drugset / Trial / NCT03353259

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

NCT03353259

Phase 2/3 Terminated 382 enrolled Oslo University Hospital
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

EvaluationDrugModalityDoseRoute
Subject Tocilizumab Monoclonal antibody 162 mg Subcutaneous
Subject Tranexamic Acid Small molecule 500 mg Oral

Indications

No indication recorded.