Reduction of Edema With a Specialized Cocktail for Ultra-early Management in Intracerebral Hemorrhage

Launched by SECOND AFFILIATED HOSPITAL, SCHOOL OF MEDICINE, ZHEJIANG UNIVERSITY · Mar 3, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients who have experienced an intracerebral hemorrhage (ICH), which is a type of stroke caused by bleeding in the brain. The trial will test a specialized medication cocktail designed to reduce swelling in the brain, known as edema, which can lead to serious complications. Researchers will compare the effects of this new treatment to standard care in 58 patients who have a certain size of hemorrhage but are not undergoing surgery for it. The main goal is to see if the new treatment can effectively decrease brain swelling within 5 to 7 days, as measured by CT scans, while also evaluating overall recovery and safety.

To be eligible for this trial, participants must be at least 18 years old and have had symptoms of ICH within the last 72 hours, with a confirmed bleeding volume of at least 15 mL. They should not be scheduled for surgery to remove the bleeding. It’s important to note that patients with certain severe health conditions or specific medical histories may not be able to participate. If someone is eligible and chooses to join, they will receive either the new treatment or the standard care and will be monitored closely over the next few months to assess their health and recovery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥18 years
• • Clinical diagnosis of supratentorial intracerebral hemorrhage (ICH)
• • Symptom onset within 3 days (≤72 hours) before randomization
• • Baseline CT-confirmed hematoma volume ≥3 mL
• • Not scheduled for hematoma evacuation surgery (either not indicated or declined by the patient/family)
• • Written informed consent obtained from the patient or legally authorized representative
• Exclusion Criteria:
• • Baseline brain herniation or severe hypotension (SBP \<90 mmHg)
• • Contraindications to PPA medications (terazosin, urapidil, esmolol, propranolol), such as asthma or severe bradycardia
• • Severe comorbidities that may interfere with efficacy assessment or pose a high safety risk (e.g., end-stage organ failure, advanced malignancy)
• • Presence of secondary causes of ICH (e.g., arteriovenous malformation, aneurysm rupture, hemorrhagic transformation of ischemic stroke)
• • Pregnancy or lactation
• • Participation in another interventional trial that may influence study outcomes