The addition of embolization of the middle meningeal artery will reduce recurrent surgery rate in symptomatic chronic subdural hematoma patients.
Bron
Verkorte titel
Aandoening
Chronic subdural hematoma
Ondersteuning
Onderzoeksproduct en/of interventie
Geen registraties gevonden.
Uitkomstmaten
Primaire uitkomstmaten
- The difference in reoperation rate between the control group and the intervention group
Achtergrond van het onderzoek
Chronic subdural hematoma (cSDH) is a frequent neurosurgical disease, especially in the elderly. Most cSDH patients (75%) require burr hole evacuation in order to alleviate their sometimes life-threatening symptoms. One of the biggest disadvantages of burr hole evacuation is that 10-30% of the patients eventually need recurrent surgery for their cSDH. Embolization of the middle meningeal artery is a new treatment for cSDH of which its efficacy has been investigated in small cohort studies and case series. These studies showed a significant reduction in recurrent surgery rate (<5%). The goal of this study is to investigate whether the addition of peri-operative embolization of the middle meningeal artery to standard treatment (burr hole evacuation), lowers recurrent surgery rate in a randomized controlled trial.
Doel van het onderzoek
The addition of embolization of the middle meningeal artery will reduce recurrent surgery rate in symptomatic chronic subdural hematoma patients.
Onderzoeksopzet
First presentation:
Evaluation of baseline parameters (EMV, mRS, mNIHSS, Barthel-index)
During admission for surgery/embolization:
Complications of embolization
8 weeks after intervention:
Evaluation of hematoma recurrence, reoperation rate, mortality, neurological functioning (mNIHSS, MOCA, GCS) and care and health-related costs (iMCQ and iPCQ).
16 weeks after intervention
Evaluation of hematoma recurrence, reoperation rate, mortality, neurological functioning (mNIHSS, MOCA, GCS) and care and health-related costs (iMCQ and iPCQ).
24 weeks after intervention
Evaluation of hematoma recurrence, reoperation rate, mortality, neurological functioning (mNIHSS, MOCA, GCS), quality of life (SF-36, EQ-5D-5L), performance in activities of daily living (Barthel), modified Rankin Scale and care and health-related costs (iMCQ and iPCQ).
Onderzoeksproduct en/of interventie
Peri-operative embolization of the middle meningeal artery (until 72 hours after burr-hole evacuation).
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- CT-confirmed diagnosis of cSDH
- Primary surgical treatment based on clinical symptoms (progressive neurological deficits).
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Significant contraindication to angiography (eg. allergy for contrast)
- Structural causes for subdural hemorrhage, e.g. arachnoid cysts, cortical vascular malformations and a history of cranial surgery in the previous 365 days
- Inability to obtain informed consent from the patient or legal representative (when the patient has a depressed level of consciousness), including language barrier.
- Monocular blindness on contralateral side of the hematoma
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiƫnten Data (IPD)
Toelichting
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL8940 |
Ander register | METC AMC : ABR: NL71901.018.20 |