Reducing Edema After intraCerebral Hemorrhage

NCT05263167 | Unknown Phase 4 DMC

• 1 other identifier: 100999
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Edema Brain

Keywords

edema; intracerebral hemorrhage; sodium aescinate

Outcome Measures

Primary Outcomes (1)

• Absolute edema volume on day 14 after ICH

  Absolute edema volume is based on brain CT image

  on day 14 after ICH

Secondary Outcomes (19)

• Relative edema volume on day 14 after ICH

  on day 14 after ICH

• Absolute edema volume and relative edema volume on 24 ±12 hour and 72±12 hour after ICH symptom onset

  on 24±12 hour and 72±12 hour after ICH symptom onset

• Cytotoxic edema on 72 ±12 hour after ICH symptom onset

  on 72 ±12 hour after ICH symptom onset

• Dynamic changes of serum IL-x levels(ng/ml) within 14 days of symptom onset

  within 14 days of symptom onset

• Dynamic changes of serum NF-kB levels(ug/ml) within 14 days of symptom onset

  within 14 days of symptom onset

Study Arms (2)

sodium aescinate group

EXPERIMENTAL

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

Drug: Sodium Aescinate

placebo group

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Sodium Aescinate DRUG

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

Also known as: Sodium Aescinate for Injection

sodium aescinate group

Placebo DRUG

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

Also known as: 0.9% sodium chloride injection

placebo group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

MeSH Terms

Conditions

Brain Edema; Edema; Cerebral Hemorrhage

Interventions

sodium aescinate; Injections; Sodium Chloride

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Intracranial Hemorrhages; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Ji

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hao Feng

CONTACT

13811059362; fenghao57865578@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2022
• First Posted: March 2, 2022
• Study Start: March 15, 2022
• Primary Completion: December 31, 2024
• Study Completion: March 31, 2025
• Last Updated: March 21, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share