Tranexamic Acid in Chronic Subdural Hematomas (TRACS)

August 31, 2023 updated by: Dr David Mathieu, Centre de recherche du Centre hospitalier universitaire de Sherbrooke

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

130

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
      • Québec, Canada, G1J 1Z4
        • Recruiting
        • Centre hospitalier affilié universitaire de Québec
        • Contact:
        • Principal Investigator:
          • Paule Lessard-Bonaventure, M.D.
        • Sub-Investigator:
          • Hélène Thida Khuong, M.D.
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • Recruiting
        • University of Alberta Hospital
        • Contact:
        • Principal Investigator:
          • Tim Darsaut
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Recruiting
        • Centre Hospitalier Universitaire de Sherbrooke
        • Contact:
        • Principal Investigator:
          • Christian Iorio-Morin, M.D., Ph.D.
        • Sub-Investigator:
          • David Mathieu, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • Cyklokapron
Placebo Comparator: Placebo
Placebo tablet daily until complete radiological resolution of the chronic subdural hematoma or a maximum of 20 weeks.
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
20 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hematoma volume
Time Frame: 20 weeks
Measured by segmentation analysis on the 20 weeks CT scan
20 weeks
Surgical evacuation
Time Frame: 32 weeks
The incidence of surgical evacuation procedures
32 weeks
Hematoma recurrence
Time Frame: 32 weeks
32 weeks
Cognitive function
Time Frame: 10 weeks
Assessed by the Montreal Cognitive Assessment (MoCA) and Mini-Mental State Examination (MMSE)
10 weeks
Cognitive function
Time Frame: 32 weeks
Assessed by the Montreal Cognitive Assessment (MoCA) and Mini-Mental State Examination (MMSE)
32 weeks
Functional autonomy
Time Frame: 10 weeks
Assessed by the modified Barthel Index (mBI) and Glasgow Outcome Scale Extended (GOSE)
10 weeks
Functional autonomy
Time Frame: 32 weeks
Assessed by the modified Barthel Index (mBI) and Glasgow Outcome Scale Extended (GOSE)
32 weeks
Length initial of hospital stay
Time Frame: 32 weeks
32 weeks
Number of rehospitalisation
Time Frame: 32 weeks
32 weeks
Complications
Time Frame: 32 weeks
Incidence of any complication related to tranexamic acid administration
32 weeks
Quality of life scores at 10 weeks
Time Frame: 10 weeks
Assessed by the EQ-5D-5L and the Sherbrooke Neuro-oncology Assessment Scale (SNAS)
10 weeks
Quality of life scores at 32 weeks
Time Frame: 32 weeks
Assessed by the EQ-5D-5L and the Sherbrooke Neuro-oncology Assessment Scale (SNAS)
32 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Collaborators

Université de Sherbrooke

Investigators

  • Principal Investigator: David Mathieu, M.D., Université de Sherbrooke

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

October 1, 2015

First Submitted That Met QC Criteria

October 1, 2015

First Posted (Estimated)

October 5, 2015

Study Record Updates

Last Update Posted (Actual)

September 5, 2023

Last Update Submitted That Met QC Criteria

August 31, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-213

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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