The REACH trial is a prospective multicenter double-blind randomized placebo-controlled trial with blinded end-point adjudication. Participants are randomized (1:1) to receive either sodium aescinate or matching placebo (0.9% saline). The primary outcome is the absolute volume of PHE evaluated based on brain CT image on day 14 after ICH.
The REACH trial is a prospective multicenter double-blind randomized placebo-controlled trial with blinded end-point adjudication. Participants are randomized (1:1) to receive either sodium aescinate or matching placebo (0.9% saline). The primary outcome is the absolute volume of PHE evaluated based on brain CT image on day 14 after ICH. Functional outcome is assessed face to face at 3-month after onset. Meanwhile, central telephone follow-up determines functional outcomes at 3-month after onset. Brain imaging (CT) is performed as part of routine care prior to enrolment. A research CT scan is performed after 24h of symptom onset to assess hematoma expansion; a second research CT scan is performed at 72 hours after onset to assess brain swelling and dynamic change of PHE. The study was approved by the ethics committee of the Beijing Tiantan hospital. The study is conducted according to GCP guidelines.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
300
sodium Aescinate 10mg in 250ml sodium chloride 0.9% infusion bag intravenously once daily for 10 days.
250ml sodium chloride 0.9% infusion bag intravenously once daily for 10 days.
Absolute edema volume on day 14 after ICH
Absolute edema volume is based on brain CT image
Time frame: on day 14 after ICH
Relative edema volume on day 14 after ICH
Relative edema volume is based on edema volume divided by hematoma volume
Time frame: on day 14 after ICH
Absolute edema volume and relative edema volume on 24 ±12 hour and 72±12 hour after ICH symptom onset
absolute edema volume is based on brain CT image；relative edema volume is based on edema volume divided by hematoma volume
Time frame: on 24±12 hour and 72±12 hour after ICH symptom onset
Cytotoxic edema on 72 ±12 hour after ICH symptom onset
Cytotoxic edema is based on brain MRI image
Time frame: on 72 ±12 hour after ICH symptom onset
Dynamic changes of serum IL-x levels(ng/ml) within 14 days of symptom onset
The purpose is to evaluate dynamic changes of serum inflammatory factor levels within 14 days of symptom onset
Time frame: within 14 days of symptom onset
Dynamic changes of serum NF-kB levels(ug/ml) within 14 days of symptom onset
The purpose is to evaluate dynamic changes of serum inflammatory factor levels within 14 days of symptom onset
Time frame: within 14 days of symptom onset
Dynamic changes of serum TNF levels(ng/ml) within 14 days of symptom onset
The purpose is to evaluate dynamic changes of serum inflammatory factor levels within 14 days of symptom onset
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Time frame: within 14 days of symptom onset
Dynamic changes of serum MMPs levels(ug/ml) within 14 days of symptom onset
The purpose is to evaluate dynamic changes of serum inflammatory factor levels within 14 days of symptom onset
Time frame: within 14 days of symptom onset
Dynamic changes of serum VEGF levels(pg/ml) within 14 days of symptom onset
The purpose is to evaluate dynamic changes of serum inflammatory factor levels within 14 days of symptom onset
Time frame: within 14 days of symptom onset
Dynamic changes of serum EPO levels(ng/ml) within 14 days of symptom onset
The purpose is to evaluate dynamic changes of serum inflammatory factor levels within 14 days of symptom onset
Time frame: within 14 days of symptom onset
Dynamic changes of serum angiopoietin-1 levels(pg/ml) within 14 days of symptom onset
The purpose is to evaluate dynamic changes of serum inflammatory factor levels within 14 days of symptom onset
Time frame: within 14 days of symptom onset
Change of neurological dysfunction within 14 days of symptom onset
Change of neurological dysfunction within 14 days of symptom onset is based on National institute of health stroke scale(NIHSS）14d-NIHSS enrollment.（The minimum and maximum values of NIHSS is 0 and 42,respectively, higher scores mean a worse outcome.）
Time frame: within 14 days of symptom onset
Cognition（MMSE) at 14 days of symptom onset
Cognition is based on Mini-mental State Examination（MMSE）. （The minimum and maximum values of MMSE is 0 and 30,respectively, higher scores mean a better outcome. ）
Time frame: at 14 days of symptom onset
Cognition（MoCA) at 14 days of symptom onset
Cognition is based on Montreal Cognitive Assessment（MoCA）. （The minimum and maximum values of MoCA is 0 and 30,respectively, higher scores mean a better outcome.）
Time frame: at 14 days of symptom onset
Dependency at 90±7 days after onset
Dependency at 90±7 days after onset Dependency is based on Modified Rankin Scale（mRS ）. （The minimum and maximum values of mRS is 0 and 5,respectively, higher scores mean a worse outcome.）
Time frame: at 90±7 days after onset
Quality of life at 90±7 days after onset
Quality of Life is based on five-level version of EuroQol Five Dimensions Questionnaire（EQ-5D-5L）. （The scale mainly contains 5 dimensions, including mobility, self-care ability, ability to perform daily activities, pain or discomfort, and anxiety or depression. Each dimension is divided into 5 levels: no difficulty, mild difficulty, moderate difficulty, severe difficulty, extreme difficulty or inability）
Time frame: at 90±7 days after onset
Cognition（MMSE） at 90±7 days after onset
Cognition is based on Mini-mental State Examination（MMSE）. （The minimum and maximum values of MMSE is 0 and 30,respectively, higher scores mean a better outcome. ）
Time frame: at 90±7 days after onset
Cognition（MoCA） at 90±7 days after onset
Cognition is based on Montreal Cognitive Assessment（MoCA）. （The minimum and maximum values of MoCA is 0 and 30,respectively, higher scores mean a better outcome.）
Time frame: at 90±7 days after onset
adverse events(AEs) and serious adverse events（SAEs) through 14 days
Any complications associated with sodium aescinate treatment (e.g. allergy, gastrointestinal complications, bleedings, thrombotic, or infectious complications) were defined as adverse events (AEs). SAEs are defined as any untoward medical occurrence or effect that at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity. SAEs and safety endpoints are reported in line with expedited reporting regulations and then adjudicated by an independent panel.
Time frame: up to 14 days
all serious adverse events(SAEs) throughout the study follow-up period up to 3 months
SAEs are defined as any untoward medical occurrence or effect that at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity.
Time frame: up to 3 months