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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-001670-42 | EudraCT Number |
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DMC concluded that the results of 382 included patients were clear.
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Primary objectives of the study are to investigate whether adjuvant treatment in the form of Tranexamic acid (Cyklokapron) and Tocilizumab (RoAcmera) to surgery in patients with chronic subdural hematomaina can:
Secondary objectives of the study are:1) assess the postoperative functional outcome and quality of life of participants, 2) assess the postoperative mortality of participants, 3) assess the treatment safety data, 4) assess the cure rate of participants.
Primary endpoints in the study are: 1) determine postoperative recurrence requiring reoperation using clinical examination and CT imaging, 2) determine the time period necessary to complete healing using clinical examination and CT imaging.
Secondary endpoints in the study are: 1) to determine the functional outcome and quality of life of the participants using questionnaires, 2) to determine the mortality of the participants related to chronic subdural hematoma, 3) to determine the treatments complications and adverse events of the participants, 4) to determine the curation using clinical examination and CT imaging.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SS-TG | No Intervention | Standard surgery using burr-hole procedure, irrigation and drainage. | |
| SS-TXA-TG | Active Comparator | Standard surgery using burr-hole procedure, irrigation and drainage combined withTranexamic acid (Cyklokapron) administration. Cyklokapron tablets will be administered postoperatively in dosage 500 mg twice a day until complete hematoma disappearance. |
|
| SS-TXA-RoA | Active Comparator | Standard surgery using burr-hole procedure, irrigation and drainage combined with Tranexamic acid (Cyklokapron) and Tocilizumab (RoActemra) administration. Cyklokapron tablets will be administered postoperatively in dosage 500 mg twice a day combined with RoActemra subcutaneous injection of 162 mg once a week until complete hematoma disappearance. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic acid and Tocilizumab | Combination Product | The first intervention is Tranexamic acid, The second intervention is Tocilizumab |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of Tocilizumab (RoActemra) and Tranexamic acid (Cyklokapron) used as Adjuncts to Chronic Subdural Hematoma Surgery Regarding Postoperative Recurrence | To determine the rate in number and percentage of postoperative recurrence requiring re-operation | 6 months period after the initial surgery. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Milo Stanisic | Oslo University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Milo Stanisic | Oslo | 0424 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42423601 | Derived | Ivanovic J, Ronning PA, Lashkarivand A, Mendoza EEM, Stanisic M. Tranexamic Acid and Tocilizumab as Adjuvant Therapy to Chronic Subdural Hematoma Surgery: A Randomized Controlled Trial. Neurosurgery. 2026 Jul 9. doi: 10.1227/neu.0000000000004157. Online ahead of print. |
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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 |
|---|---|
| D014148 | Tranexamic Acid |
| C502936 | tocilizumab |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
| 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 |