Tranexamic Acid in Chronic Subdural Hematomas

• Register: ClinicalTrials.gov
• Last refreshed on: 11 September 2023
• Main ID: NCT02568124
• Date of registration: 01/10/2015
• Prospective Registration: Yes
• Primary sponsor: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
• Public title: Tranexamic Acid in Chronic Subdural Hematomas TRACS
• Scientific title: Tranexamic Acid in Chronic Subdural Hematomas
• Date of first enrolment: November 2015
• Target sample size: 130
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT02568124
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2/Phase 3

Countries of recruitment

Canada

Contacts

• Name: David Mathieu, M.D.

• Name: David Mathieu, M.D.
• Affiliation: Université de Sherbrooke

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Subdural Hematoma

Intervention(s)

Drug: Placebo

Drug: Tranexamic Acid

Primary Outcome(s)

Hematoma resolution [Time Frame: 20 weeks]

Secondary Outcome(s)

Length initial of hospital stay [Time Frame: 32 weeks]

Cognitive function [Time Frame: 32 weeks]

Number of rehospitalisation [Time Frame: 32 weeks]

Cognitive function [Time Frame: 10 weeks]

Hematoma recurrence [Time Frame: 32 weeks]

Functional autonomy [Time Frame: 32 weeks]

Surgical evacuation [Time Frame: 32 weeks]

Complications [Time Frame: 32 weeks]

Functional autonomy [Time Frame: 10 weeks]

Quality of life scores at 32 weeks [Time Frame: 32 weeks]

Hematoma volume [Time Frame: 20 weeks]

Quality of life scores at 10 weeks [Time Frame: 10 weeks]

Secondary ID(s)

14-213

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Université de Sherbrooke