incidence of poor prognosis among the three groups has no difference(P>0.05).There are also no difference in the change of NIHSS,BI,mRS,and in the rate of hematoma enlargement,disability and mortality by 24h,10th day and 90th days(P>0.05).However there are significantly different in the incidence of adverse event among the three groups in 90 days(P<0.05),suggesting that the incidence of adverse event in group C is higher than others.Multivariate analysis indicates that no independent risk factors have been found related to hematoma enlargement and poor prognosis in the study.Conclusion1.It may not reduce the incidence of poor prognosis and can not improve the neural function with removing blood stasis treatment in ultra-acute intracerebral hemorrhage.However,it may increase the incidence of adverse event.2.Multivariate analysis indicates that no independent risk factors have been found related to hematoma enlargement and poor prognosis in the study.3.It suggests that the herbal medicine of removing blood stasis such as Hirudo and Tabanus should be forbidden to patients with ultra-acute intracerebral hemorrhage,for fear of worsening condition.