NCT05891509

DTI-guided Minimally Invasive Hematoma Evacuation for Intracerebral Hemorrhage

Efficacy and Safety of DTI-guided Minimally Invasive Hematoma Evacuation Versus Best Medical Therapy for Acute Spontaneous Intracerebral Hemorrhage: a Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Zhongming Qiu · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Intracerebral hemorrhage (ICH) is a devastating disease with high early mortality, unfavorable neurological outcomes, and high cost of care. To date, the role of DTI-guided minimally invasive hematoma evacuation in ICH is still uncertain. The investigators will conduct a multicenter randomized controlled trial, as well as a concurrent prospective observational study including all ICH patients who decline participation in the trial and will therefore receive minimally invasive hematoma evacuation or best medical therapy and consent to be followed up. All participants will be followed up at the same time using the same outcomes measures. The primary outcome will be collected by a blinded assessor.

Conditions

• Stroke Hemorrhagic

Interventions

Type	Name	Description
PROCEDURE	Minimally Invasive Hematoma Evacuation	Procedure of minimally invasive hematoma evacuation PLUS best medical therapy
OTHER	Best Medical Therapy	Best medical therapy

Timeline

• Start date: 2023-08-03
• Primary completion: 2027-05-31
• Completion: 2027-08-31
• First posted: 2023-06-07
• Last updated: 2023-09-13

Locations

1 site across 1 country: China