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DTI-guided Minimally Invasive Hematoma Evacuation for Intracerebral Hemorrhage (GLAMOR)

Primary Purpose

Stroke Hemorrhagic

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Minimally Invasive Hematoma Evacuation
Best Medical Therapy
Sponsored by
Zhongming Qiu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke Hemorrhagic focused on measuring Minimally Invasive Hematoma Evacuation, Intracerebral Hemorrhage, Randomized Controlled Trial, Magnetic Resonance Imaging

Eligibility Criteria

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

Inclusion Criteria: Age 18-80 years old; Intracerebral hemorrhage in the basal ganglia was diagnosed by CT examination; The amount of bleeding is 20-40ml, and the midline structure is displaced horizontally by < 3mm in the pineal gland; The degree of integrity and continuity of the corticospinal tract on the lesion side of magnetic resonance diffusion tensor imaging was graded as grade 2~4; The time from onset to randomization is within 24 hours; GCS score ≥ 4 points at randomization; Muscle strength level 3 in the affected limb; Written informed consent are provided by the patients or their legal representatives. Exclusion Criteria: Bleeding in other parts (e.g., bleeding in subtentorial areas such as thalamus, brainstem or cerebellum); Bleeding caused by other causes (such as aneurysm, arteriovenous malformation, brain trauma, brain tumor, bleeding transformation of large cerebral infarction, bleeding caused by β amyloidosis, bleeding caused by coagulation dysfunction) or combined with aneurysm, arteriovenous malformation, brain trauma, brain tumor, large-scale cerebral infarction, β amyloidosis, severe coagulation dysfunction; Multiple intracranial hemorrhage; Patients with ventricular hemorrhage or ICH rupture into the ventricles should consider the need for ventricular drainage; Any history of brain parenchymal or other intracranial subarachnoid, subdural or epidural hemorrhage and surgical history in the past 30 days; Myocardial infarction within the past 30 days; Previous history of bleeding, such as gastrointestinal bleeding, genitourinary bleeding, respiratory bleeding that has not been completely controlled; Hemoglobin < 100g/L, hematocrit <25%, platelet count < 100*109/L; Receiving anticoagulant drugs such as warfarin, dabigatran or rivaroxaban within 1 week prior to enrollment, with an INR > 1.4; Long-term anticoagulation and antiplatelet therapy are expected to be required; Allergy to alpeplase, urokinase or surgery-related drugs and instruments; Pregnant or lactating women; Known high risk of embolism, including patients with mechanical heart valves implanted in the body, history of left heart thrombosis, mitral stenosis with atrial fibrillation, acute pericarditis, or subacute bacterial endocarditis. Atrial fibrillation without mitral stenosis is appropriate; hypertension (systolic blood pressure is still greater than 180mmHg) that cannot be effectively controlled by aggressive antihypertensive therapy before randomization; Life expectancy < 12 months in the advanced stage of any disease; Participating in other interventional clinical studies.

Sites / Locations

  • Xingguo County People's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Minimally Invasive Hematoma Evacuation

Best Medical Therapy

Arm Description

Subjects randomized to this arm will receive the intervention of minimally invasive hematoma evacuation and best medical therapy

Subjects randomized to this arm will receive best medical therapy alone

Outcomes

Primary Outcome Measures

Proportion of score of 0-3 on the modified Rankin scale
Scores on the modified Rankin scale range from 0 to 6, with higher scores indicating greater disability.

Secondary Outcome Measures

Score of on the modified Rankin scale
Scores on the modified Rankin scale range from 0 to 6, with higher scores indicating greater disability.

Full Information

First Posted
May 28, 2023
Last Updated
September 8, 2023
Sponsor
Zhongming Qiu
Collaborators
Xingguo County People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05891509
Brief Title
DTI-guided Minimally Invasive Hematoma Evacuation for Intracerebral Hemorrhage
Acronym
GLAMOR
Official Title
Efficacy and Safety of DTI-guided Minimally Invasive Hematoma Evacuation Versus Best Medical Therapy for Acute Spontaneous Intracerebral Hemorrhage: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 3, 2023 (Actual)
Primary Completion Date
May 31, 2027 (Anticipated)
Study Completion Date
August 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zhongming Qiu
Collaborators
Xingguo County People's 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
Intracerebral hemorrhage (ICH) is a devastating disease with high early mortality, unfavorable neurological outcomes, and high cost of care. To date, the role of DTI-guided minimally invasive hematoma evacuation in ICH is still uncertain. The investigators will conduct a multicenter randomized controlled trial, as well as a concurrent prospective observational study including all ICH patients who decline participation in the trial and will therefore receive minimally invasive hematoma evacuation or best medical therapy and consent to be followed up. All participants will be followed up at the same time using the same outcomes measures. The primary outcome will be collected by a blinded assessor.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke Hemorrhagic
Keywords
Minimally Invasive Hematoma Evacuation, Intracerebral Hemorrhage, Randomized Controlled Trial, Magnetic Resonance Imaging

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Other design features: The investigators will conduct a multicenter randomized controlled trial, as well as a concurrent prospective observational study including all ICH patients who decline participation in the trial and will therefore receive minimally invasive hematoma evacuation or best medical therapy and consent to be followed up. All participants will be followed up at the same time using the same outcomes measures. The primary outcome will be collected by a blinded assessor.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Minimally Invasive Hematoma Evacuation
Arm Type
Experimental
Arm Description
Subjects randomized to this arm will receive the intervention of minimally invasive hematoma evacuation and best medical therapy
Arm Title
Best Medical Therapy
Arm Type
Active Comparator
Arm Description
Subjects randomized to this arm will receive best medical therapy alone
Intervention Type
Procedure
Intervention Name(s)
Minimally Invasive Hematoma Evacuation
Intervention Description
Procedure of minimally invasive hematoma evacuation PLUS best medical therapy
Intervention Type
Other
Intervention Name(s)
Best Medical Therapy
Intervention Description
Best medical therapy
Primary Outcome Measure Information:
Title
Proportion of score of 0-3 on the modified Rankin scale
Description
Scores on the modified Rankin scale range from 0 to 6, with higher scores indicating greater disability.
Time Frame
180 days after randomization
Secondary Outcome Measure Information:
Title
Score of on the modified Rankin scale
Description
Scores on the modified Rankin scale range from 0 to 6, with higher scores indicating greater disability.
Time Frame
180 days after randomization
Other Pre-specified Outcome Measures:
Title
Incidence of symptomatic intracranial hemorrhage
Description
Symptomatic intracranial hemorrhage will be defined according the Heidelberg bleeding classification criteria
Time Frame
30 days after randomization

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: Age 18-80 years old; Intracerebral hemorrhage in the basal ganglia was diagnosed by CT examination; The amount of bleeding is 20-40ml, and the midline structure is displaced horizontally by < 3mm in the pineal gland; The degree of integrity and continuity of the corticospinal tract on the lesion side of magnetic resonance diffusion tensor imaging was graded as grade 2~4; The time from onset to randomization is within 24 hours; GCS score ≥ 4 points at randomization; Muscle strength level 3 in the affected limb; Written informed consent are provided by the patients or their legal representatives. Exclusion Criteria: Bleeding in other parts (e.g., bleeding in subtentorial areas such as thalamus, brainstem or cerebellum); Bleeding caused by other causes (such as aneurysm, arteriovenous malformation, brain trauma, brain tumor, bleeding transformation of large cerebral infarction, bleeding caused by β amyloidosis, bleeding caused by coagulation dysfunction) or combined with aneurysm, arteriovenous malformation, brain trauma, brain tumor, large-scale cerebral infarction, β amyloidosis, severe coagulation dysfunction; Multiple intracranial hemorrhage; Patients with ventricular hemorrhage or ICH rupture into the ventricles should consider the need for ventricular drainage; Any history of brain parenchymal or other intracranial subarachnoid, subdural or epidural hemorrhage and surgical history in the past 30 days; Myocardial infarction within the past 30 days; Previous history of bleeding, such as gastrointestinal bleeding, genitourinary bleeding, respiratory bleeding that has not been completely controlled; Hemoglobin < 100g/L, hematocrit <25%, platelet count < 100*109/L; Receiving anticoagulant drugs such as warfarin, dabigatran or rivaroxaban within 1 week prior to enrollment, with an INR > 1.4; Long-term anticoagulation and antiplatelet therapy are expected to be required; Allergy to alpeplase, urokinase or surgery-related drugs and instruments; Pregnant or lactating women; Known high risk of embolism, including patients with mechanical heart valves implanted in the body, history of left heart thrombosis, mitral stenosis with atrial fibrillation, acute pericarditis, or subacute bacterial endocarditis. Atrial fibrillation without mitral stenosis is appropriate; hypertension (systolic blood pressure is still greater than 180mmHg) that cannot be effectively controlled by aggressive antihypertensive therapy before randomization; Life expectancy < 12 months in the advanced stage of any disease; Participating in other interventional clinical studies.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhongming Qiu
Phone
+8613236599269
Email
qiuzhongmingdoctor@163.com
Facility Information:
Facility Name
Xingguo County People's Hospital
City
Ganzhou
State/Province
Jiangxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guangui Yang, MS

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

DTI-guided Minimally Invasive Hematoma Evacuation for Intracerebral Hemorrhage

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