GLAMOR: DTI-guided Minimally Invasive Hematoma Evacuation for Intracerebral Hemorrhage

Sponsor

Zhongming Qiu (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05891509

Collaborator

Xingguo County People's Hospital (Other)

100

Enrollment

Location

Arms

51.1

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke Hemorrhagic	Procedure: Minimally Invasive Hematoma Evacuation Other: Best Medical Therapy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

May 28, 2023

Anticipated Primary Completion Date :

May 31, 2027

Anticipated Study Completion Date :

Aug 31, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Minimally Invasive Hematoma Evacuation Subjects randomized to this arm will receive the intervention of minimally invasive hematoma evacuation and best medical therapy	Procedure: Minimally Invasive Hematoma Evacuation Procedure of minimally invasive hematoma evacuation PLUS best medical therapy Other: Best Medical Therapy Best medical therapy
Active Comparator: Best Medical Therapy Subjects randomized to this arm will receive best medical therapy alone	Other: Best Medical Therapy Best medical therapy

Arm

Intervention/Treatment

Experimental: Minimally Invasive Hematoma Evacuation

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

Procedure: Minimally Invasive Hematoma Evacuation

Procedure of minimally invasive hematoma evacuation PLUS best medical therapy

Other: Best Medical Therapy

Best medical therapy

Active Comparator: Best Medical Therapy

Subjects randomized to this arm will receive best medical therapy alone

Other: Best Medical Therapy

Best medical therapy

Outcome Measures

Primary Outcome Measures

Proportion of score of 0-3 on the modified Rankin scale [180 days after randomization]
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 [180 days after randomization]
Scores on the modified Rankin scale range from 0 to 6, with higher scores indicating greater disability.

Other Outcome Measures

Incidence of symptomatic intracranial hemorrhage [30 days after randomization]
Symptomatic intracranial hemorrhage will be defined according the Heidelberg bleeding classification criteria

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.