Prospective Study on the Use of Middle Meningeal Artery Embolization for Chronic Subdural Haematoma

NCT04500795 | Withdrawn

• 1 other identifier: GWMMAE01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Subdural haematoma is a common neurosurgical condition that results in different levels of neurological deficits in patients. It can be further classified into acute and chronic, which have different pathophysiology. Acute haematoma is a common result of traumatic injuries involving the tearing of the bridging veins, while chronic subdural haematoma can be both a result of traumatic injuries or recurrence following surgical management of the acute counterpart. For symptomatic patients, they are often surgically managed by haematoma drainage via burr-hole drainage and craniotomy. Recurrent bleeding following close monitor or surgical evacuation of haematoma is however very high. Recent studies approximate the recurrence rate of 2%-33.3%. Recent evidence suggests the angiogenesis of middle meningeal arteries (MMA) in response to inflammation and healing process contributes to the development of chronic subdural haematoma, and its high recurrence chance. Several studies have looked into the use of middle meningeal artery embolization to halt the bleeding of a chronic subdural haematoma, and have found promising results in terms of haematoma reduction and prevention of surgical rescues.

Conditions

Chronic Subdural Hematoma; Subdural Hematoma

Keywords

chronic subdural hematoma; subdural hematoma; head injury; middle meningeal artery; hemorrhage; embolization

Outcome Measures

Primary Outcomes (1)

• Percentage volume change of recurrent haematoma

  Primary outcome of the studies is the percentage volume change of recurrent haematoma measured by serial CT brain scans after embolization (embolization group) or haematoma removal (control group).

  From date of recruitmnent until the date of first documented progression or date of death from any cause or at 6 months, whichever came first

Secondary Outcomes (2)

• Number of patients with treatment failure

  From date of recruitment until the date of first documented progression or date of death from any cause or at 6 months, whichever came first

• Number of patients with 30-day morbidities and mortality

  30 days following the day of recruitment

Study Arms (2)

Embolization Group

EXPERIMENTAL

Patients with residual or recurrent haematoma (higher than 10mm thickness of haematoma at any dimension) following prior surgical evacuation of haematoma will be admitted to the Embolization Group and undergo embolization of MMA. Serial CT scans will be taken at times of presentation of the residual or recurrent haematoma, 1-day, 1-week, 1-month, 3-month, and 6-month following embolization. Size of haematoma will be measured for comparison to the Control Group. Clinical examinations will be done at the same setting.

Procedure: Middle meningeal artery embolization

Control Group

NO INTERVENTION

All symptomatic patients (headache unresponsive to analgesic or neurological deficits including focal neurological deficits, deteriorated consciousness, headache, seizures, and other signs or symptoms suggestive of SDH as the cause) will undergo haematoma evacuation either by burr-hole drainage or craniotomy. Their response to treatment, neurological status, and CT scans will be monitored. Asymptomatic patients will be monitored radiologically (CT) every 2-4 weeks. The decision for surgical evacuation of haematoma will be based on CT findings (increasing haematoma size) and presentation of symptoms or neurological deficits. They remain in the control group should they refuse embolization of MMA. The size of haematoma will be measured continuously based on CT scans taken at times of presentation, 1-day, 1-week, 1-month, 3-month, and 6-month post-op. Size of haematoma, residual or recurrent will be measured for comparison to the Embolization Group.

Interventions

Middle meningeal artery embolization PROCEDURE

MMA embolization will be performed with a liquid embolization agent with local anaesthesia. Selective angiography will be performed before embolization to select MMA branch targets and detect potentially dangerous collateral vessels. If no dangerous collaterals are found, MMA branches supplying to the dura of convexity will be targeted and embolized according to findings of the selective angiography using a liquid embolization agent. If dangerous collaterals are identified, the microcatheter will be advanced more distally or the collaterals will be coiled prior to embolization. Procedure will be concluded once the flow stasis of MMA is confirmed. Embolization is considered successful if all MMA targets are embolized without procedural complications. Patients with existing use of antiplatelet or anticoagulation medication will not undergo medication reversal for the embolization procedure.

Embolization Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients (age 18 or above) with chronic subdural haematoma diagnosed by computed tomography and clinical presentation.

You may not qualify if:

• SDH with thickness of 10mm or less, lack of mass effect.
• SDH secondary to existing conditions (brain tumour, arachnoid cyst, spontaneous intracranial hypotension, previous craniotomy not due to chronic SDH)
• Patients in poor medication condition or with life expectancy less than 6 months.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Department of Surgery, The Chinese University of Hong Kong

Hong Kong, China

Location

MeSH Terms

Conditions

Hematoma, Subdural, Chronic; Hematoma, Subdural; Craniocerebral Trauma; Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematoma; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Patients divided into two groups, embolization group and control (conventional) group. Patients remain in control group if they refuse embolization.

Study Record Dates

• First Submitted: August 4, 2020
• First Posted: August 5, 2020
• Study Start: January 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: February 21, 2024

Record last verified: 2024-02

Locations

CN (1)