Back to results

Tranexamic Acid in the Treatment of Residual Chronic Subdural Hematoma (TRACE)

Primary Purpose

Chronic Subdural Hematoma

Status

Unknown status

Phase

Phase 3

Locations

Canada

Study Type

Interventional

Intervention

Tranexamic Acid 500 MG

About this trial

This is an interventional treatment trial for Chronic Subdural Hematoma focused on measuring Chronic subdural hematoma, Tranexamic acid, TXA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Patients diagnosed with chronic subdural hematoma, and have a planned or have received a unilateral or bilateral burr-hole craniostomy or mini-craniotomy
Written informed consent (patient, power of attorney or substitute decision maker)
Competence to take study medication properly and regularly or access to care giver that is able to comply with accurate study medication administration

Exclusion Criteria:

Hypersensitivity to TXA or any of the ingredients
Pregnancy
Irregular menstrual bleeding with unidentified cause
Acquired colour vision disturbances
Acute and chronic renal insufficiency indicated by glomerular filtration rate (GFR) ≤ 30 mL/min
Hematuria, caused by diseases of renal parenchyma
Current alcohol abuse (as indicated by an Alcohol Use Disorders Identification Test (AUDIT) score of 10 or higher) drug abuse, or recreational drug use
Concomitant intake of hormonal contraceptives, factor IX complex concentrates, and anti-inhibitor coagulant concentrates (factor VII, activated factor IX)
Active, history, or increased risk of thrombotic events (including deep vein thrombosis, pulmonary embolism, cerebral venous thrombosis, arterial thrombotic events), symptomatic carotid stenosis, myocardial infarction, acute coronary syndrome, coronary artery disease, or consumption coagulopathy within the past 2 years
History of angioplasty with cardiac stent placement or mechanical heart valve
Active or history of brain pathologies such as stroke (hemorrhagic and ischemic), subarachnoid hemorrhage, or malignant brain tumors (glioma, metastasis and others) as well as history of seizures within the past 2 years
Contraindication to stopping full therapeutic doses of non-acetylsalicylic acid (ASA) antiplatelets, warfarin, rivaroxaban, apixaban, dabigatran, or other anticoagulant for 2 weeks after surgery
Patients requiring immediate revision surgery (as defined by attending surgeon)
Inability of oral drug intake or missing support to guarantee oral drug intake

Sites / Locations

St. Michael's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Tranexamic Acid Arm

Control Arm

Arm Description

Tranexamic Acid 500 milligrams (MG) Participants of the Tranexamic Acid (TXA) arm will receive the study drug, TXA. Participants of average body weight (60-100kg) will receive TXA according to a 500mg three times daily (TID) dose regimen. Weight deviations from this range will see dose adjustments as follows: participants <60kg will receive 500mg two times daily (BID), and participants >100kg will receive 1000mg BID.

No intervention Participants in the control arm will not receive any additional intervention, medication, or placebo, and will serve as a comparative arm for the experimental arm.

Outcomes

Primary Outcome Measures

Chronic subdural hematoma volume change

Change in hematoma volume in mL according to volume measurements made on CT scans comparing CT scan at 4-8 weeks to immediate post-operative CT scan.

Secondary Outcome Measures

Neurological outcome

An assessment of neurological outcome as measured by the National Institutes of Health Stroke Scale (NIHSS)

Quality of life

Participants quality of life as measured on the Health Utilities Index (HUI).

Quality of life

Participants quality of life as measured on the 36-item Short Form Health Survey (SF-36).

Occurrence of adverse events

Safety of the TXA dose regimen by monitoring incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Full Information

NCT ID

NCT03280212

First Posted

September 10, 2017

Last Updated

September 13, 2017

Sponsor

Unity Health Toronto

1. Study Identification

Unique Protocol Identification Number

NCT03280212

Brief Title

Tranexamic Acid in the Treatment of Residual Chronic Subdural Hematoma

Acronym

TRACE

Official Title

Tranexamic Acid in the Treatment of Residual Chronic Subdural Hematoma: A Single-centre, Observer-blinded, Randomized Controlled Trial.

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Unknown status

Study Start Date

March 6, 2017 (Actual)

Primary Completion Date

March 2018 (Anticipated)

Study Completion Date

March 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Unity Health Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Chronic subdural hematoma (CSDH) is a common disease after minor head trauma, especially in elderly patients. This medical condition is characterized by blood collection in the subdural space, which can result in severe neurological impairment. Current standard of care is the evacuation of the CSDH by means of different surgical approaches. Although clinical and surgical outcomes are satisfying in most cases, considerable morbidity and mortality as well as recurrence rates of 3-31% are frequently reported. Therefore a non-surgical approach for the treatment of CSDH would be desirable. Tranexamic acid (TXA), an antifibrinolytic drug has been shown to decrease hematoma volume in a small cohort of patients suffering from CSDH. The present study is designed to test the hypothesis that TXA can reduce the volume of CSDH. Volume measurements of residual CSDH after burr-hole surgery will be performed during study course to quantify treatment success. The trial is designed as a randomized controlled pilot study, where half of the patients will be assigned to daily intake of TXA, whereas the other half will receive medical treatment according to current practice without TXA prescription. The primary endpoint of the study is defined as volume change in milliliters (mL) after 4-8 weeks of treatment. Secondary endpoints are hematoma volume change at 8-12 weeks, the rate of patients with resolution of the CSDH after 4-8 weeks and 8-12 weeks days, as well as the rate of reoperation during study course due to hematoma extension and neurological deterioration. Additionally the neurological outcome and the drug compatibility will be estimated as secondary objectives.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Subdural Hematoma

Keywords

Chronic subdural hematoma, Tranexamic acid, TXA

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Tranexamic Acid Arm

Arm Type

Experimental

Arm Description

Arm Title

Control Arm

Arm Type

No Intervention

Arm Description

No intervention Participants in the control arm will not receive any additional intervention, medication, or placebo, and will serve as a comparative arm for the experimental arm.

Intervention Type

Drug

Intervention Name(s)

Tranexamic Acid 500 MG

Other Intervention Name(s)

TXA

Intervention Description

Tranexamic Acid 500mg oral tablets.

Primary Outcome Measure Information:

Title

Chronic subdural hematoma volume change

Description

Change in hematoma volume in mL according to volume measurements made on CT scans comparing CT scan at 4-8 weeks to immediate post-operative CT scan.

Time Frame

4-8 weeks, 8-12 weeks

Secondary Outcome Measure Information:

Title

Neurological outcome

Description

An assessment of neurological outcome as measured by the National Institutes of Health Stroke Scale (NIHSS)

Time Frame

4-8 weeks, 8-12 weeks

Title

Quality of life

Description

Participants quality of life as measured on the Health Utilities Index (HUI).

Time Frame

4-8 weeks, 8-12 weeks

Title

Quality of life

Description

Participants quality of life as measured on the 36-item Short Form Health Survey (SF-36).

Time Frame

4-8 weeks, 8-12 weeks

Title

Occurrence of adverse events

Description

Safety of the TXA dose regimen by monitoring incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Time Frame

4-8 weeks, 8-12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients diagnosed with chronic subdural hematoma, and have a planned or have received a unilateral or bilateral burr-hole craniostomy or mini-craniotomy Written informed consent (patient, power of attorney or substitute decision maker) Competence to take study medication properly and regularly or access to care giver that is able to comply with accurate study medication administration Exclusion Criteria: Hypersensitivity to TXA or any of the ingredients Pregnancy Irregular menstrual bleeding with unidentified cause Acquired colour vision disturbances Acute and chronic renal insufficiency indicated by glomerular filtration rate (GFR) ≤ 30 mL/min Hematuria, caused by diseases of renal parenchyma Current alcohol abuse (as indicated by an Alcohol Use Disorders Identification Test (AUDIT) score of 10 or higher) drug abuse, or recreational drug use Concomitant intake of hormonal contraceptives, factor IX complex concentrates, and anti-inhibitor coagulant concentrates (factor VII, activated factor IX) Active, history, or increased risk of thrombotic events (including deep vein thrombosis, pulmonary embolism, cerebral venous thrombosis, arterial thrombotic events), symptomatic carotid stenosis, myocardial infarction, acute coronary syndrome, coronary artery disease, or consumption coagulopathy within the past 2 years History of angioplasty with cardiac stent placement or mechanical heart valve Active or history of brain pathologies such as stroke (hemorrhagic and ischemic), subarachnoid hemorrhage, or malignant brain tumors (glioma, metastasis and others) as well as history of seizures within the past 2 years Contraindication to stopping full therapeutic doses of non-acetylsalicylic acid (ASA) antiplatelets, warfarin, rivaroxaban, apixaban, dabigatran, or other anticoagulant for 2 weeks after surgery Patients requiring immediate revision surgery (as defined by attending surgeon) Inability of oral drug intake or missing support to guarantee oral drug intake

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Adriana M Workewych, HBSc

Phone

416-864-5312

workewycha@smh.ca

First Name & Middle Initial & Last Name or Official Title & Degree

Stanley Zhang

Phone

416-864-5312

zhangsh@smh.ca

Facility Information:

Facility Name

St. Michael's Hospital

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5B 1W8

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Adriana M Workewych, HBSc

Phone

416-864-5312

workewycha@smh.ca

First Name & Middle Initial & Last Name & Degree

Michael D Cusimano, Md, PhD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Tranexamic Acid in the Treatment of Residual Chronic Subdural Hematoma

We'll reach out to this number within 24 hrs