A Study on the Safety of Tranexamic Acid for the Chronic Subdural Hematoma Population
Condition: Subdural Hematoma
MeSH terms: Hematoma, Subdural; Hematoma, Subdural, Chronic; Hematoma
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      Chronic subdural hematomas are a common problem faced by neurosurgery with an annual
      incidence of 13.5/100,00 persons per year and up to 58/100,000 in the over 65 years old
      population. Their treatment is often complicated by recurrence with rates reported as high as
      33%. Currently there is no good strategy to help avoid this problem, which adds significantly
      to patient morbidity. The pathogenesis of this problem is believed to be related to the
      propensity of the associated neo-membranes to bleed. It has been shown with labeled red blood
      cells that bleeding continues to occur into the hematoma cavity. It has also been shown that
      there are high levels of tissue plasminogen activator in the outer membrane of chronic
      subdural hematomas. It has been found that ratio of tissue plasminogen activator to
      plasminogen activator inhibitor contributed to the pathogenesis. It has also been shown that
      chronic subdural hematomas have high levels of fibrin degradation products which in addition
      to marking the breakdown of fibrin are themselves antihemostatic by enhancing tissue
      plasminogen activator activity, having an antithrombin affect and inhibiting platelet
      aggregation and fibrin polymerization. Essentially, a scenario of ongoing hemorrhage and
      repeated clot formation and hyperfibrinolysis leads to the expansion and recurrence of
      chronic subdural hematomas.

      Given the importance of plasmin and hyperfibrinolysis in the pathophysiology of chronic
      subdural hematomas, interrupting its action and the vicious cycle it propagates seems an
      ideal therapeutic target. Tranexamic acid is a synthetic lysine amino acid derivative. It
      binds to the fibrin binding sites on plasmin or plasminogen and prevents its interaction and
      degradation of fibrin. This effect on the neo-membranes of chronic subdural hematomas should
      prevent rebleeding and the reaccumulation of the subdural hematoma.

      Tranexamic acid has been shown to be safe and effective in reducing blood loss and
      transfusions in a number of types of surgery, reduced mortality and need for urgent surgery
      in patients with GI bleeding, and reduced bleeding associated with menorrhagia and pregnancy.
      Adverse effects are generally mild. Thought there is a theoretical increased risk of
      thromboembolic complications, multiple randomized controlled trials have not shown an
      increased risk. Furthermore, in a study of over 3000 gynecologic patients using tranexamic
      acid, there were no thromboembolic complications. This is likely because tranexamic acid has
      been shown to not have an effect on plasminogen in the vein wall.
    

Intervention name(s): Tranexamic Acid
Intervention type(s): Drug
Intervention description(s): 1300mg tranexamic acid by mouth once before surgery and then three times a day for up to three days or until they are discharged from the hospital, whichever comes first
Other intervention name(s): Lysteda; Cyklokapron
Intervention MeSH terms: Tranexamic Acid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment