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| ID | Type | Description | Link |
|---|---|---|---|
| DRKS00020465 | Other Identifier | German Clinical Trials Register |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgery plus endovascular MMA embolization | Experimental |
| |
| Surgery alone | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgery plus endovascular MMA embolization | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| cSDH recurrence rates after surgery | A recurrence occurs when at least one of the following criteria is met:
| Within three months of follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Impairment due to neurological deficits assessed by the modified Rankin Scale | Modified Rankin scale ranges from 0 (no symptoms) to 5 (severe disability) | Evaluated at three months after baseline |
| Number of recurrence-associated complications |
| Measure | Description | Time Frame |
|---|---|---|
| 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%. | Within three months of follow-up |
| Predisposition of the genetic variants F13A1 rs2815822 and F13B rs12134960 for factor XIII deficiency |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Johannes Lemcke, PD Dr. med. | Contact | 00493056813701 | johannes.lemcke@ukb.de | |
| Leonie Goelz, Dr. med. | Contact | leonie.goelz@ukb.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unfallkrankenhaus Berlin | Recruiting | Berlin | State of Berlin | 12683 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35996195 | Derived | 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. |
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| ID | Term |
|---|---|
| D020200 | Hematoma, Subdural, Chronic |
| ID | Term |
|---|---|
| D006408 | Hematoma, Subdural |
| D020198 | Intracranial Hemorrhage, Traumatic |
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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|
| Surgery alone | Procedure | Evacuation of cSDH |
|
Examined on a binary scale
| Within three months of follow-up |
| Number of complications associated with interventional therapy | Examined on a binary scale | Within three months of follow-up |
The existence of genetic variants F13A1 rs2815822 or F13B rs12134960 in the blood of the subjects is determined on a binary scale. |
| Within three months of follow-up |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006406 | Hematoma |
| D006470 | Hemorrhage |
| D014947 | Wounds and Injuries |