Tocilizumab (RoActemra) and Tranexamic Acid (Cyklokapron) Used as Adjuncts to Chronic Subdural Hematoma Surgery

Study Overview
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Brief Summary
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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: effectively decrease the rate of lesion recurrence requiring re-operation, effectively shorten the time of lesion resolution. 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.

Detailed Description
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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.

Official Title
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Tocilizumab (RoActemra) and Tranexamic Acid (Cyklokapron) Used as Adjuncts to Chronic Subdural Hematoma Surgery

Conditions
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Chronic Subdural Hematoma

Intervention / Treatment
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* Combination Product: Tranexamic acid and Tocilizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with informed consent, without presenting of any known contraindication for the use of Tranexamic acid and Tocilizumab. Exclusion Criteria: patients or relatives who refused to consent, presenting of any known contraindication for the use of Tranexamic acid and Tocilizumab.

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: SS-TG<br>Standard surgery using burr-hole procedure, irrigation and drainage. | |
| Active Comparator: SS-TXA-TG<br>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. | Combination Product: Tranexamic acid and Tocilizumab<br>* The first intervention is Tranexamic acid, The second intervention is Tocilizumab<br>* Other names: Cyklokapron and RoActemra;|
| Active Comparator: SS-TXA-RoA<br>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. | Combination Product: Tranexamic acid and Tocilizumab<br>* The first intervention is Tranexamic acid, The second intervention is Tocilizumab<br>* Other names: Cyklokapron and RoActemra;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. |