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

Sponsor
Oslo University Hospital
Study ID
NCT03353259
Phase
PHASE2/PHASE3
Status
Terminated

Conditions

  • Chronic Subdural Hematoma

Eligibility Criteria

Sex
ALL
Age
55 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Nov 28, 2017
Status verified
Sep 2021
Primary completion
Feb 28, 2021
Completion
Sep 1, 2021

Study Design

Enrollment
382 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

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. ]

Related Studies