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

Primary Purpose

Posterior Fossa Hemorrhage

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Endoscopic surgery
Suboccipital craniotomy surgery
Sponsored by
Tang-Du Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posterior Fossa Hemorrhage focused on measuring Posterior Fossa Hemorrhage, Endoscopic Surgery, Suboccipital Craniotomy, Treatment Outcome

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Tandu Hospital, Fourth Military Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Endoscopic surgery

Suboccipital craniotomy surgery

Arm Description

Endoscopic surgery group

Suboccipital craniotomy surgery group

Outcomes

Primary Outcome Measures

Mortality Rate
The mortality rate in each group at 30 days after SCH.

Secondary Outcome Measures

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

Full Information

First Posted
April 7, 2021
Last Updated
August 3, 2021
Sponsor
Tang-Du Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04991233
Brief Title
The Treatment Effect of Endoscopic Evacuation Versus Suboccipital Craniotomy for Spontaneous Intracerebellar Hemorrhage.
Official Title
The Effectiveness and Safety of Endoscopic Evacuation Versus Suboccipital Craniotomy in the Treatment of Spontaneous Intracerebellar Hemorrhage (SCH) -a Randomized Control Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tang-Du Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posterior Fossa Hemorrhage
Keywords
Posterior Fossa Hemorrhage, Endoscopic Surgery, Suboccipital Craniotomy, Treatment Outcome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The grouping was blind to the investigators performing the follow-up and the statistical analysis
Allocation
Randomized
Enrollment
190 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Endoscopic surgery
Arm Type
Experimental
Arm Description
Endoscopic surgery group
Arm Title
Suboccipital craniotomy surgery
Arm Type
Active Comparator
Arm Description
Suboccipital craniotomy surgery group
Intervention Type
Procedure
Intervention Name(s)
Endoscopic surgery
Intervention Description
The endoscopic surgery will be conducted to evacuate the hemorrhage within 24 hours after SCH.
Intervention Type
Procedure
Intervention Name(s)
Suboccipital craniotomy surgery
Intervention Description
The suboccipital craniotomy surgery will be conducted to evacuate the hemorrhage within 24 hours after SCH.
Primary Outcome Measure Information:
Title
Mortality Rate
Description
The mortality rate in each group at 30 days after SCH.
Time Frame
Within 30 days after SCH
Secondary Outcome Measure Information:
Title
mRS Score
Description
The mortality rate in each group at 6 months after SCH.
Time Frame
Within 6 months after SCH
Title
Adverse Events
Description
The Incidence of adverse events within 30 days after SCH.
Time Frame
Within 30 days after SCH
Title
Residual Hematoma Volume
Description
The residual hematoma volume on postoperative day 1, day 3 and day 7.
Time Frame
Within 7 days after SCH
Title
Perihematoma Edema Volume
Description
The perihematoma edema volume on postoperative day 1, day 3 and day 7.
Time Frame
Within 7 days after SCH

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 18-80 years old; Cerebellar hemorrhage was confirmed by computed tomography (CT) scans; The hematoma was > 3 cm in diameter or the hematoma volume was > 10ml or the hemorrhage is associated with brainstem compression or hydrocephalus; The randomization can be conducted within 24 hours; GCS score at randomization was 5-14; mRS was 0-1 before onset; The systolic pressure was controlled below 180 mmHg before randomization; Informed consent was obtained from the patient and his legal representative. Exclusion Criteria: Coexistent intracranial bleeding from other sites; Brain herniation before randomization; 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; A history of cerebral hemorrhage within 1 year; A history of intracranial surgery or hemorrhagic disease (intracerebral hemorrhage, subarachnoid hemorrhage, subdural or epidural hemorrhage) within the last 30 days; Hemoglobin < 100g/L, hematocrit < 25%, platelet count <100*10^9/L; Warfarin, dabigatran, rivaroxaban, and other anticoagulant drugs were given within one week before enrollment, and the INR was > 1.4; 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%; Long-term anticoagulation and antiplatelet therapy is needed; A history of internal bleeding that is not completely controlled, such as gastrointestinal bleeding, genitourinary bleeding, respiratory bleeding; Myocardial infarction within 30 days; 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; 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); Hypertension could not be effectively controlled before randomization (systolic blood pressure ≥ 180 mmHg); Patients cannot complete the follow-up due to Alzheimer's disease or mental illness; Coexistent serious diseases of the respiratory, circulatory, digestive, urogenital, endocrine, immune, and blood systems that are likely to interfere with the results; Patients with current drug/alcohol abuse or dependence, or expected to have poor compliance and difficult to complete the follow-up; Allergic to the drugs or instruments used in surgery; Patients with surgery contraindications, or the other factors that may preclude implementation of the study protocol; Pregnant or lactating women; Life expectancy < 12 months due to any advanced stage of disease; Patient is participating in other clinical trials; The legal guardian of the patient is unwilling to sign the written informed consent; Assessed unsuitable for inclusion by investigators.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Guo, M.D Ph.D
Phone
86-18729985168
Email
18729985168@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Haixiao Liu, M.D Ph.D
Phone
86-15929315407
Email
56761311@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yan Qu, M.D Ph.D
Organizational Affiliation
Tang-Du Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Wei Guo, M.D Ph.D
Organizational Affiliation
Tang-Du Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Tandu Hospital, Fourth Military Medical University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710038
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Guo, M.D Ph.D
Phone
86-18729985168
Email
18729985168@163.com
First Name & Middle Initial & Last Name & Degree
Haixiao Liu, M.D
Phone
86-15929315407
Email
56761311@qq.com
First Name & Middle Initial & Last Name & Degree
Yan Qu, M.D, Ph.D
First Name & Middle Initial & Last Name & Degree
Wei Guo, M.D, Ph.D
First Name & Middle Initial & Last Name & Degree
Haixiao Liu, M.D, Ph.D

12. IPD Sharing Statement

Plan to Share IPD
No
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The Treatment Effect of Endoscopic Evacuation Versus Suboccipital Craniotomy for Spontaneous Intracerebellar Hemorrhage.

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