Authorised Phase III and phase IV (Integrated) Chronic Subdural Hematoma

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

EU CTIS ID: 2024-514927-40-02

What this study is testing

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.

  • Phase III and phase IV (Integrated)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • 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).

You likely can't join if

  • 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;

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.