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

Primary Purpose

Chronic Subdural Hematoma

Status

Terminated

Phase

Phase 2

Locations

Norway

Study Type

Interventional

Intervention

Tranexamic acid and Tocilizumab

About this trial

This is an interventional treatment trial for Chronic Subdural Hematoma

Eligibility Criteria

55 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Milo Stanisic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Arm Label

SS-TG

SS-TXA-TG

SS-TXA-RoA

Arm Description

Standard surgery using burr-hole procedure, irrigation and drainage.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03353259

First Posted

October 17, 2017

Last Updated

October 5, 2021

Sponsor

Oslo University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03353259

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Terminated

Why Stopped

DMC concluded that the results of 382 included patients were clear.

Study Start Date

November 28, 2017 (Actual)

Primary Completion Date

February 28, 2021 (Actual)

Study Completion Date

September 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Oslo University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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: effectively decrease the rate of lesion recurrence requiring re-operation, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Subdural Hematoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

382 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SS-TG

Arm Type

No Intervention

Arm Description

Standard surgery using burr-hole procedure, irrigation and drainage.

Arm Title

SS-TXA-TG

Arm Type

Active Comparator

Arm Description

Arm Title

SS-TXA-RoA

Arm Type

Active Comparator

Arm Description

Intervention Type

Combination Product

Intervention Name(s)

Tranexamic acid and Tocilizumab

Other Intervention Name(s)

Cyklokapron and RoActemra

Intervention Description

The first intervention is Tranexamic acid, The second intervention is Tocilizumab

Primary Outcome Measure Information:

Title

Efficacy of Tocilizumab (RoActemra) and Tranexamic acid (Cyklokapron) used as Adjuncts to Chronic Subdural Hematoma Surgery Regarding Postoperative Recurrence

Description

To determine the rate in number and percentage of postoperative recurrence requiring re-operation

Time Frame

6 months period after the initial surgery.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Milo Stanisic

Organizational Affiliation

Oslo University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Milo Stanisic

City

Oslo

ZIP/Postal Code

0424

Country

Norway

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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