- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03353259
Tocilizumab (RoActemra) and Tranexamic Acid (Cyklokapron) Used as Adjuncts to Chronic Subdural Hematoma Surgery
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.
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Oslo, Norway, 0424
- Milo Stanisic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
The first intervention is Tranexamic acid, The second intervention is Tocilizumab
Other Names:
|
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.
|
The first intervention is Tranexamic acid, The second intervention is Tocilizumab
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
6 months period after the initial surgery.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Milo Stanisic, Oslo University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Wounds and Injuries
- Hemorrhage
- Craniocerebral Trauma
- Trauma, Nervous System
- Intracranial Hemorrhages
- Intracranial Hemorrhage, Traumatic
- Hematoma
- Hematoma, Subdural
- Hematoma, Subdural, Chronic
- Molecular Mechanisms of Pharmacological Action
- Fibrin Modulating Agents
- Antifibrinolytic Agents
- Hemostatics
- Coagulants
- Tranexamic Acid
Other Study ID Numbers
- 2016/1512/REK nord
- 2017-001670-42 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Subdural Hematoma
-
Ospedale Policlinico San MartinoNot yet recruitingEndovascular vs Conservative Treatment in Patients With Chronic Subdural Hematomas and Mild SymptomsSubdural Hematoma, Chronic
-
University Hospital, MontpellierHospices Civils de Lyon; Centre Hospitalier Universitaire de Nice; University... and other collaboratorsTerminatedChronic Intracranial Subdural HematomaFrance
-
Ataturk Training and Research HospitalCompletedSubdural Hematoma, ChronicTurkey
-
Balt USAAXIOM Real Time Metrics; Embo-Flüssigkeiten A.G.; Balt ExtrusionActive, not recruitingSubdural Hematoma, ChronicUnited States, France, Germany, Spain
-
Rennes University HospitalCompleted
-
Academisch Medisch Centrum - Universiteit van Amsterdam...RecruitingChronic Subdural HematomasNetherlands
-
The University of Texas Medical Branch, GalvestonNational Institute of Neurological Disorders and Stroke (NINDS)Not yet recruitingChronic Subdural HematomaUnited States
-
Chinese University of Hong KongWithdrawnChronic Subdural Hematoma | Subdural HematomaChina
-
University Hospital, GenevaNot yet recruitingChronic Subdural Hematomas | Cerebral Compression Due to Injury
-
Kwong Wah HospitalUnknownChronic Subdural Hematoma | Subdural DrainChina
Clinical Trials on Tranexamic acid and Tocilizumab
-
Icahn School of Medicine at Mount SinaiRecruiting
-
University of LiegeCompletedArthroplasty Complications | Hemorrhage Postoperative | Total Blood LossBelgium
-
Samsung Medical CenterUnknownBleeding | Transfusion Related ComplicationKorea, Republic of
-
London School of Hygiene and Tropical MedicineCompleted
-
Ain Shams UniversityCompleted
-
Aswan University HospitalCompletedCesarean Section ComplicationsEgypt
-
Thammasat UniversityCompleted
-
Ferring PharmaceuticalsCompleted
-
Assiut UniversityCompleted
-
London School of Hygiene and Tropical MedicineRawalpindi Medical CollegeCompletedPregnancy, High RiskPakistan, Zambia