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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
Sponsored by
Unity Health Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

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

First Posted
September 10, 2017
Last Updated
September 13, 2017
Sponsor
Unity Health Toronto
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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
No
Studies a U.S. FDA-regulated Device Product
No
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
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.
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
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
Email
workewycha@smh.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Stanley Zhang
Phone
416-864-5312
Email
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
Email
workewycha@smh.ca
First Name & Middle Initial & Last Name & Degree
Michael D Cusimano, Md, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Tranexamic Acid in the Treatment of Residual Chronic Subdural Hematoma

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