Reducing Edema After intraCerebral Hemorrhage

NCT ID: NCT05263167

Last Updated: 2022-03-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-15
• Study Completion Date: 2025-03-31

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 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.

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 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.

Conditions

Edema Brain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

sodium aescinate group

Trial treatment is administered as sodium Aescinate 10mg in 250ml sodium chloride 0.9% infusion bag intravenously once daily for 10 days.

Group Type: EXPERIMENTAL

Sodium Aescinate

Intervention Type: DRUG

sodium Aescinate 10mg in 250ml sodium chloride 0.9% infusion bag intravenously once daily for 10 days.

placebo group

Trial treatment is administered as 250ml sodium chloride 0.9% infusion bag intravenously once daily for 10 days.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

250ml sodium chloride 0.9% infusion bag intravenously once daily for 10 days.

Interventions

Sodium Aescinate

sodium Aescinate 10mg in 250ml sodium chloride 0.9% infusion bag intravenously once daily for 10 days.

Intervention Type: DRUG

Placebo

250ml sodium chloride 0.9% infusion bag intravenously once daily for 10 days.

Intervention Type: DRUG

Other Intervention Names

Sodium Aescinate for Injection; 0.9% sodium chloride injection

Eligibility 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 trauma；

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 aescinate；

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tiantan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ji

Role: PRINCIPAL_INVESTIGATOR

Beijing Tiantan Hospital

Central Contacts

Hao Feng

Role: CONTACT

fenghao57865578@163.com

13811059362

Other Identifiers

100999

Identifier Type: -

Identifier Source: org_study_id