Tranexamic Acid in the Treatment of Residual Chronic Subdural Hematoma

NCT03280212 | Unknown Phase 3 DMC

• 1 other identifier: 14-0176-GAP
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Subdural Hematoma

Keywords

Chronic subdural hematoma; Tranexamic acid; TXA

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Neurological outcome

  4-8 weeks, 8-12 weeks

• Quality of life

  4-8 weeks, 8-12 weeks

• Quality of life

  4-8 weeks, 8-12 weeks

• Occurrence of adverse events

  4-8 weeks, 8-12 weeks

Study Arms (2)

Tranexamic Acid Arm

EXPERIMENTAL

Tranexamic Acid 500 milligrams (MG) Participants of the Tranexamic Acid (TXA) arm will receive the study drug, TXA. Participants of average body weight (60-100kg) will receive TXA according to a 500mg three times daily (TID) dose regimen. Weight deviations from this range will see dose adjustments as follows: participants \<60kg will receive 500mg two times daily (BID), and participants \>100kg will receive 1000mg BID.

Drug: Tranexamic Acid 500 MG

Control Arm

NO INTERVENTION

No intervention Participants in the control arm will not receive any additional intervention, medication, or placebo, and will serve as a comparative arm for the experimental arm.

Interventions

Tranexamic Acid 500 MG DRUG

Tranexamic Acid 500mg oral tablets.

Also known as: TXA

Tranexamic Acid Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

RECRUITING

MeSH Terms

Conditions

Hematoma, Subdural, Chronic

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Hematoma, Subdural; Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematoma; Hemorrhage; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Central Study Contacts

Adriana M Workewych, HBSc

CONTACT

416-864-5312; workewycha@smh.ca

Stanley Zhang

CONTACT

416-864-5312; zhangsh@smh.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurosurgeon

Study Record Dates

• First Submitted: September 10, 2017
• First Posted: September 12, 2017
• Study Start: March 6, 2017
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: September 14, 2017

Record last verified: 2017-09

Locations

CA (1)