Tranexamic Acid to Prevent OpeRation in Chronic Subdural Hematoma. A Double-blind, Placebo-controlled, Multicentre, Randomized Controlled Clinical Trial

Who is this study for? Patients with Chronic Subdural Hematoma
What treatments are being studied? Tranexamic Acid
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

Objectives: Primarily to evaluate the efficacy of TXA to prevent surgery for cSDH. Secondarily to evaluate the efficacy of TXA to reduce cSDH volume, neurological impairment (mNIHSS), the incidence of falling incidents, the mortality rate, the use of care and health-related costs (iMCQ and iPCQ), to improve cognitive functioning (MOCA), performance in activities of daily living (Barthel and Lawton-Brody), functional outcome (mRS), the level of quality of life. Study design: Double-blind placebo-controlled multicentre randomized clinical trial. Study population: All patients, age 50 and above, diagnosed with cSDH for whom a conservative treatment is selected as primary treatment strategy. Intervention: The intervention group will receive oral TXA 500mg twice daily for 4 weeks, 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 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 4, 8and 12 weeks with a standard CT-scan of the head, outpatient clinic visits and 4 patient-reported questionnaires. These outpatient clinic visits are standard care; the third CT-scan, the questionnaires and extra clinical tests are extra. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

• On CT confirmed cSDH

• Primary conservative treatment, based on clinical symptoms: Glasgow Coma Scale score \>=14, mNIHSS score \<=4 and a stable neurological deficit (no new, or progression of, symptoms between the assessment by the neurologist and the assessment by the neurosurgeon).

Locations
Other Locations
Netherlands
Academic Medical Center
RECRUITING
Amsterdam
Contact Information
Primary
William P Vandertop, MD PhD
w.p.vandertop@amsterdamumc.nl
+31205669111
Backup
Dagmar Verbaan, PhD
d.verbaan@amsterdamumc.nl
+31205663316
Time Frame
Start Date: 2018-06-19
Estimated Completion Date: 2029-10-30
Participants
Target number of participants: 554
Treatments
Active_comparator: Tranexamic Acid
Tranexamic acid 500mg two times a day orally for a total of 28 days
Placebo_comparator: PLACEBO
Placebo capsules two times a day orally for a total of 28 days
Sponsors
Leads: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development

This content was sourced from clinicaltrials.gov

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