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

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ClinicalTrials.gov Identifier: NCT02618382
Recruitment Status : Unknown
Verified December 2016 by Madelon Petersen, St. Joseph's Hospital and Medical Center, Phoenix.
Recruitment status was:  Recruiting
First Posted : December 1, 2015
Last Update Posted : December 13, 2016
Sponsor:
Collaborator:
Barrow Neurological Foundation
Information provided by (Responsible Party):
Madelon Petersen, St. Joseph's Hospital and Medical Center, Phoenix

Brief 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.

Condition or disease Intervention/treatment Phase
Subdural Hematoma Drug: Tranexamic Acid Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : November 2015
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: All subjects
Patients will undergo standard treatment of their chronic subdural hematoma with the addition of preoperative and postoperative oral tranexamic acid treatment. Patients will receive a dose of 1300mg orally three to four hours prior to surgery. They will then take 1300mg orally three times daily for three days or until discharge, whichever occurs first.
Drug: Tranexamic Acid
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 Names:
  • Lysteda
  • Cyklokapron




Primary Outcome Measures :
  1. Medication Related Complications [ Time Frame: 30 days ]
    occurrence of stroke, myocardial infarction, deep vein thrombosis, and/or pulmonary embolism


Secondary Outcome Measures :
  1. Postoperative hematoma expansion assessed by preoperative CT comparing width of hematoma to postoperative CTs [ Time Frame: postoperative days 1, 3, 7, and 30+/-7 days ]
    preoperative CT comparing width of hematoma to postoperative CTs

  2. Modified Rankin Scale (mRS) [ Time Frame: preoperative (Day 0) and postoperative (day 30) ]
    postoperative score will equal or exceed preoperative score

  3. National Institute of Health Stroke Scale (NIHSS) [ Time Frame: immediately preoperative (Day 0) and discharge (up to 30 days postoperative) ]
    postoperative score will equal or exceed preoperative score



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02618382


Contacts
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Contact: Heidi Jahnke, RN, MSN 602-406-6976 heidi.jahnke@dignityhealth.org

Locations
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United States, Arizona
Barrow Brain and Spine Recruiting
Phoenix, Arizona, United States, 85013
Contact: Heidi Jahnke, RN, MSN    602-406-6976    heidi.jahnke@dignityhealth.org   
Principal Investigator: Andrew S Little, MD         
Sub-Investigator: Rami Almefty, MD         
Sponsors and Collaborators
St. Joseph's Hospital and Medical Center, Phoenix
Barrow Neurological Foundation
Investigators
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Principal Investigator: Andrew S Little, MD Barrow Brain and Spine, Phoenix, AZ

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Responsible Party: Madelon Petersen, Investigator, St. Joseph's Hospital and Medical Center, Phoenix
ClinicalTrials.gov Identifier: NCT02618382     History of Changes
Other Study ID Numbers: PHX15BN048
First Posted: December 1, 2015    Key Record Dates
Last Update Posted: December 13, 2016
Last Verified: December 2016

Additional relevant MeSH terms:
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Hematoma
Hematoma, Subdural
Hemorrhage
Pathologic Processes
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
Wounds and Injuries
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants