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NCT03353259 Clinical Trial

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

Chronic Subdural Hematoma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03353259
Other study ID # 2016/1512/REK nord
Secondary ID 2017-001670-42
Status Terminated
Phase Phase 2/Phase 3
First received
Last updated
Start date November 28, 2017
Est. completion date September 1, 2021

Study information
Verified date September 2021
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 382
Est. completion date September 1, 2021
Est. primary completion date February 28, 2021
Accepts healthy volunteers No
Gender All
Age group 55 Years to 100 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Combination Product:
• Tranexamic acid and Tocilizumab
The first intervention is Tranexamic acid, The second intervention is Tocilizumab

Locations
Country Name City State
Norway Milo Stanisic Oslo

Sponsors (1)
Lead Sponsor Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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.
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