Stroke HemorrhagicGLAMORNCT05891509
DTI-guided Minimally Invasive Hematoma Evacuation for Intracerebral Hemorrhage
A study testing Minimally Invasive Hematoma Evacuation and Best Medical Therapy in people with Stroke Hemorrhagic, run by Zhongming Qiu at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke Hemorrhagic
- What is being tested?
- Minimally Invasive Hematoma Evacuation and Best Medical Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 3 Aug 2023to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xingguo County People's Hospital
Ganzhou, Jiangxi
Guangui Yang, MS
About this study
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
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
- Being tested
- Minimally Invasive Hematoma Evacuation, Best Medical Therapy
- Keywords
- Minimally Invasive Hematoma Evacuation, Intracerebral Hemorrhage, Randomized Controlled Trial, Magnetic Resonance Imaging
- Medical subject headings
- Hemorrhagic Stroke, Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally Invasive Hematoma EvacuationProcedure or surgery
Procedure of minimally invasive hematoma evacuation PLUS best medical therapy
Best Medical TherapyOther
Best medical therapy
| Study group | Role | What they receive |
|---|---|---|
| Minimally Invasive Hematoma Evacuation | Experimental | Subjects randomized to this arm will receive the intervention of minimally invasive hematoma evacuation and best medical therapy Receives: 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 Receives: Other: Best Medical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 180 days after randomization
Secondary outcomes (1)
Score of on the modified Rankin scale
Scores on the modified Rankin scale range from 0 to 6, with higher scores indicating greater disability.
Measured: 180 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start3 Aug 2023
- Primary completion31 May 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke HemorrhagicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongming Qiu
- Sponsor type
- University, hospital or other
- Collaborators
- Xingguo County People's Hospital
- Responsible party
- Sponsor-investigator, Zhongming Qiu, Xinqiao Hospital of Chongqing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05891509
- Sponsor's protocol ID
- GLAMOR
- Acronym
- GLAMOR
- Status last verified
- Sep 2023
- First submitted
- 28 May 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05891509
- Acronym / sponsor ID
- GLAMOR / GLAMOR
- Conditions
- Stroke Hemorrhagic
- Keywords
- Minimally Invasive Hematoma Evacuation, Intracerebral Hemorrhage, Randomized Controlled Trial, Magnetic Resonance Imaging
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Zhongming QiuUniversity, hospital or other
- Collaborators
- Xingguo County People's Hospital
- Study start
- 3 Aug 2023 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 7 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Minimally Invasive Hematoma Evacuation | Experimental | Procedure: Minimally Invasive Hematoma Evacuation, Other: Best Medical TherapySubjects randomized to this arm will receive the intervention of minimally invasive hematoma evacuation and best medical therapy |
| Best Medical Therapy | Active comparator | Other: Best Medical TherapySubjects randomized to this arm will receive best medical therapy alone |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minimally Invasive Hematoma EvacuationProcedure of minimally invasive hematoma evacuation PLUS best medical therapy | Procedure or surgery | Minimally Invasive Hematoma Evacuation |
| Best Medical TherapyBest medical therapy | Other | Best Medical Therapy, Minimally Invasive Hematoma Evacuation |
Primary outcome
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.
1 secondary outcome
Score of on the modified Rankin scale
Time frame: 180 days after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimally Invasive Hematoma Evacuation and Best Medical Therapy in people with Stroke Hemorrhagic, run by Zhongming Qiu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhongming Qiu (+8613236599269, qiuzhongmingdoctor@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of score of 0-3 on the modified Rankin scale (time frame: 180 days after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.