Tranexamic Acid to Prevent OpeRation in Chronic Subdural Hematoma (TORCH)
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|ClinicalTrials.gov Identifier: NCT03582293|
Recruitment Status : Recruiting
First Posted : July 11, 2018
Last Update Posted : July 11, 2018
Rationale: Chronic subdural hematoma (cSDH) is a relatively frequently occurring neurological disease, occurring mainly in the elderly. Surgical evacuation of the hematoma is an effective treatment, but is also associated with life-threatening risks. In these old, often frail, patients with multi-comorbidity, surgery also comes with significant risks for future cognitive functioning and, therefore, loss of independency. In five small retrospective series, tranexamic acid (TXA), an antifibrinolytic drug, showed a beneficial effect on the spontaneous resolution of the hematoma and, with that, the necessity for surgery. This randomised, placebo-controlled clinical trial aims to prove the efficacy of TXA.
Objectives: Primarily to evaluate the efficacy of TXA to prevent surgery for cSDH. Secondarily to evaluate the efficacy of TXA to reduce cSDH volume, to reduce neurological impairment (mNIHSS), to reduce the incidence of falling incidents, to improve cognitive functioning (MOCA), to improve performance in activities of daily living (Barthel and Lawton-Brody), to improve functional outcome (mRS), to improve the level of quality of life, to reduce the mortality rate and to reduce the use of care and health-related costs (iMCQ and iPCQ).
Study design: Double-blind, placebo-controlled, multicentre, randomized clinical trial.
Study population: All patients, age 50 and above, diagnosed with cSDH for which a conservative treatment is selected as primary treatment strategy.
Intervention: During four weeks, the intervention group will receive oral TXA 500mg twice daily, the control group will receive a placebo twice daily. The TXA or placebo treatment is additional to standard care.
Main study endpoint: The number of patients requiring surgery within 12 weeks after start of treatment.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients will use the study medication twice daily for four weeks. Follow-up is at four, eight and 12 weeks with a standard CT-scan of the head, outpatient clinic visits and four patient-reported questionnaires (at baseline and at 12 weeks). These outpatient clinic visits are standard care; the third CT-scan, the questionnaires and extra clinical tests during the visits are extra for this study. Each patient may benefit from the study if the study medication proves effective in preventing surgery for cSDH, whereas the risk of potential side effects of the medication is slight (e.g. the risk of thromboembolic events is only 0.01-0.1%). Surgery remains a possibility for those patients in whom study medication is not effective.
|Condition or disease||Intervention/treatment||Phase|
|Hematoma, Subdural, Chronic||Drug: Tranexamic Acid 500Mg Tablet Drug: Placebo oral capsule||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||130 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Double-blind, placebo-controlled, multicentre, randomized clinical trial.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Tranexamic Acid to Prevent OpeRation in Chronic Subdural Hematoma. A Double-blind, Placebo-controlled, Multicentre, Randomized Controlled Clinical Trial|
|Actual Study Start Date :||June 19, 2018|
|Estimated Primary Completion Date :||September 20, 2021|
|Estimated Study Completion Date :||December 31, 2021|
Active Comparator: Tranexamic Acid
Tranexamic acid 500mg two times a day orally for a total of 28 days
Drug: Tranexamic Acid 500Mg Tablet
orally twice daily for 28 days
Other Name: cyclokapron
Placebo Comparator: PLACEBO
Placebo capsules two times a day orally for a total of 28 days
Drug: Placebo oral capsule
Oral placebo capsule two times a day for a total of 28 days
- surgery for cSDH [ Time Frame: within 12 weeks after start of treatment ]number of patients who need to undergo surgery for cSDH
- cSDH volume [ Time Frame: at four, eight and 12 weeks ]change in cSDH volume (in ml) on follow-up CT scan of the head
- neurological impairment [ Time Frame: at four, eight and 12 weeks ]neurological impairment measured with the modified National Institutes of Health Stroke Scale (mNIHSS) score, range 0 (normal) to 31 (severe neurological deficit)
- falling incidents [ Time Frame: during the 12 week study period ]number of falling incidents during study period
- cognitive functioning [ Time Frame: at four, eight and 12 weeks ]cognitive functioning measured with the Montreal Cognitive Assessment (MOCA) test, range 0 - 30, with a score of 26 and higher generally considered normal.
- performance in activities of daily living [ Time Frame: at 12 weeks ]performance in activities of daily measured with the Barthel Index scale (range 0-20, with lower scores indicating increased disability)
- functional outcome [ Time Frame: at 12 weeks ]functional outcome measured with the modified Rankin Scale (mRS) score, range 0 (no symptoms) to 6 (death)
- patient health status [ Time Frame: at 12 weeks ]quality of life measured with the patient-reported Short Form Health Survey questionnaire (SF-36; eight scaled scores, range 0 (maximum disability) -100 (no disability).
- mortality rate [ Time Frame: at 12 weeks ]number and percentage of deaths during study period
- use of care [ Time Frame: during the 12 week study period ]use of care measured with the Medical Consumption Questionnaire (iMCQ), which includes questions related to frequently occurring contacts with health care providers
- performance in activities of daily living [ Time Frame: at 12 weeks ]performance in activities of daily measured with the Lawton-Brody scale, range 0 (low function, dependent) to 8 (high function, independent).
- health-related costs [ Time Frame: during the 12 week study period ]health-related costs measured with the Productivity Cost Questionnaire (iPCQ), a standardized instrument including three modules for measuring and valuing productivity losses of paid work due to 1) absenteeism and 2) presenteeism and productivity losses related to 3) unpaid work.
- patient health status [ Time Frame: at 12 weeks ]quality of life measured with the five dimensional EuroQol questionnaire (EQ-5D-3L, five dimensions with each 3 levels: 1-no problems, 2-some problems, and 3-extreme problems).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03582293
|Contact: William P Vandertop, MD PhD||+31205669111 ext email@example.com|
|Contact: Dagmar Verbaan, PhDfirstname.lastname@example.org|
|Academic Medical Center||Recruiting|
|Amsterdam, Netherlands, 1100DD|
|Contact: William P Vandertop, MD, PhD +31205663316 email@example.com|
|Contact: D Verbaan +31205663316 firstname.lastname@example.org|
|Sub-Investigator: Steven Immenga|