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Compares treatment options for Chronic Subdural Hematoma
Official title Adjuvant Tranexamic Acid (TXA) Versus Surgery Alone for Adult Patients With Chronic Subdural Hematoma (CSDH)
ClinicalTrials.gov ID: NCT07245264
What this study is testing
What is Tranexamic Acid (Cyklokapron)?
Tranexamic Acid (Cyklokapron) is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for chronic subdural hematoma.
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
- This study is an open label randomized controlled trial. Patients with a symptomatic Chronic Subdural Hematoma (CSDH) confirmed on radiological imaging, planned for surgery, age over 18, free from other intracranial pathologies and no previous intracranial surgery, will be recruited at time of admission.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Symptomatic chronic subdural hematoma confirmed on computer tomography (CT) or magnetic resonance imaging (MRI) measuring greater than 10 mm...
- Adult patient ≥18 years
- Scheduled for single or double burr hole for evacuation.
- No contraindication for TXA
You likely can't join if
- Mechanical heart valve
- Newly diagnosed (last 12 months) pulmonary embolism, myocardial infarction, and strong indication for antithrombotic treatment
- Intracranial surgery within last 6 months
- Pregnancy and woman\<40 years
- Participation in any other clinical trial
- Life expectancy of less than one year.
See the full eligibility criteria
- Symptomatic chronic subdural hematoma confirmed on computer tomography (CT) or magnetic resonance imaging (MRI) measuring greater than 10 mm thickness.
- Adult patient ≥18 years
- Scheduled for single or double burr hole for evacuation.
- No contraindication for TXA
- Mechanical heart valve
- Newly diagnosed (last 12 months) pulmonary embolism, myocardial infarction, and strong indication for antithrombotic treatment
- Intracranial surgery within last 6 months
- Pregnancy and woman\<40 years
- Participation in any other clinical trial
- Life expectancy of less than one year.
- A score on the modified Rankin scale, designed to assess functional independence, of 4 or 5 (scores range from 0 [no symptoms] to 6 [death]) before the hematoma occurred.
- Unfit for participations for any other reason as evaluated by the including physician.
- History of severe impairment of renal function (eGFR \ 150μmol/L)
- Known hypersensitivity or allergy to TXA
- Inability to obtain informed consent from the patient or legal representative
The study team makes the final eligibility decision.
Where it's taking place
- Chandigarh, India
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chandigarh, India. 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.