NCT04957849

Brief Summary

The Neuroendoscopic, Trans-occipital Approach Evacuation of Acute Hypertensive Cerebral Hemmorrhage Combined Low-drainage Surgery: a Multi-center Clinical Trial

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

July 3, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 12, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

July 12, 2021

Status Verified

July 1, 2021

Enrollment Period

3 years

First QC Date

July 3, 2021

Last Update Submit

July 3, 2021

Conditions

Hypertensive Intracerebral Hemorrhage

Keywords

neuroendoscopetrans-occipital approachAcute Hypertensive Cerebral HemmorrhageLow-drainage Surgery

Outcome Measures

Primary Outcomes (1)

  • Clinical remission rate

    The evaluation criteria of complete remission: more than 85% of intracranial hematoma was cleared, mild brain edema, and the postoperative hospital stay was less than 2 weeks. The evaluation criteria of partial remission: the clearance rate of intracranial hematoma was 60% - 85%, the postoperative brain edema was obvious, and the postoperative hospital stay was less than 4 weeks.

    1 month postoperation

Study Arms (2)

Trans-frontal keyhole approach

ACTIVE COMPARATOR

After general anesthesia, the patient was placed in supine position with head frame fixed. A straight or arc incision was made in the hairline of the affected side. The incision was 3cm beside the midline. The length of the incision was about 4cm and the diameter of the bone window was about 2.5cm. According to the preoperative thin-layer CT scan, the dura mater and part of the cerebral cortex were cut, and the endoport and other hard channels were inserted. The incision reached 2 / 3 of the length of the hematoma along the direction parallel to the long axis of the hematoma, During the operation, mini aneurysms were clipped to close the responsible vessels, and hemostatic gauze was applied on the surface of the hematoma cavity. Silica gel external drainage tube was placed in the hematoma cavity. The external drainage tube led out the skin through the subcutaneous tunnel, and the dura was sutured.

Procedure: Endoscopic Evacuation of Acute Hypertensive Intracerebral Hemorrhage via Trans-frontal keyhole approach

Trans-occipital keyhole approach

ACTIVE COMPARATOR

After general anesthesia, the patient was placed in prone position with head frame fixed. According to the preoperative thin-layer CT scan, the long axis of hematoma was perpendicular to the ground, and the occipital puncture point was found along the extension line of the long axis of hematoma. Taking the puncture point as the center, a straight or arc incision parallel to the sagittal sinus was taken. The length of the incision was about 4cm, and the diameter of the bone window was about 2.5cm, Endoport and other hard channels were inserted to reach 2 / 3 of the long diameter of the hematoma along the direction parallel to the long axis of the hematoma. Under the neuroendoscope, the hematoma was aspirated or resected in blocks. During the operation, mini aneurysm clamp was used to clamp the responsible vessels, and hemostatic gauze was applied on the surface of the hematoma cavity. Silica gel external drainage tube was placed in the hematoma cavity.

Procedure: The Neuroendoscopic, Trans-occipital Approach Evacuation of Acute Hypertensive Cerebral Hemmorrhage Combined Low-drainage Surgery

Interventions

The Neuroendoscopic, Trans-occipital Approach Evacuation of Acute Hypertensive Cerebral Hemmorrhage Combined Low-drainage SurgeryPROCEDURE

The Neuroendoscopic, Trans-occipital Approach Evacuation of Acute Hypertensive Cerebral Hemmorrhage Combined Low-drainage Surgery

Trans-occipital keyhole approach
Endoscopic Evacuation of Acute Hypertensive Intracerebral Hemorrhage via Trans-frontal keyhole approachPROCEDURE

Endoscopic Evacuation of Acute Hypertensive Intracerebral Hemorrhage via Trans-frontal keyhole approach

Trans-frontal keyhole approach

Eligibility Criteria

Age15 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed patients with spontaneous cerebral hemorrhage in the basal ganglia (in line with the diagnostic criteria of the American Adult Spontaneous Cerebral Hemorrhage Treatment Guidelines (2015)).
  • Head CT showed; hematoma volume ≥ 30ml, intraventricular hemorrhage is not counted as hemorrhage volume.
  • Time from onset to hospital admission ≤8h.
  • The age of the patient is 15-75 years old.
  • Glasgow Coma Score (GCS)\> 5 points.
  • The patient/family knows and signs the informed consent form.
  • Have a clear history of hypertension in the past.

You may not qualify if:

  • Bleeding caused by aneurysm, vascular malformation or tumor stroke.
  • Combined with a history of head injury or trauma.
  • There is more blood in the skull.
  • Past mental disorders or neurological dysfunction.
  • A history of procoagulant dysfunction or anticoagulant drugs.
  • Patients with complications such as liver and kidney dysfunction.
  • Those with poor compliance.
  • Pregnant patients.
  • With massive hemorrhage of the ventricle (the area of the hematoma in the CT side is larger than 1/2 of the transverse section), hemorrhage in the third and fourth ventricles with enlarged ventricles.
  • With late-stage cerebral herniation (bilateral dilated pupils, central respiratory and circulatory failure).
  • Severe cardiovascular and cerebrovascular diseases: such as myocardial infarction, cerebral infarction, coronary heart disease, myocarditis, malignant arrhythmia, etc.
  • Participate in other clinical research 3 months before enrollment.
  • The doctor in charge believes that the study plan cannot be followed.
  • Those who are or plan to become pregnant or breastfeeding.
  • Those who are known to be allergic to test drugs or related products.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurosurgery, Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, 200003, China

Location

MeSH Terms

Conditions

Intracranial Hemorrhage, Hypertensive

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Lijun Hou, MD,PhD

    Shanghai Changzheng Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lijun Hou, MD,PhD

CONTACT

86 21 81885671houlijunsmmu@163.com

Liang Zhao, MD,PhD

CONTACT

86 21 8188568615921509289@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 3, 2021

First Posted

July 12, 2021

Study Start

January 1, 2022

Primary Completion

December 31, 2024

Study Completion

June 30, 2025

Last Updated

July 12, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)