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

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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

Tracking Information
First Submitted Date  ICMJE October 17, 2017
First Posted Date  ICMJE November 27, 2017
Last Update Posted Date May 27, 2020
Actual Study Start Date  ICMJE November 28, 2017
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 22, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tocilizumab (RoActemra) and Tranexamic Acid (Cyklokapron) Used as Adjuncts to Chronic Subdural Hematoma Surgery
Official Title  ICMJE Tocilizumab (RoActemra) and Tranexamic Acid (Cyklokapron) Used as Adjuncts to Chronic Subdural Hematoma Surgery
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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Subdural Hematoma
Intervention  ICMJE Combination Product: Tranexamic acid and Tocilizumab
The first intervention is Tranexamic acid, The second intervention is Tocilizumab
Other Name: Cyklokapron and RoActemra
Study Arms  ICMJE
  • 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.
    Intervention: Combination Product: Tranexamic acid and Tocilizumab
  • 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.
    Intervention: Combination Product: Tranexamic acid and Tocilizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 22, 2017)
600
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2022
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Milo Stanisic, DrMedSci +47 93932382 mstanisi@ous-hf.no
Contact: Milo Stanisic +47 93932382 mstanisi@ous-hf.no
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03353259
Other Study ID Numbers  ICMJE 2016/1512/REK nord
2017-001670-42 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Milo Stanisic, Oslo University Hospital
Study Sponsor  ICMJE Oslo University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Milo Stanisic Oslo University Hospital
PRS Account Oslo University Hospital
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP