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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE November 23, 2015
First Posted Date  ICMJE December 1, 2015
Last Update Posted Date December 13, 2016
Study Start Date  ICMJE November 2015
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 25, 2015)
Medication Related Complications [ Time Frame: 30 days ]
occurrence of stroke, myocardial infarction, deep vein thrombosis, and/or pulmonary embolism
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 25, 2015)
  • 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
  • Modified Rankin Scale (mRS) [ Time Frame: preoperative (Day 0) and postoperative (day 30) ]
    postoperative score will equal or exceed preoperative score
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study on the Safety of Tranexamic Acid for the Chronic Subdural Hematoma Population
Official Title  ICMJE Not Provided
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Subdural Hematoma
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Drug: Tranexamic Acid
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 25, 2015)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2018
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02618382
Other Study ID Numbers  ICMJE PHX15BN048
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Madelon Petersen, St. Joseph's Hospital and Medical Center, Phoenix
Study Sponsor  ICMJE St. Joseph's Hospital and Medical Center, Phoenix
Collaborators  ICMJE Barrow Neurological Foundation
Investigators  ICMJE
Principal Investigator: Andrew S Little, MD Barrow Brain and Spine, Phoenix, AZ
PRS Account St. Joseph's Hospital and Medical Center, Phoenix
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP