NCT07300501

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
33mo left

Started Jan 2026

Typical duration for not_applicable

Geographic Reach
1 country

11 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress12%
Jan 2026Dec 2028

First Submitted

Initial submission to the registry

December 10, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 23, 2025

Completed
9 days until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

December 30, 2025

Status Verified

August 1, 2025

Enrollment Period

3 years

First QC Date

December 10, 2025

Last Update Submit

December 23, 2025

Conditions

Brain Stem Hematoma

Keywords

brain stem hematomaStereotactic aspirationrandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • The Modified Rankin Scale (MRS) score 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.

    at 3 months post-enrollment

Secondary Outcomes (2)

  • Incidence of complications

    assessed at enrollment and again on the third day after enrollment

  • Hospitalization-related Metrics

    at 1 month and 3 months post-enrollment

Study Arms (2)

Conservative Treatment Group

NO INTERVENTION

The Conservative Treatment Group will adhere to the guideline-recommended standard management protocol for intracerebral hemorrhage.

Stereotactic Aspiration Group

EXPERIMENTAL

In addition to receiving the guideline-recommended management for intracerebral hemorrhage, patients in the Stereotactic Aspiration Group will undergo stereotactic aspiration surgery as a routine intervention.

Procedure: stereotactic aspiration surgery

Interventions

stereotactic aspiration surgeryPROCEDURE

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

Stereotactic Aspiration Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary PBSH confirmed by CT/MRI, with hematoma volume \>5 ml;
  • Time from onset to hospital admission and diagnosis within 24 hours;
  • Glasgow Coma Scale (GCS) score of 4-8 (moderate to severe coma);
  • National Institutes of Health Stroke Scale (NIHSS) score ≥21 (severe neurological deficit);
  • Age between 18 and 65 years;
  • Presence of spontaneous respiration upon admission.

You may not qualify if:

  • Hemorrhage caused by vascular malformation, cavernoma, or tumor stroke;
  • presence of severe comorbidities such as significant cardiac, hepatic, or renal insufficiency, or malignant tumors;
  • recent history of antiplatelet or anticoagulant medication use;
  • any condition expected to prevent completion of the 3-month follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

The First Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310000, China

Location

Xiangya Hospital of Central South University

Changsha, China

Location

Zhujiang Hospital,Southern Medical University

Guangzhou, China

Location

Qilu Hospital of Shandong University

Jinan, China

Location

Renji Hospital,School of Medicine,Shanghai Jiaotong University

Shanghai, China

Location

Nanfang Hospital, Southern Medical University

Shenzhen, China

Location

Shenzhen Second People's Hospital

Shenzhen, China

Location

Taizhou First People's Hospital

Taizhou, China

Location

The Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, China

Location

Xijing hospital

Xi'an, China

Location

Henan Provincial People's Hospital

Zhengzhou, China

Location

Related Publications (6)

  • Wang SS, Yang Y, Velz J, Keller E, Luft AR, Regli L, Neidert MC, Bozinov O. Management of brainstem haemorrhages. Swiss Med Wkly. 2019 Apr 5;149:w20062. doi: 10.4414/smw.2019.20062. eCollection 2019 Mar 25.

    PMID: 30950504RESULT

  • Cavalcanti DD, Preul MC, Kalani MY, Spetzler RF. Microsurgical anatomy of safe entry zones to the brainstem. J Neurosurg. 2016 May;124(5):1359-76. doi: 10.3171/2015.4.JNS141945. Epub 2015 Oct 9.

    PMID: 26452114RESULT

  • Sun X, Zhu J, Lu M, Zhang Z, Li C, Zhan R. Robot-assisted puncture versus conservative treatment for severe brainstem hemorrhage: clinical outcomes comparison with experience of 138 cases in a single medical center. World J Emerg Surg. 2025 Feb 25;20(1):15. doi: 10.1186/s13017-025-00592-9.

    PMID: 40001232RESULT

  • Chen LH, Li FJ, Zhang HT, Chen WJ, Sun K, Xu RX. The microsurgical treatment for primary hypertensive brainstem hemorrhage: Experience with 52 patients. Asian J Surg. 2021 Jan;44(1):123-130. doi: 10.1016/j.asjsur.2020.04.016. Epub 2020 Jun 26.

    PMID: 32600922RESULT

  • Chen D, Tang Y, Nie H, Zhang P, Wang W, Dong Q, Wu G, Xue M, Tang Y, Liu W, Pan C, Tang Z. Primary Brainstem Hemorrhage: A Review of Prognostic Factors and Surgical Management. Front Neurol. 2021 Sep 10;12:727962. doi: 10.3389/fneur.2021.727962. eCollection 2021.

    PMID: 34566872RESULT

  • Li Y, Shang FJ, Xu Z, Wu DX, Li CH, Liu JF, Li YX, Zhang WH, Zhang WC. Comparison of stereotactic aspiration surgery and conventional treatment for primary brainstem haemorrhage. Clin Neurol Neurosurg. 2023 Nov;234:108008. doi: 10.1016/j.clineuro.2023.108008. Epub 2023 Oct 3.

    PMID: 37866210RESULT

Study Officials

  • Xiaofeng YANG, Doctor of Medicine

    Zhejiang University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaofeng YANG, Doctor of Medicine

CONTACT

+86-13606504517zjcswk@zju.edu.cn

Yadong WANG, Doctor of Medicine

CONTACT

+86-1836888517611718340@zju.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2025

First Posted

December 23, 2025

Study Start

January 1, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

December 30, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

We plan to share anonymized Individual Participant Data (IPD) to promote scientific collaboration and transparency. The data sharing plan is as follows: 1. What data will be shared? De-identified IPD underlying the results reported in the primary and secondary publications of this trial; The study protocol, statistical analysis plan , and informed consent form; The analytical code used to generate the results. 2. When and how will data be available? Data will become accessible 12 months after the publication of the primary results of the trial. Requests can be submitted via email to the corresponding author or through a designated data repository platform. 3. Additional protections: All shared data will be fully anonymized in accordance with applicable laws (China's Personal Information Protection Law) and international standards to protect participant privacy. Direct identifiers and any information with re-identification risk will be removed.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Data will become accessible 12 months after the publication of the primary results of the trial

Locations

CN(11)