Stereotactic Aspiration of Brain Stem Hematoma

Condition(s) studied

Investigational drug(s) / intervention(s)

stereotactic aspiration surgery: Stereotactic aspiration of the brainstem hematoma is performed with the aid of a surgical robot for precise localization.

Study summary

This clinical study is a high-level evidence-based medical research project designed to compare the efficacy differences between stereotactic aspiration and conservative treatment in patients with brainstem hemorrhage. Brainstem hemorrhage is a life-threatening condition with extremely high rates of mortality and disability. Currently, there is ongoing debate regarding its treatment strategies, particularly the necessity of surgical intervention. Although surgical explorations have been conducted in China, there is a lack of high-quality, multi-center randomized controlled trial (RCT) evidence.

To address this, the present study was initiated by the First Affiliated Hospital, Zhejiang University School of Medicine, in collaboration with dozens of leading medical centers across China. The study adopts a prospective, multi-center, single-blind, randomized controlled design. It plans to enroll 300 eligible patients with primary brainstem hemorrhage, who will be randomly assigned to either the stereotactic aspiration treatment group or the conservative treatment group.

Key inclusion criteria are: radiologically confirmed brainstem hematoma volume \>5 ml; hospital admission within 24 hours of onset; Glasgow Coma Scale (GCS) score of 4-8; National Institutes of Health Stroke Scale (NIHSS) score ≥21; age between 18 and 65 years; and presence of spontaneous respiration.

The primary endpoint of the study is the Modified Rankin Scale (MRS) score at 3 months post-treatment, which assesses neurological recovery and the degree of disability. Secondary endpoints include the incidence of complications such as acute hydrocephalus, intracranial infection, pulmonary infection, and re-bleeding, as well as the length of ICU stay and total hospital stay.

The study will strictly implement randomization and blinding procedures. Randomization will be centrally managed by the principal center, and outcome assessors will be blinded to ensure the objectivity and scientific rigor of the data. All participating centers are required to have extensive experience in minimally invasive treatment of brainstem hemorrhage. The study is expected to last for 3 years, encompassing phases for patient recruitment, treatment implementation, data collection, and statistical analysis.

The findings of this study are expected to provide high-level evidence-based medical evidence for the challenging clinical problem of brainstem hemorrhage, clarify the therapeutic value of stereotactic minimally invasive surgery, and thereby guide clinical practice and improve patient outcomes.

Eligibility

Primary outcome measure(s)

• The Modified Rankin Scale (MRS) score at 3 months post-enrollment — at 3 months post-enrollment
  This internationally recognized scale is the core tool for assessing disability after stroke, scored from 0 to 6, with higher scores indicating greater disability or death. This study will analyze the distribution difference of MRS scores between the two groups.

Trial sites (11)

More First Affiliated Hospital of Zhejiang University trials in China