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

Efficacy and Safety of DTI-guided Minimally Invasive Hematoma Evacuation Versus Best Medical Therapy for Acute Spontaneous Intracerebral Hemorrhage: a Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke Hemorrhagic
• Intervention / Treatment: Procedure: Minimally Invasive Hematoma Evacuation; Other: Best Medical Therapy

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhongming Qiu; Phone Number: +8613236599269; Email: qiuzhongmingdoctor@163.com

Study Locations

• China
  • Jiangxi
    • Ganzhou, Jiangxi, China
      • Recruiting
      • Xingguo County People's Hospital
      • Contact: Guangui Yang, MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 18-80 years old;
2. Intracerebral hemorrhage in the basal ganglia was diagnosed by CT examination;
3. The amount of bleeding is 20-40ml, and the midline structure is displaced horizontally by < 3mm in the pineal gland;
4. 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;
5. The time from onset to randomization is within 24 hours;
6. GCS score ≥ 4 points at randomization;
7. Muscle strength level 3 in the affected limb;
8. Written informed consent are provided by the patients or their legal representatives.

Exclusion Criteria:

1. Bleeding in other parts (e.g., bleeding in subtentorial areas such as thalamus, brainstem or cerebellum);
2. 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;
3. Multiple intracranial hemorrhage;
4. Patients with ventricular hemorrhage or ICH rupture into the ventricles should consider the need for ventricular drainage;
5. Any history of brain parenchymal or other intracranial subarachnoid, subdural or epidural hemorrhage and surgical history in the past 30 days;
6. Myocardial infarction within the past 30 days;
7. Previous history of bleeding, such as gastrointestinal bleeding, genitourinary bleeding, respiratory bleeding that has not been completely controlled;
8. Hemoglobin < 100g/L, hematocrit <25%, platelet count < 100*109/L;
9. Receiving anticoagulant drugs such as warfarin, dabigatran or rivaroxaban within 1 week prior to enrollment, with an INR > 1.4;
10. Long-term anticoagulation and antiplatelet therapy are expected to be required;
11. Allergy to alpeplase, urokinase or surgery-related drugs and instruments;
12. Pregnant or lactating women;
13. 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;
14. hypertension (systolic blood pressure is still greater than 180mmHg) that cannot be effectively controlled by aggressive antihypertensive therapy before randomization;
15. Life expectancy < 12 months in the advanced stage of any disease;
16. Participating in other interventional clinical studies.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	180 days after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Score of on the modified Rankin scale	Scores on the modified Rankin scale range from 0 to 6, with higher scores indicating greater disability.	180 days after randomization

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of symptomatic intracranial hemorrhage	Symptomatic intracranial hemorrhage will be defined according the Heidelberg bleeding classification criteria	30 days after randomization

Collaborators and Investigators

• Sponsor: Zhongming Qiu
• Collaborators: Xingguo County People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2023
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: May 28, 2023
• First Submitted That Met QC Criteria: June 5, 2023
• First Posted (Actual): June 7, 2023

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 8, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Magnetic Resonance Imaging; Intracerebral Hemorrhage; Minimally Invasive Hematoma Evacuation
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Intracranial Hemorrhages; Hemorrhage; Cerebral Hemorrhage; Hemorrhagic Stroke; Hematoma
• Other Study ID Numbers: GLAMOR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No