drugset / Trial / NCT03353259
Tocilizumab (RoActemra) and Tranexamic Acid (Cyklokapron) Used as Adjuncts to Chronic Subdural Hematoma Surgery
RandomizedParallel-groupOpen-labelTreatment
Summary
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: 1. effectively decrease the rate of lesion recurrence requiring re-operation, 2. 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.
Timeline
- Start
- 2017-11-28
- Primary completion
- 2021-02-28
- Completion
- 2021-09-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tocilizumab | Monoclonal antibody | 162 mg | Subcutaneous |
| Subject | Tranexamic Acid | Small molecule | 500 mg | Oral |
Indications
No indication recorded.