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Tranexamic Acid in the Treatment of Residual Chronic Subdural Hematoma (TRACE)

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: NCT03280212
Recruitment Status : Unknown
Verified September 2017 by Michael Cusimano, St. Michael's Hospital, Toronto.
Recruitment status was:  Recruiting
First Posted : September 12, 2017
Last Update Posted : September 14, 2017
Sponsor:
Information provided by (Responsible Party):
Michael Cusimano, St. Michael's Hospital, Toronto

Tracking Information
First Submitted Date  ICMJE September 10, 2017
First Posted Date  ICMJE September 12, 2017
Last Update Posted Date September 14, 2017
Actual Study Start Date  ICMJE March 6, 2017
Estimated Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2017)
Chronic subdural hematoma volume change [ Time Frame: 4-8 weeks, 8-12 weeks ]
Change in hematoma volume in mL according to volume measurements made on CT scans comparing CT scan at 4-8 weeks to immediate post-operative CT scan.
Original Primary Outcome Measures  ICMJE
 (submitted: September 11, 2017)
Chronic subdural hematoma volume change [ Time Frame: 4-8 weeks, 8-12 weeks ]
Change in hematoma volume in mL according to volume measurements made on CT scans comparing CT scan at 4-6 weeks to immediate post-operative CT scan.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2017)
  • Neurological outcome [ Time Frame: 4-8 weeks, 8-12 weeks ]
    An assessment of neurological outcome as measured by the National Institutes of Health Stroke Scale (NIHSS)
  • Quality of life [ Time Frame: 4-8 weeks, 8-12 weeks ]
    Participants quality of life as measured on the Health Utilities Index (HUI).
  • Quality of life [ Time Frame: 4-8 weeks, 8-12 weeks ]
    Participants quality of life as measured on the 36-item Short Form Health Survey (SF-36).
  • Occurrence of adverse events [ Time Frame: 4-8 weeks, 8-12 weeks ]
    Safety of the TXA dose regimen by monitoring incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
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 Tranexamic Acid in the Treatment of Residual Chronic Subdural Hematoma
Official Title  ICMJE Tranexamic Acid in the Treatment of Residual Chronic Subdural Hematoma: A Single-centre, Observer-blinded, Randomized Controlled Trial.
Brief Summary Chronic subdural hematoma (CSDH) is a common disease after minor head trauma, especially in elderly patients. This medical condition is characterized by blood collection in the subdural space, which can result in severe neurological impairment. Current standard of care is the evacuation of the CSDH by means of different surgical approaches. Although clinical and surgical outcomes are satisfying in most cases, considerable morbidity and mortality as well as recurrence rates of 3-31% are frequently reported. Therefore a non-surgical approach for the treatment of CSDH would be desirable. Tranexamic acid (TXA), an antifibrinolytic drug has been shown to decrease hematoma volume in a small cohort of patients suffering from CSDH. 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 during study course to quantify treatment success. The trial is designed as a randomized controlled pilot study, where half of the patients will be assigned to daily intake of TXA, whereas the other half will receive medical treatment according to current practice without TXA prescription. The primary endpoint of the study is defined as volume change in milliliters (mL) after 4-8 weeks of treatment. Secondary endpoints are hematoma volume change at 8-12 weeks, the rate of patients with resolution of the CSDH after 4-8 weeks and 8-12 weeks days, as well as the rate of reoperation during study course due to hematoma extension and neurological deterioration. Additionally the neurological outcome and the drug compatibility will be estimated as secondary objectives.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Subdural Hematoma
Intervention  ICMJE Drug: Tranexamic Acid 500 MG
Tranexamic Acid 500mg oral tablets.
Other Name: TXA
Study Arms  ICMJE
  • Experimental: Tranexamic Acid Arm

    Tranexamic Acid 500 milligrams (MG)

    Participants of the Tranexamic Acid (TXA) arm will receive the study drug, TXA. Participants of average body weight (60-100kg) will receive TXA according to a 500mg three times daily (TID) dose regimen. Weight deviations from this range will see dose adjustments as follows: participants <60kg will receive 500mg two times daily (BID), and participants >100kg will receive 1000mg BID.

    Intervention: Drug: Tranexamic Acid 500 MG
  • No Intervention: Control Arm

    No intervention

    Participants in the control arm will not receive any additional intervention, medication, or placebo, and will serve as a comparative arm for the experimental arm.

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: September 11, 2017)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2018
Estimated Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients diagnosed with chronic subdural hematoma, and have a planned or have received a unilateral or bilateral burr-hole craniostomy or mini-craniotomy
  • Written informed consent (patient, power of attorney or substitute decision maker)
  • Competence to take study medication properly and regularly or access to care giver 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 glomerular filtration rate (GFR) ≤ 30 mL/min
  • Hematuria, caused by diseases of renal parenchyma
  • Current alcohol abuse (as indicated by an Alcohol Use Disorders Identification Test (AUDIT) score of 10 or higher) drug abuse, or recreational drug use
  • Concomitant intake of hormonal contraceptives, factor IX complex concentrates, and anti-inhibitor coagulant concentrates (factor VII, activated factor IX)
  • Active, history, or increased risk of thrombotic events (including deep vein thrombosis, pulmonary embolism, cerebral venous thrombosis, arterial thrombotic events), symptomatic carotid stenosis, myocardial infarction, acute coronary syndrome, coronary artery disease, or consumption coagulopathy within the past 2 years
  • History of angioplasty with cardiac stent placement or mechanical heart valve
  • Active or history of brain pathologies such as stroke (hemorrhagic and ischemic), subarachnoid hemorrhage, or malignant brain tumors (glioma, metastasis and others) as well as history of seizures within the past 2 years
  • Contraindication to stopping full therapeutic doses of non-acetylsalicylic acid (ASA) antiplatelets, warfarin, rivaroxaban, apixaban, dabigatran, or other anticoagulant for 2 weeks after surgery
  • Patients requiring immediate revision surgery (as defined by attending surgeon)
  • Inability of oral drug intake or missing support to guarantee oral drug intake
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03280212
Other Study ID Numbers  ICMJE 14-0176-GAP
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Michael Cusimano, St. Michael's Hospital, Toronto
Study Sponsor  ICMJE St. Michael's Hospital, Toronto
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account St. Michael's Hospital, Toronto
Verification Date September 2017

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