Overview

Reducing Edema After intraCerebral Hemorrhage

Status:
Not yet recruiting
Trial end date:
2025-03-31
Target enrollment:
0
Participant gender:
All
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 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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Beijing Tiantan Hospital
Criteria
Inclusion Criteria:

1. Patients aged between 18-80 years old;

2. Spontaneous ICH confirmed by cranial CT;

3. Time from onset to randomization within 24 hours;

4. Superatentorial ICH;

5. Hematoma volume between 10-30 ml (calculated using ABC/2 method);

6. Glasgow coma scale (GCS) > 9 on admission;

7. informed and consent.

Exclusion Criteria:

1. 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);

2. ICH secondary to traumaļ¼›

3. Primary intraventricular hemorrhage (IVH);

4. Signs of herniation, such as progressive decline in consciousness, decreased or
disappearance of pupillary light reflection, bilateral pyramidal tract signs, etc;

5. Other serious, advanced or terminal illness such that life expectancy is less than one
year (e.g. advanced metastatic cancer);

6. Severe cardiac insufficiency (NYHA class III or IV);

7. High-risk arrhythmia, such as sick sinus syndrome, second or third degree
atrioventricular block, bradycardia-related syncope without a pacemaker, etc;

8. 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;

9. Severe renal insufficiency: Severe renal insufficiency is defined as creatinine
greater than 1.5 times the upper limit of normal;

10. History of severe asthma or chronic obstructive pulmonary disease (COPD);

11. History of coagulopathy or systemic bleeding;

12. A thrombocyte count below <100 x 10^9/L or leukocytosis < 2 x 10^9/L on admission;

13. 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;

14. Patients with preexisting disability of a modified Rankin Scale (mRS) score greater
than 2 prior to ICH;

15. Unable to understand the research procedures and/or complete follow-up due to mental
illness, cognitive impairment, affective disorder, etc;

16. Women of childbearing potential, pregnant, or breastfeeding at randomization;

17. Contraindication to sodium aescinateļ¼›

18. Participate in other clinical studies within 3 months or are participating in other
clinical studies.