The Use of Tranexamic Acid in the Treatment of Symptomatic Subdural Hematoma

Phase 3Not Yet RecruitingNCT05713630

Unity Health Toronto130 enrolled

Overview

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. While patients with SDH often receive surgery, not all patients require surgery right away to ease pressure on the brain. After surgery, there can be up to 30 percent chance of more bleeding and the need for more surgeries. Given this, a drug capable of lowering the chance of more bleeding and speeding the recovery of the patient is highly desirable. In this study, we will test a commonly used, cheap drug called Tranexamic Acid (TXA). While the body stops unwanted and sometimes dangerous bleeding naturally by forming blood clots, TXA stops these blood clots from breaking down, which helps to keep bleeding spots plugged. Our previous study showed that TXA helped speed up patients' recovery; but a larger number of patients is necessary to evaluate how well TXA works to reduce bleeding and improve patient-reported outcomes. In this study, regardless of the need for surgery, half of the patients will be randomly assigned to take TXA, while the other half will take a placebo, which is a look-alike substance that contains no active drug. We will measure multiple outcomes over time to determine if TXA is working and lowers healthcare and personal costs, while also taking blood and surgical samples, to better understand how this drug works in SDH patients.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

130

Conditions

Subdural Hematoma

Eligibility

Sex: ALLMin age: 45 Years

Medical Language ↔ Plain English

Inclusion 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 density) of greater than or equals to 8 mm in thickness along the cerebral convexity on CT of the head. Symptomatic SDH patients eligible for inclusion are those with SDH with one or more of the following symptoms attributable to the SDH: headache, gait disturbance, confusion or cognitive decline, limb weakness or numbness/paresthesia, speech or visual disturbance, drowsiness or impaired consciousness, seizures, impaired cognition, or memory loss at the time of assessment. Exclusion Criteria: \- Patients will be excluded for any of the following conditions: 1. Asymptomatic for longer than 72 hours 2. SDH less than 8 mm in maximal thickness 3. 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 4. Presence of brain contusion larger than 5 cubic centimeters or subarachnoid hemorrhage (SAH) thicker than 10 mm with Glasgow Coma Scale (GCS)\< 13 5. Patients with primarily interhemispheric or tentorial SDH 6. Hypersensitivity to TXA or any of the placebo ingredients 7. Pregnancy 8. Irregular menstrual bleeding with unidentified cause 9. Known acquired colour vision disturbances 10. Hematuria caused by renal parenchymal disease 11. Acute and chronic renal insufficiency indicated by estimated Glomerular Filtration Rate (eGFR) ≤ 30 mL/min 12. 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) 13. Consumption coagulopathy/disseminated intravascular coagulation (DIC) in the last 7 days 14. Not competent to take study medication properly and regularly or not having access to caregiver that is able to comply with study medication administration 15. Mechanical heart valve 16. Liver cirrhosis 17. Recent venous and/or arterial thromboembolism within 6 months of study enrolment 18. SDH caused by intracranial hypotension 19. Known thrombophilia (e.g., antiphospholipid syndrome) 20. Any active malignancy: metastatic cancer systemically or to the brain or a primary malignant brain tumour treated within the last 6 months 21. Previous enrolment in this trial for a prior episode 22. Time interval \>3 days from the time of clinical assessment to eligibility assessment 23. Patients weighing \<45 kg or \>150 kg

Outcomes

Primary Outcomes

European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L)

A self-rated questionnaire that assesses a patient's health state in five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.

Time frame: Every 2 weeks after randomization up to 45±10 days.

Secondary Outcomes

Patient-Reported Outcomes Measurement Information System (PROMIS) Scale v1.2 - Global Health. English and French versions

A 10-item measure that assesses an individual's general physical, mental, and social health as it is intended to globally reflect individuals' assessment of their physical and mental health in the last 7 days.

Time frame: Baseline and every 2 weeks after randomization up to 45±10 days, and then at 60-90 days, and 180±10 days after randomization.

PROMIS Item Bank v2.0 - Cognitive Function. English version

A measure that assesses cognitive function that will be administered as a computer adaptive test.

Time frame: Baseline and every 2 weeks after randomization up to 45±10 days, and then at 60-90 days, and 180±10 days after randomization.

PROMIS Item Bank v2.0 - Physical Function. English version

A measure that assesses self-reported capability rather than actual performance of physical activities that will be administered as a computer adaptive test.

Time frame: Baseline and every 2 weeks after randomization up to 45±10 days, and then at 60-90 days, and 180±10 days after randomization.

PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities. English version

A measure that assesses the perceived ability to perform one's usual social roles and activities that will be administered as a computer adaptive test. The item bank does not use a time frame (e.g. over the past 7 days) when assessing ability to participate in social roles and activities.

Time frame: Baseline and every 2 weeks after randomization up to 45±10 days, and then at 60-90 days, and 180±10 days after randomization.

Subdural hematoma volume change

Change in hematoma volume in millilitres on CT scan.

Time frame: Baseline, 45±10 days after randomization, and 60-90 days if deemed necessary for the patient's routine care.

Number of subdural hematoma-related surgical interventions

Time frame: First admission, subsequent admissions up to 180 days after randomization

Recurrence rate of SDH

Time frame: 45±10 days, 60-90 days, and 180±10 days after randomization

Mortality

Time frame: During the course of study up to 180±10 days after randomization

Modified Rankin Scale

A 6-point disability scale used to measure the degree of disability in patients who have had a stroke.

Time frame: Baseline, 45±10 days, 60-90 days, and 180±10 days after randomization

Disability Rating Scale

Eight questions regarding body function, activity, participation, communication, and movements each rated on a 3-5-point scale that is summed to give a total score.

Time frame: Baseline, 45±10 days, 60-90 days, and 180±10 days after randomization

Montreal Cognitive Assessment

This assessment evaluates the patient's cognition based on eight areas: visuospatial/executive function, naming, memory, attention, language, abstraction, delayed recall, and orientation.

Time frame: Baseline, 45±10 days, and 60-90 days after randomization

Medical Consumption Questionnaire

Health-related cost questionnaire on the use of healthcare in the past month.

Time frame: Baseline, 45±10 days, and 180±10 days after randomization

EQ-5D-5L

A self-rated questionnaire that assesses a patient's health state in five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.

Time frame: Baseline, 60-90 days, and 180±10 days after randomization

Adverse events

Adverse events of grade 3 or higher as defined by Good Clinical Practice Guidelines.

Time frame: Discharge, 45±10 days, 60-90 days, and 180±10 days after randomization

Length of stay in hospital due to subdural hematoma

Time frame: During the course of the study up to 180±10 days after randomization

Disposition after discharged from hospital

Time frame: During the course of the study up to 180±10 days after randomization

The Use of Tranexamic Acid in the Treatment of Symptomatic Subdural Hematoma

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts