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

NCT03353259 | Terminated Phase 2 DMC

• 2 other identifiers: 2016/1512/REK nord2017-001670-42
• Study Type: interventional
• Target: 382
• Locations: 1 country
• Sites: 1

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. 1.effectively decrease the rate of lesion recurrence requiring re-operation,
2. 2.effectively shorten the time of lesion resolution.

Conditions

Chronic Subdural Hematoma

Outcome Measures

Primary Outcomes (1)

• 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

  6 months period after the initial surgery.

Study Arms (3)

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.

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.

Combination Product: Tranexamic acid and Tocilizumab

Interventions

Tranexamic acid and Tocilizumab COMBINATION_PRODUCT

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

Also known as: Cyklokapron and RoActemra

SS-TXA-RoA; SS-TXA-TG

Eligibility Criteria

• Age: 55 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with informed consent, without presenting of any known contraindication for the use of Tranexamic acid and Tocilizumab.

You may not qualify if:

• patients or relatives who refused to consent, presenting of any known contraindication for the use of Tranexamic acid and Tocilizumab.

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Milo Stanisic

Oslo, 0424, Norway

Location

MeSH Terms

Conditions

Hematoma, Subdural, Chronic

Interventions

Tranexamic Acid; tocilizumab

Condition Hierarchy (Ancestors)

Hematoma, Subdural; Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematoma; Hemorrhage; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Milo Stanisic

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 17, 2017
• First Posted: November 27, 2017
• Study Start: November 28, 2017
• Primary Completion: February 28, 2021
• Study Completion: September 1, 2021
• Last Updated: October 13, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)