Chronic Subdural HematomaPREMMANCT06466733
Puerto Rico Embolization of the Middle Meningeal Artery for the Treatment of Chronic Subdural Hematoma Trial (PREMMA)
A study testing Embolization of the middle meningeal artery and Surgical Evacuation via burr hole or craniotomy in people with Chronic Subdural Hematoma, run by Juan M. Ramos Acevedo.
Trial summary
Puerto Rico Embolization of the Middle Meningeal Artery (PREMMA) trial is a multi-center, parallel, prospective, superiority, randomized controlled trial with concealed allocation comparing reoperation rates and neurological outcomes in patients with chronic subdural hematoma that receive treatment via embolization of… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Chronic Subdural Hematoma
- What is being tested?
- Embolization of the middle meningeal artery and Surgical Evacuation via burr hole or craniotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 658 participants
- Where
- No sites listed yet
- Study dates
- May 2025to Jul 2032
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 21
- Speak and understand Spanish or English
- Resident of Puerto Rico
- Glasgow coma scale ≥ 14/15
- Presence of cSDH on non-contrast computed tomography (NCCT) or magnetic resonance imaging (MRI)
- Neurological indication for treatment of cSDH (Markwalder scale ≤ 2)
- No previous surgical or endovascular treatment for symptomatic cSDH
- Signed informed consent for participation in the study by the patient or legally authorized representative
Who cannot join
- Acute subdural hematoma
- Focal, non-hemispheric localization of cSDH
- Evidence of other lesions associated with cSDH, such as neoplasms, vascular lesions, or additional epidural, subarachnoid, or parenchymal hemorrhage on non-contrast computed tomography or magnetic resonance imaging
- Imaging evidence of skull fracture over the subdural hematoma
- Presence of any cerebrospinal fluid (CSF) shunt
- Imaging evidence of midline shift ≥ 10 mm
Show all 15Show fewer
- Imaging evidence of basal cistern effacement
- Imaging evidence of dilatation of lateral ventricles
- Imaging evidence of uncal herniation
- Modified Rankin scale ≥ 3 before developing symptoms associated with cSDH
- Contraindications for angiography (i.e., complex anatomy or kidney failure)
- Comorbidity making follow-up impossible
- Pregnancy
- Vulnerable patients, including homeless patients, incarcerated patients, and mentally ill patients without appropriate medical decision-making proxies that the physician believes are incapable of appropriately assessing the risks of the procedure
- Absence of medical insurance
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Puerto Rico Embolization of the Middle Meningeal Artery (PREMMA) trial is a multi-center, parallel, prospective, superiority, randomized controlled trial with concealed allocation comparing reoperation rates and neurological outcomes in patients with chronic subdural hematoma that receive treatment via embolization of the middle meningeal artery versus surgical evacuation via burr hole trephination or craniotomy.
Read the detailed description
Chronic subdural hematoma (cSDH) is a collection of fluid and blood breakdown products that evolves over weeks to months in the subdural space. This condition is more common among people older than 65 years and has been associated with increased use of antithrombotic therapy among this population. The World population is rapidly aging; thus, the investigators expect the number of patients with cSDH will increase. The United Nations World Social Report places Puerto Rico in the 7th place of countries with the largest share of people aged 65 years or over. This pathology burdens healthcare systems; therefore, assessing the feasibility of treatment modalities for cSDH that are less invasive, have lower procedural risks, and have lower recurrence rates that require additional surgical intervention is essential.
The standard of care for symptomatic cSDH is the surgical evacuation (SE) of the hematoma, with recurrence rates between 10-30% and surgical rescue indicated for most of these cases. Evacuation of the hematoma effectively relieves its mass effect but does not change the underlying pathophysiologic mechanism. In recent years, embolization of the middle meningeal artery (eMMA) has been shown to decrease the recurrence of chronic subdural hematoma and the need for revision burr hole or craniotomy. The PREMMA trial aims to compare embolization of the middle meningeal artery as stand-alone treatment for chronic subdural hematoma versus the standard of care, surgical evacuation.
- Conditions
- Chronic Subdural Hematoma
- Being tested
- Embolization of the middle meningeal artery, Surgical Evacuation via burr hole or craniotomy
- Keywords
- Chronic subdural hematoma, Embolization of the middle meningeal artery, Surgical evacuation, Hemorrhage, Intracranial hemorrhage, Cerebrovascular disease, Chronic disease
- Medical subject headings
- Hematoma, Subdural, Chronic, Hemorrhage, Intracranial Hemorrhages, Cerebrovascular Disorders, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Embolization of the middle meningeal arteryProcedure or surgery
Embolization of the middle meningeal artery ipsilateral to the chronic subdural hematoma is performed infusing embolic polyvinyl alcohol (PVA) microparticles.
Surgical Evacuation via burr hole or craniotomyProcedure or surgery
Also called Burr hole, Craniotomy
The standard of care for chronic subdural hematoma, burr hole or craniotomy are performed ipsilateral to the lesion.
| Study group | Role | What they receive |
|---|---|---|
| Endovascular Embolization | Experimental | Embolization of the middle meningeal artery Receives: Procedure: Embolization of the middle meningeal artery |
| Surgical Evacuation of Hematoma | Active comparator | Burr hole or craniotomy Receives: Procedure: Surgical Evacuation via burr hole or craniotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reoperation
Number of patients requiring reoperation due to recurrent chronic subdural hematoma.
Measured: 3 months, 6 months, and 12 months
Secondary outcomes (11)
Modified Rankin Scale (mRS)
The modified Rankin Scale (mRS) will assess neurological disability. The scale comprises seven levels, from 0 to 6, with higher scores indicating greater disability, and 6 indicating death.
Measured: Pre-operative, 24 hours, 2 weeks, 1.5 months, 3 months, 6 months, and 12 months
Glasgow Coma Scale (GCS)
The Glasgow coma scale (GCS) will assess consciousness level. GCS score can range from 3 (completely unresponsive) to 15 (completely alert and oriented).
Measured: Pre-operative, 24 hours, 2 weeks
Visual Analog Scale (VAS)
The visual analog scale (VAS) will assess pain levels. VAS represents the severity of pain from 0 "no pain" to 10 "very severe pain."
Measured: Pre-operative, 24 hours, 2 weeks, 1.5 months, 3 months, 6 months, 12 months
Quality of life (EQ-5D-5L)
Will be measured with the EuroQol 5 dimensions and 5 levels (EQ-5D-5L) grading scale.
Measured: Pre-operative, 2 weeks, 1.5 months, 3 months, 6 months, 12 months
Radiological outcomes
Will be measured by routine computed tomography compared with pre-operative images.
Measured: Pre-operative, 24 hours, 3 months, 6 months, 12 months
Technical success of embolization of the middle meningeal artery (eMMA)
The rate of unsuccessful eMMA due to technical failure or anatomical issues will be recorded.
Measured: 24 hours
Procedure-related complications
Any life-threatening event from enrollment to discharge will be recorded.
Measured: 24 hours, 2 weeks, 1.5 months, 3 months
Adverse events
Any unintentional injury or complication involving a prolonged stay, disability at discharge, or death caused by healthcare management, not the underlying disease, will be recorded.
Measured: 24 hours, 2 weeks, 1.5 months, 3 months
Post-operative morbidity
All surgical and/or medical complications that occur.
Measured: 24 hours, 2 weeks, 1.5 months, 3 months
Mortality
The number of participants among the total number of deaths.
Measured: 24 hours, 2 weeks, 30 days, 1.5 months, 3 months, 6 months, 12 months
Length of stay
The patient's hospitalization period.
Measured: From date of randomization until the date of discharge or date of death from any cause while patient is in hospital, whichever came first, assessed up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study startMay 2025 (estimated)
- Primary completionJul 2031 (estimated)
- Study completionJul 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for Chronic Subdural HematomaStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 658 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Juan M. Ramos Acevedo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Juan M. Ramos Acevedo, University of Puerto Rico
- Investigators
- Juan M Ramos Acevedo, MD, Principal investigator, University of Puerto Rico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06466733
- Sponsor's protocol ID
- 2305109135
- Acronym
- PREMMA
- Status last verified
- May 2025
- First submitted
- 15 May 2024
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ropper AH. Beneath a Tough Mother (Dura Mater) - Chronic Subdural Hematoma. N Engl J Med. 2020 Dec 31;383(27):2678-2680. doi: 10.1056/NEJMe2031257. Epub 2020 Dec 16. No abstract available.
PubMed 33326714Jung YG, Jung NY, Kim E. Independent predictors for recurrence of chronic subdural hematoma. J Korean Neurosurg Soc. 2015 Apr;57(4):266-70. doi: 10.3340/jkns.2015.57.4.266. Epub 2015 Apr 24. No abstract available.
PubMed 25932293Edlmann E, Giorgi-Coll S, Whitfield PC, Carpenter KLH, Hutchinson PJ. Pathophysiology of chronic subdural haematoma: inflammation, angiogenesis and implications for pharmacotherapy. J Neuroinflammation. 2017 May 30;14(1):108. doi: 10.1186/s12974-017-0881-y.
PubMed 28558815Moshayedi P, Liebeskind DS. Middle Meningeal Artery Embolization in Chronic Subdural Hematoma: Implications of Pathophysiology in Trial Design. Front Neurol. 2020 Aug 27;11:923. doi: 10.3389/fneur.2020.00923. eCollection 2020.
PubMed 32973670Henry J, Amoo M, Kissner M, Deane T, Zilani G, Crockett MT, Javadpour M. Management of Chronic Subdural Hematoma: A Systematic Review and Component Network Meta-analysis of 455 Studies With 103 645 Cases. Neurosurgery. 2022 Dec 1;91(6):842-855. doi: 10.1227/neu.0000000000002144. Epub 2022 Sep 28.
PubMed 36170165Dudoit T, Labeyrie PE, Deryckere S, Emery E, Gaberel T. Is systematic post-operative CT scan indicated after chronic subdural hematoma surgery? A case-control study. Acta Neurochir (Wien). 2016 Jul;158(7):1241-6. doi: 10.1007/s00701-016-2820-6. Epub 2016 May 5.
PubMed 27147520Chen FM, Wang K, Xu KL, Wang L, Zhan TX, Cheng F, Wang H, Chen ZB, Gao L, Yang XF. Predictors of acute intracranial hemorrhage and recurrence of chronic subdural hematoma following burr hole drainage. BMC Neurol. 2020 Mar 13;20(1):92. doi: 10.1186/s12883-020-01669-5.
PubMed 32169039Thomas PAW, Mitchell PS, Marshman LAG. Early Postoperative Morbidity After Chronic Subdural Hematoma: Predictive Usefulness of the Physiological and Operative Severity Score for Enumeration of Mortality and Morbidity, American College of Surgeons National Surgical Quality Improvement Program, and American Society of Anesthesiologists Grade in a Prospective Cohort. World Neurosurg. 2019 Apr;124:e489-e497. doi: 10.1016/j.wneu.2018.12.119. Epub 2019 Jan 3.
PubMed 30610985Kolias AG, Chari A, Santarius T, Hutchinson PJ. Chronic subdural haematoma: modern management and emerging therapies. Nat Rev Neurol. 2014 Oct;10(10):570-8. doi: 10.1038/nrneurol.2014.163. Epub 2014 Sep 16.
PubMed 25224156Santarius T, Kirkpatrick PJ, Ganesan D, Chia HL, Jalloh I, Smielewski P, Richards HK, Marcus H, Parker RA, Price SJ, Kirollos RW, Pickard JD, Hutchinson PJ. Use of drains versus no drains after burr-hole evacuation of chronic subdural haematoma: a randomised controlled trial. Lancet. 2009 Sep 26;374(9695):1067-73. doi: 10.1016/S0140-6736(09)61115-6.
PubMed 19782872Nouri A, Gondar R, Schaller K, Meling T. Chronic Subdural Hematoma (cSDH): A review of the current state of the art. Brain Spine. 2021 Nov 2;1:100300. doi: 10.1016/j.bas.2021.100300. eCollection 2021.
PubMed 36247395Desir LL, Narayan V, Ellis J, Gordon D, Langer D, Ortiz R, Serulle Y. Middle Meningeal Artery Embolization in the Management of Chronic Subdural Hematoma: a Comprehensive Review of Current Literature. Curr Neurol Neurosci Rep. 2023 Apr;23(4):109-119. doi: 10.1007/s11910-023-01262-6. Epub 2023 Apr 11.
PubMed 37037979Miah IP, Tank Y, Rosendaal FR, Peul WC, Dammers R, Lingsma HF, den Hertog HM, Jellema K, van der Gaag NA; Dutch Chronic Subdural Hematoma Research Group. Radiological prognostic factors of chronic subdural hematoma recurrence: a systematic review and meta-analysis. Neuroradiology. 2021 Jan;63(1):27-40. doi: 10.1007/s00234-020-02558-x. Epub 2020 Oct 22.
PubMed 33094383Rauhala M, Helen P, Huhtala H, Heikkila P, Iverson GL, Niskakangas T, Ohman J, Luoto TM. Chronic subdural hematoma-incidence, complications, and financial impact. Acta Neurochir (Wien). 2020 Sep;162(9):2033-2043. doi: 10.1007/s00701-020-04398-3. Epub 2020 Jun 10.
PubMed 32524244Almenawer SA, Farrokhyar F, Hong C, Alhazzani W, Manoranjan B, Yarascavitch B, Arjmand P, Baronia B, Reddy K, Murty N, Singh S. Chronic subdural hematoma management: a systematic review and meta-analysis of 34,829 patients. Ann Surg. 2014 Mar;259(3):449-57. doi: 10.1097/SLA.0000000000000255.
PubMed 24096761
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Puerto Rico Embolization of the Middle Meningeal Artery for the Treatment of Chronic Subdural Hematoma Trial (PREMMA)
- ClinicalTrials.gov ID
- NCT06466733
- Acronym / sponsor ID
- PREMMA / 2305109135
- Conditions
- Chronic Subdural Hematoma
- Keywords
- Chronic subdural hematoma, Embolization of the middle meningeal artery, Surgical evacuation, Hemorrhage, Intracranial hemorrhage, Cerebrovascular disease, Chronic disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 658 participants (estimated)
- Lead sponsor
- Juan M. Ramos AcevedoUniversity, hospital or other
- Study start
- May 2025 (estimated)
- Primary completion
- Jul 2031 (estimated)
- Study completion
- Jul 2032 (estimated)
- First posted
- 20 Jun 2024 (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.
Puerto Rico Embolization of the Middle Meningeal Artery (PREMMA) trial is a multi-center, parallel, prospective, superiority, randomized controlled trial with concealed allocation comparing reoperation rates and neurological outcomes in patients with chronic subdural hematoma that receive treatment via embolization of the middle meningeal artery versus surgical evacuation via burr hole trephination or craniotomy.
Detailed description
Chronic subdural hematoma (cSDH) is a collection of fluid and blood breakdown products that evolves over weeks to months in the subdural space. This condition is more common among people older than 65 years and has been associated with increased use of antithrombotic therapy among this population. The World population is rapidly aging; thus, the investigators expect the number of patients with cSDH will increase. The United Nations World Social Report places Puerto Rico in the 7th place of countries with the largest share of people aged 65 years or over. This pathology burdens healthcare systems; therefore, assessing the feasibility of treatment modalities for cSDH that are less invasive, have lower procedural risks, and have lower recurrence rates that require additional surgical intervention is essential.
The standard of care for symptomatic cSDH is the surgical evacuation (SE) of the hematoma, with recurrence rates between 10-30% and surgical rescue indicated for most of these cases. Evacuation of the hematoma effectively relieves its mass effect but does not change the underlying pathophysiologic mechanism. In recent years, embolization of the middle meningeal artery (eMMA) has been shown to decrease the recurrence of chronic subdural hematoma and the need for revision burr hole or craniotomy. The PREMMA trial aims to compare embolization of the middle meningeal artery as stand-alone treatment for chronic subdural hematoma versus the standard of care, surgical evacuation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endovascular Embolization | Experimental | Procedure: Embolization of the middle meningeal arteryEmbolization of the middle meningeal artery |
| Surgical Evacuation of Hematoma | Active comparator | Procedure: Surgical Evacuation via burr hole or craniotomyBurr hole or craniotomy |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 21
- Speak and understand Spanish or English
- Resident of Puerto Rico
- Glasgow coma scale ≥ 14/15
- Presence of cSDH on non-contrast computed tomography (NCCT) or magnetic resonance imaging (MRI)
Key exclusion criteria (15 listed)
- Acute subdural hematoma
- Focal, non-hemispheric localization of cSDH
- Evidence of other lesions associated with cSDH, such as neoplasms, vascular lesions, or additional epidural, subarachnoid, or parenchymal hemorrhage on non-contrast computed tomography or magnetic resonance imaging
- Imaging evidence of skull fracture over the subdural hematoma
- Presence of any cerebrospinal fluid (CSF) shunt
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 |
|---|---|---|
| Embolization of the middle meningeal arteryEmbolization of the middle meningeal artery ipsilateral to the chronic subdural hematoma is performed infusing embolic polyvinyl alcohol (PVA) microparticles. | Procedure or surgery | Endovascular Embolization |
| Surgical Evacuation via burr hole or craniotomyAlso: Burr hole, CraniotomyThe standard of care for chronic subdural hematoma, burr hole or craniotomy are performed ipsilateral to the lesion. | Procedure or surgery | Surgical Evacuation of Hematoma |
Primary outcome
Reoperation
Time frame: 3 months, 6 months, and 12 months
Number of patients requiring reoperation due to recurrent chronic subdural hematoma.
11 secondary outcomes
Modified Rankin Scale (mRS)
Time frame: Pre-operative, 24 hours, 2 weeks, 1.5 months, 3 months, 6 months, and 12 months
Glasgow Coma Scale (GCS)
Time frame: Pre-operative, 24 hours, 2 weeks
Visual Analog Scale (VAS)
Time frame: Pre-operative, 24 hours, 2 weeks, 1.5 months, 3 months, 6 months, 12 months
Quality of life (EQ-5D-5L)
Time frame: Pre-operative, 2 weeks, 1.5 months, 3 months, 6 months, 12 months
Radiological outcomes
Time frame: Pre-operative, 24 hours, 3 months, 6 months, 12 months
Technical success of embolization of the middle meningeal artery (eMMA)
Time frame: 24 hours
Procedure-related complications
Time frame: 24 hours, 2 weeks, 1.5 months, 3 months
Adverse events
Time frame: 24 hours, 2 weeks, 1.5 months, 3 months
Post-operative morbidity
Time frame: 24 hours, 2 weeks, 1.5 months, 3 months
Mortality
Time frame: 24 hours, 2 weeks, 30 days, 1.5 months, 3 months, 6 months, 12 months
Length of stay
Time frame: From date of randomization until the date of discharge or date of death from any cause while patient is in hospital, whichever came first, assessed up to 90 days
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 7 May 2025.
- Background: PubMed 33326714Ropper AH. Beneath a Tough Mother (Dura Mater) - Chronic Subdural Hematoma. N Engl J Med. 2020 Dec 31;383(27):2678-2680. doi: 10.1056/NEJMe2031257. Epub 2020 Dec 16. No abstract available.
- Background: PubMed 25932293Jung YG, Jung NY, Kim E. Independent predictors for recurrence of chronic subdural hematoma. J Korean Neurosurg Soc. 2015 Apr;57(4):266-70. doi: 10.3340/jkns.2015.57.4.266. Epub 2015 Apr 24. No abstract available.
- Background: PubMed 28558815Edlmann E, Giorgi-Coll S, Whitfield PC, Carpenter KLH, Hutchinson PJ. Pathophysiology of chronic subdural haematoma: inflammation, angiogenesis and implications for pharmacotherapy. J Neuroinflammation. 2017 May 30;14(1):108. doi: 10.1186/s12974-017-0881-y.
- Background: PubMed 32973670Moshayedi P, Liebeskind DS. Middle Meningeal Artery Embolization in Chronic Subdural Hematoma: Implications of Pathophysiology in Trial Design. Front Neurol. 2020 Aug 27;11:923. doi: 10.3389/fneur.2020.00923. eCollection 2020.
- Background: PubMed 36170165Henry J, Amoo M, Kissner M, Deane T, Zilani G, Crockett MT, Javadpour M. Management of Chronic Subdural Hematoma: A Systematic Review and Component Network Meta-analysis of 455 Studies With 103 645 Cases. Neurosurgery. 2022 Dec 1;91(6):842-855. doi: 10.1227/neu.0000000000002144. Epub 2022 Sep 28.
- Background: PubMed 27147520Dudoit T, Labeyrie PE, Deryckere S, Emery E, Gaberel T. Is systematic post-operative CT scan indicated after chronic subdural hematoma surgery? A case-control study. Acta Neurochir (Wien). 2016 Jul;158(7):1241-6. doi: 10.1007/s00701-016-2820-6. Epub 2016 May 5.
- Background: PubMed 32169039Chen FM, Wang K, Xu KL, Wang L, Zhan TX, Cheng F, Wang H, Chen ZB, Gao L, Yang XF. Predictors of acute intracranial hemorrhage and recurrence of chronic subdural hematoma following burr hole drainage. BMC Neurol. 2020 Mar 13;20(1):92. doi: 10.1186/s12883-020-01669-5.
- Background: PubMed 30610985Thomas PAW, Mitchell PS, Marshman LAG. Early Postoperative Morbidity After Chronic Subdural Hematoma: Predictive Usefulness of the Physiological and Operative Severity Score for Enumeration of Mortality and Morbidity, American College of Surgeons National Surgical Quality Improvement Program, and American Society of Anesthesiologists Grade in a Prospective Cohort. World Neurosurg. 2019 Apr;124:e489-e497. doi: 10.1016/j.wneu.2018.12.119. Epub 2019 Jan 3.
- Background: PubMed 25224156Kolias AG, Chari A, Santarius T, Hutchinson PJ. Chronic subdural haematoma: modern management and emerging therapies. Nat Rev Neurol. 2014 Oct;10(10):570-8. doi: 10.1038/nrneurol.2014.163. Epub 2014 Sep 16.
- Background: PubMed 19782872Santarius T, Kirkpatrick PJ, Ganesan D, Chia HL, Jalloh I, Smielewski P, Richards HK, Marcus H, Parker RA, Price SJ, Kirollos RW, Pickard JD, Hutchinson PJ. Use of drains versus no drains after burr-hole evacuation of chronic subdural haematoma: a randomised controlled trial. Lancet. 2009 Sep 26;374(9695):1067-73. doi: 10.1016/S0140-6736(09)61115-6.
- Background: PubMed 36247395Nouri A, Gondar R, Schaller K, Meling T. Chronic Subdural Hematoma (cSDH): A review of the current state of the art. Brain Spine. 2021 Nov 2;1:100300. doi: 10.1016/j.bas.2021.100300. eCollection 2021.
- Background: PubMed 37037979Desir LL, Narayan V, Ellis J, Gordon D, Langer D, Ortiz R, Serulle Y. Middle Meningeal Artery Embolization in the Management of Chronic Subdural Hematoma: a Comprehensive Review of Current Literature. Curr Neurol Neurosci Rep. 2023 Apr;23(4):109-119. doi: 10.1007/s11910-023-01262-6. Epub 2023 Apr 11.
- Individual participant dataSharing planned: No
Related trials for Chronic Subdural Hematoma
RecruitingObservational study
Effect of Different Intravenous Fluids on Post-operative Chronic Subdural Hematoma Size and Recurrence
Chronic Subdural Hematoma
Recruiting
Middle Meningeal Artery Embolisation in Chronic Subdural Hematoma
Chronic Subdural Hematoma
Not yet recruitingPhase 4
Propofol Target-Controlled Infusion Versus Dexmedetomidine for Sedation During Chronic Subdural Hematoma Surgery Under Local Anesthesia
Chronic Subdural Hematoma
RecruitingObservational study
Study On Histoacryl Used For Embolization Of Middle Meningeal Artery (MMA) In Chronic Subdural Hematoma (CSDH)
Subdural Hematoma, Subdural Hematoma, Chronic
Recruiting
MMA Embolization With NeoCast for Subacute and Chronic Subdural Hematoma
Subdural Hematoma
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.
Juan M Ramos Acevedo, MD principal investigator
University of Puerto Rico
Questions about this trial
What is this clinical trial studying?
A study testing Embolization of the middle meningeal artery and Surgical Evacuation via burr hole or craniotomy in people with Chronic Subdural Hematoma, run by Juan M. Ramos Acevedo.
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 15 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: opening soon, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Maria M Garcia Perez (939-417-4432, dra.garcia.neurosx@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reoperation (time frame: 3 months, 6 months, and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06466733, which also lists 34 linked publications.
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 7 May 2025.