A Study on the Safety of Tranexamic Acid for the Chronic Subdural Hematoma Population

• Status: Completed
• Trial end date: 2018-06-12
• Target enrollment: 0
• Participant gender: All

Summary

This is a single center single arm study of 50 patients to 1) determine the safety of tranexamic acid in the chronic subdural hematoma population following surgical drainage of chronic subdural hematomas and 2) determine if the use of oral tranexamic acid reduces the rate of ipsilateral recurrence following drainage of chronic subdural hematomas. This will be compared to historical controls. This study intends to be a prerequisite to a large nationally funded randomized control trial.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Joseph's Hospital and Medical Center, Phoenix
• Collaborator: Barrow Neurological Foundation
• Treatments: Tranexamic Acid

Criteria

Inclusion Criteria:

• all patients undergoing intervention for chronic subdural hematoma (cSDH) including drainage

• cSDH will be defined as hematoma on CT imaging that is predominantly iso- to hypodense to brain

• 18-85 years of age

Exclusion Criteria:

• cSDH not requiring surgical drainage

• patients undergoing bedside twist drill craniostomy

• medically unstable for surgery

• patients requiring long-term anticoagulation (unable to stay off for less than 30 days)

• patients not expected to survive to the completion of followup

• patients comatose prior to the initiation of treatment

• history of thromboembolic problem including stroke, myocardial infarction, deep vein thrombosis and/or pulmonary embolism

• pregnant

• minor

• allergy/sensitivity to tranexamic acid

• irreversible coagulopathy

• known clotting disorder

• bilateral hematomas with both requiring drainage

• incarcerated

• any patient not judged suitable for the study by the investigators

• women who are taking combination hormonal contraception