Tranexamic Acid in the Treatment of Residual Chronic Subdural Hematoma -2

NCT04898712 | Unknown Phase 2 DMC

• 1 other identifier: 17-232
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic subdural hematoma (CSDH), a common disease after minor head trauma, is characterized by blood collection in the subdural space, which can result in severe neurological impairment. The current standard of care is the surgical evacuation of CSDH. Although clinical and surgical outcomes are satisfying in most cases, considerable morbidity, mortality and recurrence rates of 3-31% are frequently reported. Therefore a non-surgical approach to treat CSDH is desirable. Tranexamic acid (TXA), an antifibrinolytic drug, has been shown to decrease hematoma volume in a small cohort of CSDH patients. 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 to quantify treatment success. The trial is designed as a double-blinded randomized controlled trial, where half of the patients will be assigned to daily intake of TXA, whereas the other half will receive placebo. The primary endpoint is defined as volume change in milliliter after 4-8 weeks of treatment. Secondary endpoints are hematoma volume at 8-12 weeks, patient safety, the number of patients with resolution of the CSDH after 4-8 and 8-12 weeks of study participation, the neurological outcome, the rate of reoperation, the time to reoperation, drug safety and compatibility, and participant quality of life (QOL).

Conditions

Chronic Subdural Hematoma

Keywords

Tranexamic acid; Chronic Subdural Hematoma; Neurosurgery

Outcome Measures

Primary Outcomes (1)

• Chronic subdural hematoma volume change

  Change in hematoma volume in mL according to CT-scan-based volume measurements comparing hematoma on CT scan performed at 4-8 weeks to hematoma on immediate post-operative CT scan.

  At 4-8 weeks

Secondary Outcomes (8)

• Chronic subdural hematoma volume change

  At 12 weeks

• Rate of adverse events (AEs)

  At 4, 8, and 12 weeks

• 36-Item Short Form Survey (SF-36)

  At 4, 8, 12 weeks

• National Institutes of Health Stroke Scale (NIHSS)

  At 4, 8, and 12 weeks

• Modified Rankin Scale (mRS)

  At 4, 8, and 12 weeks

Study Arms (2)

Tranexamic Acid Arm

EXPERIMENTAL

Participants in the experimental arm will receive tranexamic acid (TXA) during surgery for CSDH evacuation with a single 1000mg intraoperative intravenous (IV) dose. Participants with a body weight 60-100kg will also receive a post-operative dose regimen of 500 mg TXA orally, 3 times a day (TID). Weight deviations from this body weight range will be considered with a dose adjustment of 1000mg TXA two times a day (BID) for a body weight \>100 kg, and 500 mg TXA BID for body weight \<60kg.

Drug: Tranexamic Acid 500 MG

Placebo Control Arm

PLACEBO COMPARATOR

Participants in the control arm will placebo according to the same administration regimen.

Drug: Placebo

Interventions

Tranexamic Acid 500 MG DRUG

Tranexamic Acid 500mg oral tablets

Tranexamic Acid Arm

Placebo DRUG

The placebo will consist of an identical capsule to over-encapsulated tranexamic acid oral tablet entirely filled with microcrystalline cellulose, and sealed.

Placebo Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of chronic subdural hematoma (CSDH)
• Written informed consent (patient, power of attorney or substitute decision maker)
• Competence to take study medication properly and regularly or access to caregiver 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 GFR ≤ 30 mL/min
• Hematuria, caused by diseases of renal parenchyma
• Concomitant intake of hormonal contraceptives, factor IX complex concentrates, and anti-inhibitor coagulant concentrates (factor VII, activated factor IX)
• History of angioplasty with cardiac stent placement, or cardiac (including mechanical) valve placement
• Active history of stroke (hemorrhagic and ischemic), or subarachnoid hemorrhage, within the past 6 months
• Consumption coagulopathy/disseminated intravascular coagulation (DIC) in the last 7 days
• History of malignant brain tumors (glioma, metastasis and others) or seizures within the 6 months
• Contraindication to stopping full therapeutic doses of non-ASA antiplatelets, warfarin, rivaroxaban, apixaban, dabigatran, or other anticoagulant for 2 weeks after surgery
• Inability of oral drug intake or missing support to guarantee oral drug intake
• SDH as caused by intracranial hypotension resulting from CSF shunt placement

Sponsors & Collaborators

• Unity Health Toronto: lead
• The Physicians' Services Incorporated Foundation: collaborator

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B1T8, Canada

Location

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

Study Officials

• Michael D Cusimano, MD, PhD

  St. Michael's Hospital / University of Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael D Cusimano, MD, PhD

CONTACT

(+1)416-864-5312; injuryprevention@smh.ca

Abdelhakim Khellaf, MD

CONTACT

(+1)514-961-1953; abdelhakim.khellaf@mail.utoronto.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2021
• First Posted: May 24, 2021
• Study Start: July 1, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: May 24, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)