Chronic Subdural HematomaPhase 2/3NCT03353259
Tocilizumab (RoActemra) and Tranexamic Acid (Cyklokapron) Used as Adjuncts to Chronic Subdural Hematoma Surgery
A Phase 2/3 study testing Tranexamic acid and Tocilizumab in people with Chronic Subdural Hematoma, run by Oslo University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 100 years
- Conditions the study is for
- Chronic Subdural Hematoma
- What is being tested?
- Tranexamic acid and Tocilizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 382 participants
- Where
- 1 siteNorway
- Study dates
- 28 Nov 2017to 1 Sep 2021
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with informed consent, without presenting of any known contraindication for the use of Tranexamic acid and Tocilizumab.
Who cannot join
- patients or relatives who refused to consent, presenting of any known contraindication for the use of Tranexamic acid and Tocilizumab.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Chronic Subdural Hematoma
- Being tested
- Tranexamic acid and Tocilizumab
- Medical subject headings
- Hematoma, Subdural, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acid and TocilizumabCombination product
Also called Cyklokapron and RoActemra
The first intervention is Tranexamic acid, The second intervention is Tocilizumab
| Study group | Role | What they receive |
|---|---|---|
| SS-TG | No intervention | Standard surgery using burr-hole procedure, irrigation and drainage. |
| SS-TXA-TG | Active comparator | 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. Receives: Combination Product: Tranexamic acid and Tocilizumab |
| SS-TXA-RoA | Active comparator | 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. Receives: Combination Product: Tranexamic acid and Tocilizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months period after the initial surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2017
- Study start28 Nov 2017
- Primary completion28 Feb 2021
- Study completion1 Sep 2021
Why it stopped: DMC concluded that the results of 382 included patients were clear.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Subdural HematomaStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 382 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Milo Stanisic, Oslo University Hospital
- Investigators
- Milo Stanisic, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03353259
- Sponsor's protocol ID
- 2016/1512/REK nord
- Other IDs
- 2017-001670-42, 2017
- Status last verified
- Sep 2021
- First submitted
- 17 Oct 2017
- Last updated
- 13 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ivanovic J, Ronning PA, Lashkarivand A, Mendoza EEM, Stanisic M. Tranexamic Acid and Tocilizumab as Adjuvant Therapy to Chronic Subdural Hematoma Surgery: A Randomized Controlled Trial. Neurosurgery. 2026 Jul 9. doi: 10.1227/neu.0000000000004157. Online ahead of print.
PubMed 42423601
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tocilizumab (RoActemra) and Tranexamic Acid (Cyklokapron) Used as Adjuncts to Chronic Subdural Hematoma Surgery
- ClinicalTrials.gov ID
- NCT03353259
- Acronym / sponsor ID
- 2016/1512/REK nord
- Conditions
- Chronic Subdural Hematoma
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: DMC concluded that the results of 382 included patients were clear.
- Enrolment
- 382 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 28 Nov 2017 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 27 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SS-TG | No intervention | –Standard surgery using burr-hole procedure, irrigation and drainage. |
| SS-TXA-TG | Active comparator | Combination Product: Tranexamic acid and TocilizumabStandard 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. |
| SS-TXA-RoA | Active comparator | Combination Product: Tranexamic acid and TocilizumabStandard 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. |
Who may qualify
- Ages
- 55 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with informed consent, without presenting of any known contraindication for the use of Tranexamic acid and Tocilizumab.
Key exclusion criteria (1 listed)
- patients or relatives who refused to consent, presenting of any known contraindication for the use of Tranexamic acid and Tocilizumab.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic acid and TocilizumabAlso: Cyklokapron and RoActemraThe first intervention is Tranexamic acid, The second intervention is Tocilizumab | Combination product | SS-TXA-RoA, SS-TXA-TG |
Primary outcome
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
Results and safety
The study was stopped early (reason given: DMC concluded that the results of 382 included patients were clear.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2021.
- Derived from this study: PubMed 42423601Ivanovic J, Ronning PA, Lashkarivand A, Mendoza EEM, Stanisic M. Tranexamic Acid and Tocilizumab as Adjuvant Therapy to Chronic Subdural Hematoma Surgery: A Randomized Controlled Trial. Neurosurgery. 2026 Jul 9. doi: 10.1227/neu.0000000000004157. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Milo Stanisic principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Tranexamic acid and Tocilizumab in people with Chronic Subdural Hematoma, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: DMC concluded that the results of 382 included patients were clear.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03353259, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2021.