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NCT Number: NCT05891509

DTI-guided Minimally Invasive Hematoma Evacuation for Intracerebral Hemorrhage

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.

Recruiting

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xingguo County People's Hospital

Ganzhou, Jiangxi, China

Location status: Recruiting

Location contact

Guangui Yang, MS

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Minimally invasive hematoma evacuation

Procedure

Procedure of minimally invasive hematoma evacuation PLUS best medical therapy

best medical therapy

Other

Best medical therapy

Primary outcomes

  1. Proportion of score of 0-3 on the modified Rankin scale

    Time frame: 180 days after randomization

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

Secondary outcomes

  1. Score of on the modified Rankin scale

    Time frame: 180 days after randomization

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

Other outcomes

  1. Incidence of symptomatic intracranial hemorrhage

    Time frame: 30 days after randomization

    Symptomatic intracranial hemorrhage will be defined according the Heidelberg bleeding classification criteria

Study contacts

Contact information is provided by the study sponsor or research team.

Zhongming Qiu

CONTACT

[email protected]

+8613236599269

Sponsors and collaborators

Lead sponsor

Zhongming Qiu

Other

Collaborators

  • Xingguo County People's Hospital

Registry information

Official study title

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

Acronym: GLAMOR

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jun 7, 2023
Registry last updated
Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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