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

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

Outcome

Met primary endpoint

Stopped: “DMC concluded that the results of 382 included patients were clear.”

paper Both TXA (absolute risk reduction 5.6%, 95% CI 1.3%-11.4%, P = .018) and TXA-TCZ (6.3%, 95% CI 3.2%-12.0%, P = .003) significantly reduced recurrence compared with control. PMID 42423601 ↗

Publications

• 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.

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.