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

NCT04991233 | Unknown DMC

• 1 other identifier: TDSJWK-SCH-EESC-RCT
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

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.

Conditions

Posterior Fossa Hemorrhage

Keywords

Posterior Fossa Hemorrhage; Endoscopic Surgery; Suboccipital Craniotomy; Treatment Outcome

Outcome Measures

Primary Outcomes (1)

• Mortality Rate

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

  Within 30 days after SCH

Secondary Outcomes (4)

• mRS Score

  Within 6 months after SCH

• Adverse Events

  Within 30 days after SCH

• Residual Hematoma Volume

  Within 7 days after SCH

• Perihematoma Edema Volume

  Within 7 days after SCH

Study Arms (2)

Endoscopic surgery

EXPERIMENTAL

Endoscopic surgery group

Procedure: Endoscopic surgery

Suboccipital craniotomy surgery

ACTIVE COMPARATOR

Suboccipital craniotomy surgery group

Procedure: Suboccipital craniotomy surgery

Interventions

Endoscopic surgery PROCEDURE

The endoscopic surgery will be conducted to evacuate the hemorrhage within 24 hours after SCH.

Endoscopic surgery

Suboccipital craniotomy surgery PROCEDURE

The suboccipital craniotomy surgery will be conducted to evacuate the hemorrhage within 24 hours after SCH.

Suboccipital craniotomy surgery

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Tang-Du Hospital: lead

Study Sites (1)

Tandu Hospital, Fourth Military Medical University

Xi'an, Shaanxi, 710038, China

RECRUITING

Related Publications (23)

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MeSH Terms

Conditions

Intracranial Hemorrhages

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Yan Qu, M.D Ph.D

  Tang-Du Hospital

  STUDY CHAIR

• Wei Guo, M.D Ph.D

  Tang-Du Hospital

  STUDY DIRECTOR

Central Study Contacts

Wei Guo, M.D Ph.D

CONTACT

86-18729985168; 18729985168@163.com

Haixiao Liu, M.D Ph.D

CONTACT

86-15929315407; 56761311@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The grouping was blind to the investigators performing the follow-up and the statistical analysis
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2021
• First Posted: August 5, 2021
• Study Start: March 1, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: August 5, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)