Optimal intervention time and risk of the activating blood and removing stasis method in acute cerebral hemorrhage patients: A randomized placebo-controlled trial

INTRODUCTION: Stroke is the leading cause of disability-adjusted life years in neurological diseases and has become one of the top 3 fatal diseases in the world. Cerebral hemorrhage accounts for approximately 18% to 24% of all strokes in Asian countries. Cerebral hemorrhage is one of the most destructive subtypes of stroke and has high morbidity and mortality. Based on the current research, it has been confirmed that neither surgical treatment nor current drug treatment is the most preferred treatment. Traditional Chinese medicine (TCM) is increasingly being used to treat cerebral hemorrhage, and the activating blood and removing stasis (ABRS) method has received more attention. At present, there is still a lack of high-quality clinical research on the treatment of acute cerebral hemorrhage. METHOD: We designed a multicenter, prospective, randomized, double-blind, placebo-controlled clinical trial. We aim to recruit 312 cerebral hemorrhage patients aged 18 to 80 years within 24 to 72 hours after onset. In addition to routine treatment, participants will randomly receive ABRS granules or placebo for 14 days. Those enrolled within 24 to 48 hours after onset will enter strata A, and those enrolled within 49 to 72 hours (including 48–49 hours) after onset will enter strata B. The strata sample size ratio will be 1:1. The primary outcome is the disability degree (modified Rankin Scale score, mRS) at 6 months after onset. The secondary outcomes include the percentage of hematoma enlargement after treatment, Barthel index (BI), National Institutes of Health stroke scale (NIHSS) score, mortality rate, all-cause mortality rate, TCM stroke syndrome evaluation scale score, and adverse events. DISCUSSION: The study is expected to confirm the safety and effect of acute cerebral hemorrhage within 24 to 72 hours treated with the ABRS method and to determine the optimal time for intervention in this period. TRIAL REGISTRATION NUMBER: ChiCTR1900022627