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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03353259
Recruitment Status : Recruiting
First Posted : November 27, 2017
Last Update Posted : May 27, 2020
Sponsor:
Information provided by (Responsible Party):
Milo Stanisic, Oslo University Hospital

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Chronic Subdural Hematoma Combination Product: Tranexamic acid and Tocilizumab Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tocilizumab (RoActemra) and Tranexamic Acid (Cyklokapron) Used as Adjuncts to Chronic Subdural Hematoma Surgery
Actual Study Start Date : November 28, 2017
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: Cyklokapron and RoActemra


Outcome Measures
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Primary Outcome Measures :
  1. Efficacy of Tocilizumab (RoActemra) and Tranexamic acid (Cyklokapron) used as Adjuncts to Chronic Subdural Hematoma Surgery Regarding Postoperative Recurrence [ Time Frame: 6 months period after the initial surgery. ]
    To determine the rate in number and percentage of postoperative recurrence requiring re-operation


Eligibility Criteria
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Ages Eligible for Study:   55 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03353259


Contacts
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Contact: Milo Stanisic, DrMedSci +47 93932382 mstanisi@ous-hf.no
Contact: Milo Stanisic +47 93932382 mstanisi@ous-hf.no

Locations
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Norway
Milo Stanisic Recruiting
Oslo, Norway, 0424
Contact: Milo Stanisic, DrMedSci    +4793932382    mstanisi@ous-hf.no   
Sponsors and Collaborators
Oslo University Hospital
Investigators
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Principal Investigator: Milo Stanisic Oslo University Hospital
More Information
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Responsible Party: Milo Stanisic, Principal Investigator, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT03353259    
Other Study ID Numbers: 2016/1512/REK nord
2017-001670-42 ( EudraCT Number )
First Posted: November 27, 2017    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hematoma, Subdural
Hematoma, Subdural, Chronic
Hematoma
Hemorrhage
Pathologic Processes
Intracranial Hemorrhage, Traumatic
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Craniocerebral Trauma
Trauma, Nervous System
Vascular Diseases
Cardiovascular Diseases
Wounds and Injuries
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants