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New treatment option for Subdural Hematoma
Official title The Use of Tranexamic Acid in the Treatment of Symptomatic Subdural Hematoma
ClinicalTrials.gov ID: NCT05713630
What this study is testing
What is Tranexamic acid (TXA)?
Tranexamic acid (TXA) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for subdural hematoma.
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
- Subdural hematoma (SDH) is a common condition experienced after head injury. Blood collects on the surface of the brain, causing headaches which can progress to confusion, weakness, or even coma.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 and older
You may be able to join if
- Patients aged 45 and older weighing between 45-150 kg diagnosed with symptomatic SDH will be included. SDH is defined as unilateral or bilateral...
You likely can't join if
- \- Patients will be excluded for any of the following conditions:
- Asymptomatic for longer than 72 hours
- SDH less than 8 mm in maximal thickness
- Have an acutely deteriorating neurological status (e.g., brain herniation with pupillary dilation, aneurysm rupture, etc.) that is likely to be fatal...
- Presence of brain contusion larger than 5 cubic centimeters or subarachnoid hemorrhage (SAH) thicker than 10 mm with Glasgow Coma Scale (GCS)\< 13
- Patients with primarily interhemispheric or tentorial SDH
See the full eligibility criteria
- Patients aged 45 and older weighing between 45-150 kg diagnosed with symptomatic SDH will be included. SDH is defined as unilateral or bilateral crescentic collection of blood (hyper, iso, or hypodense, or mixed...
- \- Patients will be excluded for any of the following conditions:
- Asymptomatic for longer than 72 hours
- SDH less than 8 mm in maximal thickness
- Have an acutely deteriorating neurological status (e.g., brain herniation with pupillary dilation, aneurysm rupture, etc.) that is likely to be fatal within 6 hours or less due to a predominantly acute SDH
- Presence of brain contusion larger than 5 cubic centimeters or subarachnoid hemorrhage (SAH) thicker than 10 mm with Glasgow Coma Scale (GCS)\< 13
- Patients with primarily interhemispheric or tentorial SDH
- Hypersensitivity to TXA or any of the placebo ingredients
- Pregnancy
- Irregular menstrual bleeding with unidentified cause
- Known acquired colour vision disturbances
- Hematuria caused by renal parenchymal disease
- Acute and chronic renal insufficiency indicated by estimated Glomerular Filtration Rate (eGFR) ≤ 30 mL/min
- Concomitant intake of birth control pill and/or hormonal replacement therapy, and anti-inhibitor coagulant concentrates (factor VIII inhibitor bypass activity (FEIBA), factor VII, activated factor IX)
- Consumption coagulopathy/disseminated intravascular coagulation (DIC) in the last 7 days
- Not competent to take study medication properly and regularly or not having access to caregiver that is able to comply with study medication administration
- Mechanical heart valve
- Liver cirrhosis
- Recent venous and/or arterial thromboembolism within 6 months of study enrolment
- SDH caused by intracranial hypotension
- Known thrombophilia (e.g., antiphospholipid syndrome)
- Any active malignancy: metastatic cancer systemically or to the brain or a primary malignant brain tumour treated within the last 6 months
- Previous enrolment in this trial for a prior episode
- Time interval \>3 days from the time of clinical assessment to eligibility assessment
- Patients weighing \ 150 kg
- Patients received any amount of TXA upon admittance to hospital prior to enrolment
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
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, 45 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. 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.