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

NCT ID: NCT04898712

Last Updated: 2021-05-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-31
• Study Completion Date: 2023-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Tranexamic Acid Arm

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.

Group Type: EXPERIMENTAL

Tranexamic Acid 500 MG

Intervention Type: DRUG

Tranexamic Acid 500mg oral tablets

Placebo Control Arm

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Tranexamic Acid 500 MG

Tranexamic Acid 500mg oral tablets

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

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 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Physicians' Services Incorporated Foundation

OTHER

Sponsor Role: collaborator

Unity Health Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael D Cusimano, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

St. Michael's Hospital / University of Toronto

Locations

St. Michael's Hospital

Toronto, Ontario, Canada

Countries

Canada

Central Contacts

Michael D Cusimano, MD, PhD

Role: CONTACT

injuryprevention@smh.ca

(+1)416-864-5312

Abdelhakim Khellaf, MD

Role: CONTACT

abdelhakim.khellaf@mail.utoronto.ca

(+1)514-961-1953

Other Identifiers

17-232

Identifier Type: -

Identifier Source: org_study_id