Tranexamic Acid in the Treatment of Residual Chronic Subdural Hematoma

Chronic Subdural Hematoma Clinical Trial

— TRACE  

Official title:

Tranexamic Acid in the Treatment of Residual Chronic Subdural Hematoma: A Single-centre, Observer-blinded, Randomized Controlled Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03280212
• Other study ID #: 14-0176-GAP
• Status: Recruiting
• Phase: Phase 3
• First received: September 10, 2017
• Last updated: September 13, 2017
• Start date: March 6, 2017
• Est. completion date: March 2018

Study information

• Verified date: September 2017
• Source: St. Michael's Hospital, Toronto
• Contact: Adriana M Workewych, HBSc
• Phone: 416-864-5312
• Email: workewycha[@]smh.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Chronic subdural hematoma (CSDH) is a common disease after minor head trauma, especially in elderly patients. This medical condition is characterized by blood collection in the subdural space, which can result in severe neurological impairment. Current standard of care is the evacuation of the CSDH by means of different surgical approaches. Although clinical and surgical outcomes are satisfying in most cases, considerable morbidity and mortality as well as recurrence rates of 3-31% are frequently reported. Therefore a non-surgical approach for the treatment of CSDH would be desirable. Tranexamic acid (TXA), an antifibrinolytic drug has been shown to decrease hematoma volume in a small cohort of patients suffering from CSDH. The present study is designed to test the hypothesis that TXA can reduce the volume of CSDH. Volume measurements of residual CSDH after burr-hole surgery will be performed during study course to quantify treatment success. The trial is designed as a randomized controlled pilot study, where half of the patients will be assigned to daily intake of TXA, whereas the other half will receive medical treatment according to current practice without TXA prescription. The primary endpoint of the study is defined as volume change in milliliters (mL) after 4-8 weeks of treatment. Secondary endpoints are hematoma volume change at 8-12 weeks, the rate of patients with resolution of the CSDH after 4-8 weeks and 8-12 weeks days, as well as the rate of reoperation during study course due to hematoma extension and neurological deterioration. Additionally the neurological outcome and the drug compatibility will be estimated as secondary objectives.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients diagnosed with chronic subdural hematoma, and have a planned or have received a unilateral or bilateral burr-hole craniostomy or mini-craniotomy

• Written informed consent (patient, power of attorney or substitute decision maker)

• Competence to take study medication properly and regularly or access to care giver that is able to comply with accurate study medication administration

Exclusion Criteria:

• Hypersensitivity to TXA or any of the ingredients

• Pregnancy

• Irregular menstrual bleeding with unidentified cause

• Acquired colour vision disturbances

• Acute and chronic renal insufficiency indicated by glomerular filtration rate (GFR) = 30 mL/min

• Hematuria, caused by diseases of renal parenchyma

• Current alcohol abuse (as indicated by an Alcohol Use Disorders Identification Test (AUDIT) score of 10 or higher) drug abuse, or recreational drug use

• Concomitant intake of hormonal contraceptives, factor IX complex concentrates, and anti-inhibitor coagulant concentrates (factor VII, activated factor IX)

• Active, history, or increased risk of thrombotic events (including deep vein thrombosis, pulmonary embolism, cerebral venous thrombosis, arterial thrombotic events), symptomatic carotid stenosis, myocardial infarction, acute coronary syndrome, coronary artery disease, or consumption coagulopathy within the past 2 years

• History of angioplasty with cardiac stent placement or mechanical heart valve

• Active or history of brain pathologies such as stroke (hemorrhagic and ischemic), subarachnoid hemorrhage, or malignant brain tumors (glioma, metastasis and others) as well as history of seizures within the past 2 years

• Contraindication to stopping full therapeutic doses of non-acetylsalicylic acid (ASA) antiplatelets, warfarin, rivaroxaban, apixaban, dabigatran, or other anticoagulant for 2 weeks after surgery

• Patients requiring immediate revision surgery (as defined by attending surgeon)

• Inability of oral drug intake or missing support to guarantee oral drug intake

Related Conditions & MeSH terms

• Chronic Subdural Hematoma
• Hematoma
• Hematoma, Subdural, Chronic

Intervention

Drug:
• Tranexamic Acid 500 MG
Tranexamic Acid 500mg oral tablets.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chronic subdural hematoma volume change	Change in hematoma volume in mL according to volume measurements made on CT scans comparing CT scan at 4-8 weeks to immediate post-operative CT scan.	4-8 weeks, 8-12 weeks
Secondary	Neurological outcome	An assessment of neurological outcome as measured by the National Institutes of Health Stroke Scale (NIHSS)	4-8 weeks, 8-12 weeks
Secondary	Quality of life	Participants quality of life as measured on the Health Utilities Index (HUI).	4-8 weeks, 8-12 weeks
Secondary	Quality of life	Participants quality of life as measured on the 36-item Short Form Health Survey (SF-36).	4-8 weeks, 8-12 weeks
Secondary	Occurrence of adverse events	Safety of the TXA dose regimen by monitoring incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	4-8 weeks, 8-12 weeks