The Treatment Effect of Endoscopic Evacuation Versus Suboccipital Craniotomy for Spontaneous Intracerebellar Hemorrhage.

August 3, 2021 updated by: Tang-Du Hospital

The Effectiveness and Safety of Endoscopic Evacuation Versus Suboccipital Craniotomy in the Treatment of Spontaneous Intracerebellar Hemorrhage (SCH) -a Randomized Control Trial.

The purpose of the present study is to compare the effectiveness and safety of two surgery evacuation methods (endoscopic surgery and suboccipital craniotomy) in the treatment of acute spontaneous cerebellar hemorrhage (SCH). A multi-center randomized control trial will be conducted. Patients with an initial GCS score of 5-14 will be screened and enrolled in the first 24 hours after SCH.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Spontaneous cerebellar hemorrhage (SCH) accounts for about 9-10% of all ICH cases, with a mortality rate of 20-50%. Suboccipital craniotomy was the traditional surgery method in the treatment of SCH. Minimally invasive techniques, including endoscopic evacuation and minimally invasive catheter (MIC) evacuation, have been used for the treatment of SCH) in recent years. However, credible evidence is still needed to validate the effects of these techniques. The treatment effect of endoscopic evacuation and MIC evacuation was compared in our previous study, results showed that the endoscopic evacuation significantly decreased the 6-month mortality of SCH patients. Thus endoscopic evacuation might be a safer and more effective option in the treatment of SCH. Therefore, in the current study, a multi-center randomized control trial will be conducted to compare the effectiveness and safety of endoscopic surgery and suboccipital craniotomy in the treatment of acute SCH. A multi-center randomized control trial will be conducted. Patients with an initial GCS score of 5-14 will be screened according to the selecting criteria. The enrolled patients will undertake the surgery within the first 24 hours after SCH. The primary outcome is the 30-day mortality rate. And the secondary outcomes including the 6-month mRS, the incidence of adverse events within 30-day, the hematoma clearance rate, the residual hematoma volume on postoperative day 1/3/7, and the perihematoma edema volume on postoperative day 1/3/7.

Study Type

Interventional

Enrollment (Anticipated)

190

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Haixiao Liu, M.D Ph.D
  • Phone Number: 86-15929315407
  • Email: 56761311@qq.com

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710038
        • Recruiting
        • Tandu Hospital, Fourth Military Medical University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yan Qu, M.D, Ph.D
        • Principal Investigator:
          • Wei Guo, M.D, Ph.D
        • Sub-Investigator:
          • Haixiao Liu, M.D, Ph.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Aged 18-80 years old;
  2. Cerebellar hemorrhage was confirmed by computed tomography (CT) scans;
  3. The hematoma was > 3 cm in diameter or the hematoma volume was > 10ml or the hemorrhage is associated with brainstem compression or hydrocephalus;
  4. The randomization can be conducted within 24 hours;
  5. GCS score at randomization was 5-14;
  6. mRS was 0-1 before onset;
  7. The systolic pressure was controlled below 180 mmHg before randomization;
  8. Informed consent was obtained from the patient and his legal representative.

Exclusion Criteria:

  1. Coexistent intracranial bleeding from other sites;
  2. Brain herniation before randomization;
  3. Bleeding caused by other reasons such as aneurysm, arteriovenous malformation, trauma, and tumor; hemorrhage secondary to large cerebral infarction, beta-amyloid degeneration disease, or coagulation dysfunction; coexistent aneurysm, arteriovenous malformation, brain trauma, brain tumors, large area cerebral infarction, beta-amyloid degeneration disease, or serious blood coagulation disorders;
  4. A history of cerebral hemorrhage within 1 year;
  5. A history of intracranial surgery or hemorrhagic disease (intracerebral hemorrhage, subarachnoid hemorrhage, subdural or epidural hemorrhage) within the last 30 days;
  6. Hemoglobin < 100g/L, hematocrit < 25%, platelet count <100*10^9/L;
  7. Warfarin, dabigatran, rivaroxaban, and other anticoagulant drugs were given within one week before enrollment, and the INR was > 1.4;
  8. Aspirin, clopidogrel, ticagrelor, and other antiplatelet drugs were given within one week before enrollment, and the inhibition rate of AA-dependent pathway > 50%，inhibition rate of ADP-dependent pathway > 30%;
  9. Long-term anticoagulation and antiplatelet therapy is needed;
  10. A history of internal bleeding that is not completely controlled, such as gastrointestinal bleeding, genitourinary bleeding, respiratory bleeding;
  11. Myocardial infarction within 30 days;
  12. Patients with high risks of embolization (a history of mechanical heart valve implantation, left ventricular thrombosis, mitral stenosis with atrial fibrillation, acute pericarditis, or subacute bacterial endocarditis); atrial fibrillation without mitral stenosis is acceptable;
  13. Severely impaired liver function (ALT > 3 times the normal upper limit, or AST > 3 times the normal upper limit); severely impaired renal function (glomerular filtration rate < 30ml/min/1.73m2);
  14. Hypertension could not be effectively controlled before randomization (systolic blood pressure ≥ 180 mmHg);
  15. Patients cannot complete the follow-up due to Alzheimer's disease or mental illness;
  16. Coexistent serious diseases of the respiratory, circulatory, digestive, urogenital, endocrine, immune, and blood systems that are likely to interfere with the results;
  17. Patients with current drug/alcohol abuse or dependence, or expected to have poor compliance and difficult to complete the follow-up;
  18. Allergic to the drugs or instruments used in surgery;
  19. Patients with surgery contraindications, or the other factors that may preclude implementation of the study protocol;
  20. Pregnant or lactating women;
  21. Life expectancy < 12 months due to any advanced stage of disease;
  22. Patient is participating in other clinical trials;
  23. The legal guardian of the patient is unwilling to sign the written informed consent;
  24. Assessed unsuitable for inclusion by investigators.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Endoscopic surgery
Endoscopic surgery group
Procedure: Endoscopic surgery
The endoscopic surgery will be conducted to evacuate the hemorrhage within 24 hours after SCH.
Active Comparator: Suboccipital craniotomy surgery
Suboccipital craniotomy surgery group
Procedure: Suboccipital craniotomy surgery
The suboccipital craniotomy surgery will be conducted to evacuate the hemorrhage within 24 hours after SCH.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality Rate
Time Frame: Within 30 days after SCH
The mortality rate in each group at 30 days after SCH.
Within 30 days after SCH

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mRS Score
Time Frame: Within 6 months after SCH
The mortality rate in each group at 6 months after SCH.
Within 6 months after SCH
Adverse Events
Time Frame: Within 30 days after SCH
The Incidence of adverse events within 30 days after SCH.
Within 30 days after SCH
Residual Hematoma Volume
Time Frame: Within 7 days after SCH
The residual hematoma volume on postoperative day 1, day 3 and day 7.
Within 7 days after SCH
Perihematoma Edema Volume
Time Frame: Within 7 days after SCH
The perihematoma edema volume on postoperative day 1, day 3 and day 7.
Within 7 days after SCH

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tang-Du Hospital

Investigators

  • Study Chair: Yan Qu, M.D Ph.D, Tang-Du Hospital
  • Study Director: Wei Guo, M.D Ph.D, Tang-Du Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

April 7, 2021

First Submitted That Met QC Criteria

August 3, 2021

First Posted (Actual)

August 5, 2021

Study Record Updates

Last Update Posted (Actual)

August 5, 2021

Last Update Submitted That Met QC Criteria

August 3, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TDSJWK-SCH-EESC-RCT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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