Who is sponsoring NCT03353259?

NCT03353259 is sponsored by Oslo University Hospital.

What drugs are being tested in NCT03353259?

Interventions in NCT03353259: Tranexamic acid and Tocilizumab.

What condition does NCT03353259 study?

NCT03353259 studies Chronic Subdural Hematoma.

Is NCT03353259 still recruiting?

NCT03353259 is currently terminated. Last updated 13 October 2021.

Last reviewed 2021-10-13 · How we verify

NCT03353259

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Terminated Phase 2, PHASE3 Last updated 13 October 2021

What this trial tests

Phase 2, PHASE3 trial testing Tranexamic acid and Tocilizumab in Chronic Subdural Hematoma in 382 participants. Terminated before completion.

Timeline

28 November 2017

Primary endpoint
28 February 2021

1 September 2021

Quick facts

Lead sponsor	Oslo University Hospital
Phase	Phase 2, PHASE3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	382
Start date	28 November 2017
Primary completion	28 February 2021
Estimated completion	1 September 2021
Sites	1 location across Norway

Drugs / interventions tested

Tranexamic acid and Tocilizumab

Conditions studied

Chronic Subdural Hematoma — all drugs for Chronic Subdural Hematoma →

Sponsor

Oslo University Hospital

Who can join

Adults 55 to 100, any sex, with Chronic Subdural Hematoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Transfusion strategies in bleeding critically ill adults: a clinical practice guideline from the European Society of Intensive Care Medicine.
Vlaar APJ, Dionne JC, de Bruin S, Wijnberge M, et al · · 2021 · cited 65× · PMID 34677620 · DOI 10.1007/s00134-021-06531-x

Verify or expand the search:

Other recruiting trials for Chronic Subdural Hematoma

Currently open trials in the same condition.

NCT07245264 — Adjuvant Tranexamic Acid (TXA) Versus Surgery Alone for Adult Patients With Chronic Subdural Hematoma (CSDH) · Phase 2, PHASE3 · recruiting
NCT07144423 — Neuroendoscopy-assisted Drainage Versus Burr Hole Drainage for Chronic Subdural Hematoma · NA · recruiting
NCT07324551 — Microfabricated Microcatheter Advantages in Middle Meningeal Artery Embolization: an Early Experience at a Single Center · recruiting
NCT07421453 — Implementation of an Enhanced Recovery Pathway for Burr-hole Drainage in Patients With a Chronic Subdural Hematoma · recruiting
NCT06772740 — Middle Meningeal Artery Embolization for Patients With Chronic Subdural Hematoma · NA · recruiting

Other Oslo University Hospital trials

Trials by the same sponsor.

NCT07463885 — Spontaneous vs Controlled Mechanical Ventilation in Acute Hypoxemic Respiratory Failure · NA · not yet recruiting
NCT07427719 — Retinopathy of Prematurity - Visual Function and Retinal Structure · not yet recruiting
NCT07403331 — Severe Chronic Neuropathic Pain: A Treatment Bundle, Using Spinal Cord Stimulation and Multidisciplinary Treatment, to R · NA · recruiting
NCT07449897 — Cholecystectomy With Intraoperative Management of Bile Duct Stones in Norway - the BILNOR Study · recruiting
NCT06173817 — The Use of Isocapnic Hyperventilation (iHV) for Treatment of Methanol Poisoned Patients · Phase 1 · withdrawn

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03353259 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Oslo University Hospital
Last refreshed: 13 October 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03353259.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing