Tranexamic Acid in Chronic Subdural Hematomas

NCT02568124 | Unknown Phase 2

• 1 other identifier: 14-213
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 3

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.

Conditions

Chronic Subdural Hematoma

Keywords

Tranexamic acid; Cyklokapron; Conservative management; Medical management

Outcome Measures

Primary Outcomes (1)

• Hematoma resolution

  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 Outcomes (12)

• Hematoma volume

  20 weeks

• Surgical evacuation

  32 weeks

• Hematoma recurrence

  32 weeks

• Cognitive function

  10 weeks

• Cognitive function

  32 weeks

Study Arms (2)

Tranexamic acid

EXPERIMENTAL

Tranexamic acid 750 mg daily until complete radiological resolution of the chronic subdural hematoma or a maximum of 20 weeks.

Drug: Tranexamic Acid

Placebo

PLACEBO COMPARATOR

Placebo tablet daily until complete radiological resolution of the chronic subdural hematoma or a maximum of 20 weeks.

Drug: Placebo

Interventions

Tranexamic Acid DRUG

Also known as: Cyklokapron

Tranexamic acid

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Centre de recherche du Centre hospitalier universitaire de Sherbrooke: lead
• Université de Sherbrooke: collaborator

Study Sites (3)

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

RECRUITING

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

RECRUITING

Centre Hospitalier Affilié Universitaire de Québec

Québec, G1J 1Z4, Canada

RECRUITING

Related Publications (1)

• 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.

  PMID: 27150916 DERIVED

MeSH Terms

Conditions

Hematoma, Subdural, Chronic

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Hematoma, Subdural; 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; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematoma; Hemorrhage; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• David Mathieu, M.D.

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Mathieu, M.D.

CONTACT

1 (819) 346-1110; david.mathieu@usherbrooke.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: October 1, 2015
• First Posted: October 5, 2015
• Study Start: November 1, 2015
• Primary Completion: December 1, 2024
• Study Completion: June 1, 2025
• Last Updated: September 5, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share

Locations

CA (3)