Tranexamic acid to prevent OpeRation in Chronic subdural Hematoma (TORCH)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Stichting Amsterdam UMC

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

1 Oct 2024 → ongoing

Decision date (initial)

2024-09-23

Transition trial

Yes

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

External identifiers

EU CT number

2024-514927-40-02

EudraCT number

2017-004311-40

ClinicalTrials.gov

NCT03582293

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To assess whether patients with chronic subdural hematoma (cSDH) who receive primary conservative treatment with TXA need to undergo surgery for cSDH within 12 weeks after treatment initiation less often compared to those receiving a placebo.

Conditions and MedDRA coding

Chronic Subdural Hematoma

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. In order to be eligible to participate in this study, a subject must meet all of the following criteria: • Age 50 years and above; • On CT confirmed cSDH, performed 14 days before inclusion at the latest (for definition, see paragraph 4.1); • Primary conservative treatment, based on clinical symptoms: Glasgow Coma Scale score >=14, mNIHSS score <=4 and a stable neurological deficit (no new, or progression of, symptoms between the assessment by the neurologist and the assessment by the neurosurgeon).

Exclusion criteria 1

1. potential subject who meets any of the following criteria is excluded from participation in this study: • Primary surgical treatment based on one or more of the following symptoms or parameters: medically intractable headache, midline shift >10mm (if >5mm, then judgement of second independent neurosurgeon is required), imminent death within 24 hours; • Structural causes for subdural haemorrhage, e.g. arachnoid cysts, cortical vascular malformations and a history of cranial surgery <1year; • Aneurysmal subarachnoid haemorrhage; • Active treatment for deep vein thrombosis, pulmonary embolism or cerebral thrombosis (secondary prophylaxis is not considered to be active treatment); • Active intravascular clotting or disseminated intravascular coagulation; • Known hypersensitivity or allergy to TXA or to any of the ingredients; • History of a blood coagulation disorder (hypercoagulability disorder); • History of severe impairment of renal function (serum creatinine >500μmol/L); • Anamnesis with signs of anaemia; • History of epilepsy; • History of inability to safely swallow oral medication. • Inability to obtain informed consent from the patient or legal representative (when the patient has a depressed level of consciousness as described in paragraph 11.2), including language barrier;

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Need to undergo surgery for chronic subdural hematoma within 12 weeks after TXA treatment initiation less often compared to those receiving a placebo

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Stichting Amsterdam UMC

Sponsor organisation

Stichting Amsterdam UMC

Address

De Boelelaan 1117

City

Amsterdam

Postcode

1081 HV

Country

Netherlands

Scientific contact point

Organisation

Stichting Amsterdam UMC

Contact name

Secretariaat Neurchirurgie

Public contact point

Organisation

Stichting Amsterdam UMC

Contact name

Secretariaat Neurchirurgie

Locations

1 EU/EEA country · 16 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 12 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications