The role of middle meningeal artery embolisation as post-operative adjunct treatment for chronic subdural haematoma in adult patients

The efficacy of middle meningeal artery embolisation as post-operative adjunct treatment for unstable chronic subdural haematoma in adult patients

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12621000263897

Enrollment

Registered

2021-03-10

Start date

2022-05-01

Completion date

2024-04-01

Last updated

2023-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Chronic subdural haematoma (cSDH) is one of the most common neurosurgical conditions and its frequency continues to rise as a result of the aging population and the increasing use of anticoagulation and antiplatelet medications. While there are no established guidelines for its management, symptomatic cSDHs are usually treated with surgical evacuation. The reported recurrence rates following surgical evacuation in the literature vary widely from 2% to 37%, with most estimates ranging between 20% and 30%. Recent studies have suggested middle meningeal artery (MMA) embolisation to be a potential alternative treatment for cSDH. Numerous case reports and series have demonstrated MMA embolisation as a safe primary treatment for cSDHs or as an adjunct treatment following surgical evacuation. We aim to conduct the first randomised controlled trial to further confirm the efficacy of MMA embolisation. -Unstable cSDH patients who require urgent surgical evacuation on admission will be randomly allocated to receive post-operative MMA embolisation or observation (current standard treatment) during the same admission -We aim to demonstrate that post-operative MMA embolisation can reduce the rate of recurrent cSDH requiring repeat surgical evacuation

Interventions

Interventional group: Arm 1: Middle meningeal embolization following emergency surgical evacuation -Materials: Liquid embolic agent -Procedure: MMA embolization following emergency surgery (During the same admission, within 7 days ideally) -Duration: approx 60mins -Who: One of the 3 interventional neuroradiologists at The Canberra Hospital -One off treatment for chronic subdural haematoma -Location: The Canberra Hospital -Monitoring: A data safety monitoring board has been formed by 4 external reviewers including Dr Yash Gawarikar (Neurologist), Prof Christian Lueck (Neurologist), Dr Justin Pik (Neurosurgeon) and A/Prof John Cockburn (Radiologist). The board will review the operation reports and medical records to ensure the safety of the participants and that our complication rates are comparable to that observed in the literature.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Patient aged 18 or above with a diagnosis of chronic subdural haematoma. A patient is considered unstable (i.e. requiring emergency surgical evacuation on admission) if they fit one of more of the following criteria: 1. GCS <= 12 2. Lateralised weakness if present with power < 4/5 3. Other neurological deficits including seizures, dysphasia and gait disturbance

Exclusion criteria

Significant contraindications to surgery or angiography (eg. renal failure and allergies) Acute subdural haematoma Chronic subdural haematoma related to an underlying pathology other than trauma

Outcome results