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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

Study Description
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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.


Condition or disease Intervention/treatment Phase
Chronic Subdural Hematoma Drug: Tranexamic Acid Drug: Placebo Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Tranexamic Acid in Chronic Subdural Hematomas
Study Start Date : November 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Tranexamic acid
Tranexamic acid 750 mg daily until complete radiological resolution of the chronic subdural hematoma or a maximum of 20 weeks.
 Drug: Tranexamic Acid
Other Name: Cyklokapron
Placebo Comparator: Placebo
Placebo tablet daily until complete radiological resolution of the chronic subdural hematoma or a maximum of 20 weeks.
 Drug: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Hematoma volume [ Time Frame: 20 weeks ]
    Measured by segmentation analysis on the 20 weeks CT scan

  2. Surgical evacuation [ Time Frame: 32 weeks ]
    The incidence of surgical evacuation procedures

  3. Hematoma recurrence [ Time Frame: 32 weeks ]
  4. Cognitive function [ Time Frame: 10 weeks ]
    Assessed by the Montreal Cognitive Assessment (MoCA) and Mini-Mental State Examination (MMSE)

  5. Cognitive function [ Time Frame: 32 weeks ]
    Assessed by the Montreal Cognitive Assessment (MoCA) and Mini-Mental State Examination (MMSE)

  6. Functional autonomy [ Time Frame: 10 weeks ]
    Assessed by the modified Barthel Index (mBI) and Glasgow Outcome Scale Extended (GOSE)

  7. Functional autonomy [ Time Frame: 32 weeks ]
    Assessed by the modified Barthel Index (mBI) and Glasgow Outcome Scale Extended (GOSE)

  8. Quality of life [ Time Frame: 10 weeks ]
    Assessed by the EQ-5D-5L and the Sherbrooke Neuro-oncology Assessment Scale (SNAS)

  9. Quality of life [ Time Frame: 32 weeks ]
    Assessed by the EQ-5D-5L and the Sherbrooke Neuro-oncology Assessment Scale (SNAS)

  10. Length initial of hospital stay [ Time Frame: 32 weeks ]
  11. Number of rehospitalisation [ Time Frame: 32 weeks ]
  12. Complications [ Time Frame: 32 weeks ]
    Incidence of any complication related to tranexamic acid administration


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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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): NCT02568124


Contacts
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Contact: David Mathieu, M.D. 1 (819) 346-1110 ext 74887 david.mathieu@usherbrooke.ca

Locations
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Canada, Alberta
University of Alberta Hospital Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Contact: Sudeshna Bhattacharya    780 934-0280    sbhattac@ualberta.ca   
Principal Investigator: Tim Darsaut         
Canada, Quebec
Centre Hospitalier Universitaire de Sherbrooke Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Contact: Christian Iorio-Morin, M.D., Ph.D.    1 (819) 346-1110    christian.iorio-morin@usherbrooke.ca   
Principal Investigator: Christian Iorio-Morin, M.D., Ph.D.         
Sub-Investigator: David Mathieu, M.D.         
Canada
Centre Hospitalier Affilié Universitaire de Québec Recruiting
Québec, Canada, G1J 1Z4
Contact: Paule Lessard-Bonaventure, M.D.    1 (418) 649-0252    paule.lessard-bonaventure.1@ulaval.ca   
Principal Investigator: Paule Lessard-Bonaventure, M.D.         
Sub-Investigator: Hélène Thida Khuong, M.D.         
Sponsors and Collaborators
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Université de Sherbrooke
Investigators
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Principal Investigator: David Mathieu, M.D. Université de Sherbrooke
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dr David Mathieu, M.D., Centre de recherche du Centre hospitalier universitaire de Sherbrooke
ClinicalTrials.gov Identifier: NCT02568124    
Other Study ID Numbers: 14-213
First Posted: October 5, 2015    Key Record Dates
Last Update Posted: March 19, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Dr David Mathieu, Centre de recherche du Centre hospitalier universitaire de Sherbrooke:
Tranexamic acid
Cyklokapron
Conservative management
Medical management
Additional relevant MeSH terms:
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Hematoma, Subdural
Hematoma, Subdural, Chronic
Hematoma
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