DTI-guided Minimally Invasive Hematoma Evacuation for Intracerebral Hemorrhage

NCT05891509 | Recruiting DMC

• 1 other identifier: GLAMOR
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke Hemorrhagic

Keywords

Minimally Invasive Hematoma Evacuation; Intracerebral Hemorrhage; Randomized Controlled Trial; Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Score of on the modified Rankin scale

  180 days after randomization

Other Outcomes (1)

• Incidence of symptomatic intracranial hemorrhage

  30 days after randomization

Study Arms (2)

Minimally Invasive Hematoma Evacuation

EXPERIMENTAL

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

Procedure: Minimally Invasive Hematoma Evacuation; Other: Best Medical Therapy

Best Medical Therapy

ACTIVE COMPARATOR

Subjects randomized to this arm will receive best medical therapy alone

Other: Best Medical Therapy

Interventions

Minimally Invasive Hematoma Evacuation PROCEDURE

Procedure of minimally invasive hematoma evacuation PLUS best medical therapy

Minimally Invasive Hematoma Evacuation

Best Medical Therapy OTHER

Best medical therapy

Best Medical Therapy; Minimally Invasive Hematoma Evacuation

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Zhongming Qiu: lead
• Xingguo County People's Hospital: collaborator

Study Sites (1)

Xingguo County People's Hospital

Ganzhou, Jiangxi, China

RECRUITING

MeSH Terms

Conditions

Hemorrhagic Stroke; Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Zhongming Qiu

CONTACT

+8613236599269; qiuzhongmingdoctor@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 28, 2023
• First Posted: June 7, 2023
• Study Start: August 3, 2023
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE

Locations

CN (1)