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NCT05713630 Clinical Trial

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

Subdural Hematoma Clinical Trial

— TRACE  

Official title:
TRACE STUDY: A Randomized Controlled Trial Using Tranexamic Acid in the Treatment of Subdural Hematoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05713630
Other study ID # 471164
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date July 2024
Est. completion date July 2026

Study information
Verified date May 2024
Source Unity Health Toronto
Contact Michael D Cusimano, MD, PhD
Phone 416-864-5312
Email injuryprevention@smh.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

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Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Tranexamic acid (TXA)
GD-Tranexamic Acid 500 mg oral tablet over-encapsulated to match the placebo. Sandoz-Tranexamic Acid 100 mg/mL solution for injection via intravenous (IV) added to a 100mL infusion bag of NaCl 0.9% and infused by slow intravenous injection over 20 minutes.
• Placebo
Placebo 500 mg consisting of an identical capsule to over-encapsulated tranexamic acid oral tablet entirely filled with microcrystalline cellulose, and sealed. Placebo 100 mg/mL solution for injection via intravenous (IV) consisting of 0.9% sodium chloride (saline).

Locations
Country Name City State
Canada St. Michael's Hospital Toronto Ontario

Sponsors (4)
Lead Sponsor Collaborator
Unity Health Toronto Applied Health Research Centre, Canadian Institutes of Health Research (CIHR), The Physicians' Services Incorporated Foundation

Country where clinical trial is conducted

Canada, 

References & Publications (68)

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Outcome
Type Measure Description Time frame Safety issue
Primary 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. Every 2 weeks after randomization up to 45±10 days.
Secondary 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. Baseline and every 2 weeks after randomization up to 45±10 days, and then at 60-90 days, and 180±10 days after randomization.
Secondary PROMIS Item Bank v2.0 - Cognitive Function. English version A measure that assesses cognitive function that will be administered as a computer adaptive test. Baseline and every 2 weeks after randomization up to 45±10 days, and then at 60-90 days, and 180±10 days after randomization.
Secondary 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. Baseline and every 2 weeks after randomization up to 45±10 days, and then at 60-90 days, and 180±10 days after randomization.
Secondary 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. Baseline and every 2 weeks after randomization up to 45±10 days, and then at 60-90 days, and 180±10 days after randomization.
Secondary Subdural hematoma volume change Change in hematoma volume in millilitres on CT scan. Baseline, 45±10 days after randomization, and 60-90 days if deemed necessary for the patient's routine care.
Secondary Number of subdural hematoma-related surgical interventions First admission, subsequent admissions up to 180 days after randomization
Secondary Recurrence rate of SDH 45±10 days, 60-90 days, and 180±10 days after randomization
Secondary Mortality During the course of study up to 180±10 days after randomization
Secondary Modified Rankin Scale A 6-point disability scale used to measure the degree of disability in patients who have had a stroke. Baseline, 45±10 days, 60-90 days, and 180±10 days after randomization
Secondary 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. Baseline, 45±10 days, 60-90 days, and 180±10 days after randomization
Secondary 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. Baseline, 45±10 days, and 60-90 days after randomization
Secondary Medical Consumption Questionnaire Health-related cost questionnaire on the use of healthcare in the past month. Baseline, 45±10 days, and 180±10 days after randomization
Secondary 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. Baseline, 60-90 days, and 180±10 days after randomization
Secondary Adverse events Adverse events of grade 3 or higher as defined by Good Clinical Practice Guidelines. Discharge, 45±10 days, 60-90 days, and 180±10 days after randomization
Secondary Length of stay in hospital due to subdural hematoma During the course of the study up to 180±10 days after randomization
Secondary Disposition after discharged from hospital During the course of the study up to 180±10 days after randomization
See also
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Terminated NCT05472766 - Anticoagulation Therapy Timing in Atrial Fibrillation After Acute and Chronic Subdural Hematoma N/A
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Completed NCT02368366 - Comparative Effectiveness of Family Problem-Solving Therapy (F-PST) for Adolescent TBI N/A
Terminated NCT01463878 - Enteral Nutrition and Glycemic Variability Neurological Intensive Care Unit Study Phase 4
Not yet recruiting NCT06119932 - Evaluation of One Burr Hole Evacuation for Subdural Hematoma
Completed NCT02618382 - A Study on the Safety of Tranexamic Acid for the Chronic Subdural Hematoma Population Phase 4
Recruiting NCT04923984 - Embolization of Middle Meningeal Artery for Subdural Hematoma in Canada (EMMA Can) N/A
Completed NCT03153150 - Start or STop Anticoagulants Randomised Trial (SoSTART) Phase 3
Completed NCT04270955 - Dartmouth Middle Meningeal Embolization Trial (DaMMET) N/A
Recruiting NCT06067750 - Comparison of Narcotrend and Cerebral Function Analysing Monitor in Intensive Care to Monitor Seizures and Deep Sedation
Withdrawn NCT01605357 - Hypernatremia for the Prevention and Treatment of Cerebral Edema in Traumatic Brain Injury Phase 1/Phase 2
Withdrawn NCT04500795 - Prospective Study on the Use of Middle Meningeal Artery Embolization for Chronic Subdural Haematoma N/A
Recruiting NCT04170582 - Patient Registry for Patients With Chronic Subdural Hematoma
Recruiting NCT05649904 - AFFECT Study for Patients With Intraventricular Hemorrhage, Subarachnoid Hemorrhage, Subdural Hematoma, and Ventriculitis N/A
Recruiting NCT04211233 - Diagnostic Subdural EEG-electrode And Subdural hEmatoma (DISEASE) N/A

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