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Tranexamic Acid in Chronic Subdural Hematomas (TRACS)

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ClinicalTrials.gov Identifier: NCT02568124
Recruitment Status : Recruiting
First Posted : October 5, 2015
Last Update Posted : March 19, 2020
Sponsor:
Collaborator:
Université de Sherbrooke
Information provided by (Responsible Party):
Dr David Mathieu, Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Tracking Information
First Submitted Date  ICMJE October 1, 2015
First Posted Date  ICMJE October 5, 2015
Last Update Posted Date March 19, 2020
Study Start Date  ICMJE November 2015
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 1, 2015)
Hematoma resolution [ Time Frame: 20 weeks ]
The rate of chronic subdural hematoma resolution without intervening unplanned surgical procedure. Specifically, if the initial management strategy chosen by the attending physician within the first 24 hours of presentation consists of expectant management, any surgical procedure leads to a failure of meeting the primary outcome. On the other hand, if the management strategy chosen by the attending physician within the first 24 hours of presentation included a surgical evacuation of the CSDH, the primary outcome is met if the control CT scan at 20 weeks demonstrates a complete radiological resolution of the CSDH. Should a second surgery be required, the subject will fail to meet the primary outcome even if the CSDH has completely resolved by 20 weeks.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 1, 2015)
  • Hematoma volume [ Time Frame: 20 weeks ]
    Measured by segmentation analysis on the 20 weeks CT scan
  • Surgical evacuation [ Time Frame: 32 weeks ]
    The incidence of surgical evacuation procedures
  • Hematoma recurrence [ Time Frame: 32 weeks ]
  • Cognitive function [ Time Frame: 10 weeks ]
    Assessed by the Montreal Cognitive Assessment (MoCA) and Mini-Mental State Examination (MMSE)
  • Cognitive function [ Time Frame: 32 weeks ]
    Assessed by the Montreal Cognitive Assessment (MoCA) and Mini-Mental State Examination (MMSE)
  • Functional autonomy [ Time Frame: 10 weeks ]
    Assessed by the modified Barthel Index (mBI) and Glasgow Outcome Scale Extended (GOSE)
  • Functional autonomy [ Time Frame: 32 weeks ]
    Assessed by the modified Barthel Index (mBI) and Glasgow Outcome Scale Extended (GOSE)
  • Quality of life [ Time Frame: 10 weeks ]
    Assessed by the EQ-5D-5L and the Sherbrooke Neuro-oncology Assessment Scale (SNAS)
  • Quality of life [ Time Frame: 32 weeks ]
    Assessed by the EQ-5D-5L and the Sherbrooke Neuro-oncology Assessment Scale (SNAS)
  • Length initial of hospital stay [ Time Frame: 32 weeks ]
  • Number of rehospitalisation [ Time Frame: 32 weeks ]
  • Complications [ Time Frame: 32 weeks ]
    Incidence of any complication related to tranexamic acid administration
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 Chronic Subdural Hematomas
Official Title  ICMJE Tranexamic Acid in Chronic Subdural Hematomas
Brief Summary

BACKGROUND Chronic subdural hematoma (CSDH) is one of the most frequent reasons for cranial neurosurgical consult. There is no widely accepted medical treatment for CSDH.

This trial will investigate whether Tranexamic Acid (TXA) can increase the rate of CSDH resolution following conservative management, lower the number of required surgical procedures and decrease the rate of CSDH recurrence following surgical evacuation. TRACS is a double blind, randomized, parallel-design, placebo-controlled, phase IIB study designed to provide preliminary efficacy data as well as feasibility, safety and incidence data required to plan a larger definitive phase III trial.

METHODS Consecutive patients presenting at the Centre Hospitalier Universitaire de Sherbrooke with a recent (< 14 days) diagnosis of subdural hematoma with a chronic component will be screened for eligibility. Exclusion criteria include specific risk factors for thromboembolic disease, anticoagulant use or contraindication to TXA. A total of 130 patients will be randomized to receive either 750 mg of TXA daily or placebo until complete radiological resolution of the CSDH or for a maximum of 20 weeks. CSDH volume will be measured on serial CT scanning. Cognitive function tests, quality of life questionnaires as well as functional autonomy assessments will be performed at enrollment, 10 weeks follow-up and 3 months post-treatment follow-up. During the treatment period, patients will undergo standard CSDH management with surgery being performed at the discretion of the treating physician. If surgery is performed, the CSDH and its outer membrane will be sampled for in vitro analysis.

The primary outcome is the rate of CSDH resolution at 20 weeks without intervening unplanned surgical procedure. Secondary outcomes include CSDH volume, incidence of surgical evacuation procedures, CSDH recurrence, cognitive functions, functional autonomy, quality of life, incidence of complications and length of hospital stay. Planned subgroup analyses will be performed for conservatively vs surgically-managed subjects and highly vs poorly vascularised CSDH.

DISCUSSION CSDH is a frequent and morbid condition for which an effective medical treatment has yet to be discovered. The TRACS trial will be the first prospective study of TXA for CSDH.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Subdural Hematoma
Intervention  ICMJE
  • Drug: Tranexamic Acid
    Other Name: Cyklokapron
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: Tranexamic acid
    Tranexamic acid 750 mg daily until complete radiological resolution of the chronic subdural hematoma or a maximum of 20 weeks.
    Intervention: Drug: Tranexamic Acid
  • Placebo Comparator: Placebo
    Placebo tablet daily until complete radiological resolution of the chronic subdural hematoma or a maximum of 20 weeks.
    Intervention: Drug: Placebo
Publications * Iorio-Morin C, Blanchard J, Richer M, Mathieu D. Tranexamic Acid in Chronic Subdural Hematomas (TRACS): study protocol for a randomized controlled trial. Trials. 2016 May 5;17(1):235. doi: 10.1186/s13063-016-1358-5.

*   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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 1, 2015)
130
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • CT scan demonstrating the existence of a subdural hematoma containing a chronic component
  • Diagnosis within the last 14 days

Exclusion Criteria:

  • Acute subdural hematoma with no chronic component;
  • Active thrombotic, thromboembolic or atheroembolic disease, including deep venous thrombosis within the last six months, cerebral thrombosis within the last six months, symptomatic carotid stenosis who did not undergo surgery or stroke within the last year;
  • Past history of unprovoked deep venous thrombosis or idiopathic pulmonary embolism;
  • Known hereditary thrombophilia, including Factor V Leiden, Antithrombin III mutation, Protein C deficiency, Protein S deficiency;
  • Atrial fibrillation (unless under successful rhythm control therapy);
  • Metallic heart valve;
  • Vascular stenting procedure within the last year;
  • Cardiac or vascular surgical procedure within the last 6 months, including endarterectomy, bypass or angioplasty;
  • Ongoing investigation for suspected malignancy;
  • Confirmed active malignancy;
  • Concomitant hormone therapy for malignancy;
  • Concomitant hormone contraceptive pill;
  • Macroscopic hematuria;
  • Known or suspected tranexamic acid allergy;
  • Pregnancy or breastfeeding;
  • Concomitant use of anticoagulant medication;
  • Any concern from the attending physician.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: David Mathieu, M.D. 1 (819) 346-1110 ext 74887 david.mathieu@usherbrooke.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02568124
Other Study ID Numbers  ICMJE 14-213
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Dr David Mathieu, Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Study Sponsor  ICMJE Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Collaborators  ICMJE Université de Sherbrooke
Investigators  ICMJE
Principal Investigator: David Mathieu, M.D. Université de Sherbrooke
PRS Account Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Verification Date March 2020

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