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

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.

Study Overview

• Status: Terminated
• Conditions: Chronic Subdural Hematoma
• Intervention / Treatment: Combination product: Tranexamic acid and Tocilizumab

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.

• Study Type: Interventional
• Enrollment (Actual): 382
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0424
    • Milo Stanisic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 51 years to 96 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: SS-TG; Standard surgery using burr-hole procedure, irrigation and drainage.
Active Comparator: SS-TXA-TG; Standard surgery using burr-hole procedure, irrigation and drainage combined withTranexamic acid (Cyklokapron) administration. Cyklokapron tablets will be administered postoperatively in dosage 500 mg twice a day until complete hematoma disappearance.	Combination product: Tranexamic acid and Tocilizumab; The first intervention is Tranexamic acid, The second intervention is Tocilizumab; Other Names: Cyklokapron and RoActemra
Active Comparator: SS-TXA-RoA; Standard surgery using burr-hole procedure, irrigation and drainage combined with Tranexamic acid (Cyklokapron) and Tocilizumab (RoActemra) administration. Cyklokapron tablets will be administered postoperatively in dosage 500 mg twice a day combined with RoActemra subcutaneous injection of 162 mg once a week until complete hematoma disappearance.	Combination product: Tranexamic acid and Tocilizumab; The first intervention is Tranexamic acid, The second intervention is Tocilizumab; Other Names: Cyklokapron and RoActemra

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Investigators: Principal Investigator: Milo Stanisic, Oslo University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2017
• Primary Completion (Actual): February 28, 2021
• Study Completion (Actual): September 1, 2021

Study Registration Dates

• First Submitted: October 17, 2017
• First Submitted That Met QC Criteria: November 22, 2017
• First Posted (Actual): November 27, 2017

Study Record Updates

• Last Update Posted (Actual): October 13, 2021
• Last Update Submitted That Met QC Criteria: October 5, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Hemorrhage; Craniocerebral Trauma; Trauma, Nervous System; Intracranial Hemorrhages; Intracranial Hemorrhage, Traumatic; Hematoma; Hematoma, Subdural; Hematoma, Subdural, Chronic; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: 2016/1512/REK nord; 2017-001670-42 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No