Clinical trial NCT05327933: Preventing Recurrences of Chronic Subdural Hematoma in Adult Patients by Middle Meningeal Artery Embolization
Official title: Middle Meningeal Artery Embolization Minimizes Burdensome Recurrence Rates After Newly Diagnosed Chronic Subdural Hematoma Evacuation (MEMBRANE)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hematoma, Subdural, Chronic
Lead sponsor: Unfallkrankenhaus Berlin
Sponsor class: OTHER
First posted: 2022-04-14
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Patients with a chronic subdural hematoma (cSDH), that is, a blood accumulation between two meninges developing over a long period of time, often have recurrent bleedings after an initial operation. The study aims to show that additional surgery reduces the risk of recurrent bleeding.

The additional procedure aims to block small blood vessels in the skull with tiny plastic particles. The small blood vessels are embolized using X-rays and a contrast medium and a fine tube that is inserted into the diseased vessels of the head via the groin.

Patients of full age who have undergone burr hole trepanation as a first operation, i.e. a blood drain through a hole in the cranial cavity, can participate in the study. Participating patients are randomly assigned to a control group with treatment according to clinical routine or a treatment group with an additional occlusion of the blood vessels in the skull. In addition, patients can consent to a genetic test to determine the relationship between a coagulation factor and the risk of recurrence of the hematoma. In order to record the test results, check-up examinations are carried out after one and three months.


Eligibility criteria: Inclusion Criteria:

1. Patients who have undergone surgery by means of one or more burr hole trepanations during the first manifestation of a cSDH (unihemispherical or bihemispherical) detected by computed tomography or magnetic resonance tomography
2. Age ≥18 years
3. Sufficient compliance and ability to consent
4. Patient's informed consent for surgical as well as endovascular interventional procedure and participation in the study

Exclusion Criteria:

1. Conservatively treated cSDH
2. Radiological evidence of an acute or subacute subdural hematoma, subarachnoid hemorrhage, intracerebral hematoma or epidural hematoma
3. Surgical technique: craniotomy, craniectomy, bilateral burr hole trepanation
4. Angiography cannot be performed within 72 hours after surgery
5. Age \<18 years
6. Supervisory relationship
7. Pregnancy
8. Lack of informed consent
9. Lack of compliance
10. Homozygous factor XIII deficiency with residual activity \<10%

Primary outcomes:
measure: cSDH recurrence rates after surgery
timeFrame: Within three months of follow-up
Secondary outcomes:
measure: Impairment due to neurological deficits assessed by the modified Rankin Scale
timeFrame: Evaluated at three months after baseline
measure: Number of recurrence-associated complications
timeFrame: Within three months of follow-up
measure: Number of complications associated with interventional therapy
timeFrame: Within three months of follow-up
Other outcomes:
measure: Relationship between factor XIII deficiency and risk of recurrence
timeFrame: Within three months of follow-up
measure: Predisposition of the genetic variants F13A1 rs2815822 and F13B rs12134960 for factor XIII deficiency
timeFrame: Within three months of follow-up
Locations:
city: Berlin
country: Germany
facility: Unfallkrankenhaus Berlin
Study officials:
References:
citation: Hoenning A, Lemcke J, Rot S, Stengel D, Hoppe B, Zappel K, Schuss P, Mutze S, Goelz L. Middle Meningeal Artery Embolization Minimizes Burdensome Recurrence Rates After Newly Diagnosed Chronic Subdural Hematoma Evacuation (MEMBRANE): study protocol for a randomized controlled trial. Trials. 2022 Aug 22;23(1):703. doi: 10.1186/s13063-022-06506-3.