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

NCT ID: NCT03353259

Last Updated: 2021-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

382 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-28

Study Completion Date

2021-09-01

Brief Summary

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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

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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.

Conditions

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Chronic Subdural Hematoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SS-TG

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type ACTIVE_COMPARATOR

Tranexamic acid and Tocilizumab

Intervention Type COMBINATION_PRODUCT

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

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.

Group Type ACTIVE_COMPARATOR

Tranexamic acid and Tocilizumab

Intervention Type COMBINATION_PRODUCT

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

Interventions

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Tranexamic acid and Tocilizumab

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

Intervention Type COMBINATION_PRODUCT

Other Intervention Names

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Cyklokapron and RoActemra

Eligibility Criteria

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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.
Minimum Eligible Age

55 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Milo Stanisic

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Milo Stanisic

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

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Milo Stanisic

Oslo, , Norway

Site Status

Countries

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Norway

Other Identifiers

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2017-001670-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2016/1512/REK nord

Identifier Type: -

Identifier Source: org_study_id