ClinicalTrials.gg
RecruitingNCT05891509GLAMORUpdated Sep 13, 2023

DTI-guided Minimally Invasive Hematoma Evacuation for Intracerebral Hemorrhage

An interventional study of Minimally Invasive Hematoma Evacuation and Best Medical Therapy in Stroke Hemorrhagic, sponsored by Zhongming Qiu. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-09-13.

Sponsored by Zhongming Qiu · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2023; still recruiting 3 years 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 25 studies in Hemorrhagic Stroke with a site in China — 14 open to participants now, 14 under way, none of them phase 3. Hemorrhagic Stroke · China.

Planned enrollment
13th of 14
100 · median 410
Started
2023
with 2 others
No phase
6 of 25
3 open now
Primary completion
2027-05
later than 4 of 13 live
Registered
14th of 25
by date

Among the 25 studies in Hemorrhagic Stroke with a site in China, this one is the 13th largest by planned enrollment of the 14 interventional ones that give a count, is one of 3 that started in 2023, is one of 6 with no phase, reaches primary completion later than 4 of the 13 other live ones, and was the 14th registered.

Hemorrhagic Stroke

233 studies on the registry are indexed under Hemorrhagic Stroke; 93 are open to participants now.

Browse Hemorrhagic Stroke studies →

Open to participants now

14 of the 25 studies in Hemorrhagic Stroke with a site in China are open now. Recruiting first, the newest first:

8 more — sign in →

All 14 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 62 Hemorrhagic Stroke studies recruiting now, 36 (58%) set no upper age limit and 7 (11%) stop at 75 or younger; 5 take children under 18; 7 take healthy volunteers.

This study: 18 Years to 80 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 25 studies in Hemorrhagic Stroke with a site in China, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Stroke Hemorrhagic

Keywords

  • Minimally Invasive Hematoma Evacuation
  • Intracerebral Hemorrhage
  • Randomized Controlled Trial
  • Magnetic Resonance Imaging
04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 are provided by the patients or their legal representatives.

Exclusion criteria

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. \< 100g/L, hematocrit \<25%, count \< 100*109/L;
  9. Receiving anticoagulant drugs such as warfarin, dabigatran or rivaroxaban within 1 week prior to enrollment, with an > 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. \< 12 months in the advanced stage of any disease;
  16. Participating in other interventional clinical studies.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • 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 · Other: Best Medical Therapy

  • Active comparator
    Best Medical Therapy

    Subjects randomized to this arm will receive best medical therapy alone

    Other: Best Medical Therapy

Interventions

  • ProcedureMinimally Invasive Hematoma Evacuation

    Procedure of minimally invasive hematoma evacuation PLUS best medical therapy

  • OtherBest Medical Therapy

    Best medical therapy

06

What researchers measure

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.

    Time frame: 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.

    Time frame: 180 days after randomization

Other outcomes

  1. Incidence of symptomatic intracranial hemorrhage

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

    Time frame: 30 days after randomization

07

Study locations

1 of 1 sites recruiting
  • Xingguo County People's Hospital
    Ganzhou, Jiangxi, China
    Recruiting
    • Guangui Yang, MS · Contact
08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Statistical analysis plan, Clinical study report, Analytic code

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2023 (actual). Primary completion is estimated for May 2027, 45 months after the start.

Of 75 non-industry interventional studies with no phase under Hemorrhagic Stroke, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 57. This study's planned 45 months is above that.

Counting every sponsor, half of 89 studies reached it within 36 months; a quarter within 14 and three quarters within 56.

How these figures are worked out, and which studies are left out of them.

Registered
May 28, 2023
First posted
Jun 7, 2023
StartActual
Aug 3, 2023
Primary completionEst.
May 31, 2027
CompletionEst.
Aug 31, 2027
Last update
Sep 13, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05891509
Lead sponsor
Zhongming Qiu
Collaborators
Xingguo County People's Hospital
Responsible party
Zhongming Qiu (Professor, Xinqiao Hospital of Chongqing) — Sponsor-investigator
First posted
Jun 7, 2023
Start date
Aug 3, 2023
Primary completion
May 31, 2027 (estimated)
Completion
Aug 31, 2027 (estimated)
Last update
Sep 13, 2023

Study contacts

Zhongming Qiu
Contact
qiuzhongmingdoctor@163.com
+8613236599269

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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