An interventional study of Onyx and Burr-hole in Subdural Hematoma, Non-acute, sponsored by Huashan Hospital. Active, not recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-30.
Sponsored by Huashan Hospital · Not applicable, Interventional, and Treatment
MAGIC-MT study is multi-center, prospective, randomized (1:1) controlled trial designed to show that additional MMA embolization with Onyx in patients with non-acute symptomatic subdural hematoma(SDH) results in reduced hematoma recurrence in surgically treated patients/ reduced hematoma progression in conservatively managed patients.
The objective of this study is to show that additional MMA embolization with Onyx in patients with non-acute symptomatic subdural hematoma(SDH) results in reduced hematoma recurrence in surgically treated patients/ reduced hematoma progression in conservatively managed patients.
44 studies on the registry are indexed under Hematoma, Subdural; 15 are open to participants now.
This study's planned enrollment of 722 is above the median of 105 across 30 interventional studies indexed under Hematoma, Subdural.
Browse Hematoma, Subdural studies →Huashan Hospital is the lead sponsor of 247 studies on the registry; 104 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Patients with symptomatic non-acute SDH with mass effect (i.e., chronic or subacute SDH)
Exclusion Criteria:
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.
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.
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.
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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Middle meningeal artery(MMA) embolization
Device: Onyx · Procedure: Burr-hole · Other: Medical Management
Traditional treatment group
Procedure: Burr-hole · Other: Medical Management
Embolization of the Middle Meningeal Artery using the liquid embolic material
Burr-hole drainage of subdural hematoma
best medical management
Incidence of symptomatic SDH recurrence/ progression within 90 days post-procedure
SDH recurrence (\>10 mm max. thickness) or receiving re-operation in patients who underwent surgery/ symptomatic SDH progression (\>3 mm increase in max thickness or receiving surgical rescue in patients who did not undergo sugery) at 90 days "Symptomatic" is hereby defined as one or more of the following features which are attributed to the progression/recurrence: headache, short-term cognitive decline, speech difficulty or aphasia, gait impairment, focal weakness, sensory deficits, seizures
Time frame: 90 days
Effectiveness
Incidence of SDH recurrence/ progression at 1 year post-procedure
Time frame: 1 year post-procedure
Effectiveness
Rate of successful embolization of the target vessels (MMA trunk and branches) with ONYX base on DSA imaging
Time frame: day 0
Effectiveness
Change in hematoma thickness based on CT/MRI imaging at 90 days post-procedure
Time frame: 90 days post-procedure
Effectiveness
Changes in hematoma volume at 90 days post-procedure
Time frame: 90 days post-procedure
Effectiveness
Change in Midline shift based on CT/MRI imaging at 90 days post-procedure
Time frame: 90 days post-procedure
Effectiveness
Change in the Modified Rankin Scale score (mRS) Grade 0 (no symptoms) to 6 (death) at 90 days and 1 year post-procedure
Time frame: 90 days and 1 year post-procedure
Effectiveness
Percentage of patients with favorable functional outcome defined as Modified Rankin Scale of 0 to 3 at 90 days and 1year post-procedure
Time frame: 90 days and 1 year post-procedure
Effectiveness
Percentage of patients with good functional outcome defined as Modified Rankin Scale of 0 to 2 at 90 days and 1 year post-procedure
Time frame: 90 days and 1 year post-procedure
Effectiveness
Quality of life assessed by (EuroQol) EQ-5D scale Grade 0 (worst health) to 100 (best health) at 90 days and 1 year post-procedure
Time frame: 90 days and 1 year post-procedure
Safety endpoint
Total patients with SAEs within 90 days post-procedure
Time frame: 90 days
Safety endpoint
Incidence of neurological death within 90 days post-procedure
Time frame: 90 days
Safety endpoint
Incidence of procedural serious complications within 30 days post-procedure: * symptomatic procedure-related intracranial hemorrhage * any procedure-related intracranial hemorrhage * any procedure-related neurological deficit * CNS infection caused by procedure * procedure-related artery dissection, vessel wall damage and vessel perforation * procedure-related ischemic event * retroperitoneal hematoma (femoral access)/wrist hematoma (radial access) * neuropathy at the puncture site * contrast agent allergy or encephalopathy
Time frame: 30 days
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is active, not recruiting, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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