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New treatment option for Hematoma, Subdural, Chronic
Official title Tranexamic Acid to Prevent OpeRation in Chronic Subdural Hematoma
ClinicalTrials.gov ID: NCT03582293
What this study is testing
What is Tranexamic Acid 500Mg Tablet?
Tranexamic Acid 500Mg Tablet is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for hematoma, subdural, chronic.
Also referred to as Cyklokapron.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Rationale: Chronic subdural hematoma (cSDH) is a frequently occurring disease, occurring mainly in the elderly. Surgical evacuation is effective, but also associated with life-threatening risks.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
You may be able to join if
- On CT confirmed cSDH
- Primary conservative treatment, based on clinical symptoms: Glasgow Coma Scale score \>=14, mNIHSS score \<=4 and a stable neurological deficit (no...
You likely can't join if
- Primary surgical treatment based on one or more of the following symptoms or parameters: medically intractable headache, midline shift \>10mm...
- 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;
See the full eligibility criteria
- On CT confirmed cSDH
- 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...
- Primary surgical treatment based on one or more of the following symptoms or parameters: medically intractable headache, midline shift \>10mm, 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 (eGFR \ 150μmol/L);
- History of anaemia (haemoglobin \<6mmol/L);
- History of convulsions;
- 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.
Where it's taking place
- Amsterdam, Netherlands
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amsterdam, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.