An interventional study of Surgery plus endovascular MMA embolization and Surgery alone in Hematoma, Subdural, Chronic, sponsored by Unfallkrankenhaus Berlin. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-30.
Sponsored by Unfallkrankenhaus Berlin · Not applicable, Interventional, and Prevention
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.
112 studies on the registry are indexed under Hematoma, Subdural, Chronic; 49 are open to participants now.
This study's planned enrollment of 154 is below the median of 185 across 86 interventional studies indexed under Hematoma, Subdural, Chronic.
Browse Hematoma, Subdural, Chronic studies →Unfallkrankenhaus Berlin is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Surgery plus endovascular MMA embolization
Procedure: Surgery alone
A micro catheter is inserted transfemorally into the branches of the middle meningeal artery (MMA) in a minimally invasive manner and the periphery is occluded using polyvinyl alcohol (PVA) particles to prevent future bleeding. If the desired catheter position cannot be achieved due to the anatomical conditions, a more proximal closure of the MMA using Onyx® or micro-electric coils is performed. Embolization of the MMA by PVA particles with sizes between 40-300 µm is preferred over embolization by coils and Onyx®, since the capillary network of the dura is entirely blocked when using particles. In order to identify the vessels to be closed, a digital subtraction angiography (DSA) is performed.
Evacuation of cSDH
cSDH recurrence rates after surgery
A recurrence occurs when at least one of the following criteria is met: * recurrent cSDH with at least the same volume (\>- 10%) compared to the findings at baseline and / or * recurrent cSDH which requires surgery
Time frame: Within three months of follow-up
Impairment due to neurological deficits assessed by the modified Rankin Scale
Modified Rankin scale ranges from 0 (no symptoms) to 5 (severe disability)
Time frame: Evaluated at three months after baseline
Number of recurrence-associated complications
Examined on a binary scale
Time frame: Within three months of follow-up
Number of complications associated with interventional therapy
Examined on a binary scale
Time frame: Within three months of follow-up
Relationship between factor XIII deficiency and risk of recurrence
Factor XIII deficiency is defined if the factor XIII concentration at baseline and/or the factor XIII activity after cryopreservation is \<70%.
Time frame: Within three months of follow-up
Predisposition of the genetic variants F13A1 rs2815822 and F13B rs12134960 for factor XIII deficiency
The existence of genetic variants F13A1 rs2815822 or F13B rs12134960 in the blood of the subjects is determined on a binary scale.
Time frame: Within three months of follow-up
Plan to share: No
Started May 2022 (actual). Primary completion is estimated for Oct 2025, 41 months after the start.
Of 44 interventional studies with no phase under Hematoma, Subdural, Chronic, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 37 and three quarters within 70. This study's planned 41 months is close to that.
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Unfallkrankenhaus Berlin