Status:
UNKNOWN
Reducing Edema After intraCerebral Hemorrhage
Lead Sponsor:
Beijing Tiantan Hospital
Conditions:
Edema Brain
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
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 ...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Patients aged between 18-80 years old;
- Spontaneous ICH confirmed by cranial CT;
- Time from onset to randomization within 24 hours;
- Superatentorial ICH;
- Hematoma volume between 10-30 ml (calculated using ABC/2 method);
- Glasgow coma scale (GCS) \> 9 on admission;
- informed and consent.
Exclusion
- Suspected secondary cause of ICH (e.g. aneurysm, vascular malformation, neoplasia, cerebral venous thrombosis, hemorrhagic transformation of recent ischemic stroke, thrombolysis or endovascular treatment, anticoagulation, et al);
- ICH secondary to trauma；
- Primary intraventricular hemorrhage (IVH);
- Signs of herniation, such as progressive decline in consciousness, decreased or disappearance of pupillary light reflection, bilateral pyramidal tract signs, etc;
- Other serious, advanced or terminal illness such that life expectancy is less than one year (e.g. advanced metastatic cancer);
- Severe cardiac insufficiency (NYHA class III or IV);
- High-risk arrhythmia, such as sick sinus syndrome, second or third degree atrioventricular block, bradycardia-related syncope without a pacemaker, etc;
- Severe liver insufficiency; severe liver insufficiency is defined as ALT \> 2 times the upper limit of normal or AST greater than 2 times the upper limit of normal;
- Severe renal insufficiency: Severe renal insufficiency is defined as creatinine greater than 1.5 times the upper limit of normal;
- History of severe asthma or chronic obstructive pulmonary disease (COPD);
- History of coagulopathy or systemic bleeding;
- A thrombocyte count below \<100 x 10\^9/L or leukocytosis \< 2 x 10\^9/L on admission;
- Patients who plan to undergo surgical intervention before the first administration, including but not limited to hematoma removal (including minimally invasive and conventional surgery), decompressive craniectomy, hematoma aspiration, and ventricular puncture external drainage;
- Patients with preexisting disability of a modified Rankin Scale (mRS) score greater than 2 prior to ICH;
- Unable to understand the research procedures and/or complete follow-up due to mental illness, cognitive impairment, affective disorder, etc;
- Women of childbearing potential, pregnant, or breastfeeding at randomization;
- Contraindication to sodium aescinate；
- Participate in other clinical studies within 3 months or are participating in other clinical studies.
Key Trial Info
Start Date :
March 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2025
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT05263167
Start Date
March 15 2022
End Date
March 31 2025
Last Update
March 21 2022
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