NCT03353259

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

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 382 (actual)
• Sponsor: Oslo University Hospital · Academic / Other
• Sex: All
• Age: 55 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Chronic Subdural Hematoma

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Tranexamic acid and Tocilizumab	The first intervention is Tranexamic acid, The second intervention is Tocilizumab

Timeline

• Start date: 2017-11-28
• Primary completion: 2021-02-28
• Completion: 2021-09-01
• First posted: 2017-11-27
• Last updated: 2021-10-13

Locations

1 site across 1 country: Norway