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
Location: See location...
Intervention Type: Procedure, Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Age 18-80 years old;

• Intracerebral hemorrhage in the basal ganglia was diagnosed by CT examination;

• The amount of bleeding is 20-40ml, and the midline structure is displaced horizontally by \< 3mm in the pineal gland;

• The degree of integrity and continuity of the corticospinal tract on the lesion side of magnetic resonance diffusion tensor imaging was graded as grade 2\

⁃ 4;

• The time from onset to randomization is within 24 hours;

• GCS score ≥ 4 points at randomization;

• Muscle strength level 3 in the affected limb;

• Written informed consent are provided by the patients or their legal representatives.

Locations
Other Locations
China
Xingguo County People's Hospital
RECRUITING
Ganzhou
Contact Information
Primary
Zhongming Qiu
qiuzhongmingdoctor@163.com
+8613236599269
Time Frame
Start Date: 2023-08-03
Estimated Completion Date: 2027-08-31
Participants
Target number of participants: 100
Treatments
Experimental: Minimally Invasive Hematoma Evacuation
Subjects randomized to this arm will receive the intervention of minimally invasive hematoma evacuation and best medical therapy
Active_comparator: Best Medical Therapy
Subjects randomized to this arm will receive best medical therapy alone
Related Therapeutic Areas
Sponsors
Collaborators: Xingguo County People's Hospital
Leads: Zhongming Qiu

This content was sourced from clinicaltrials.gov