Tranexamic Acid to Prevent OpeRation in Chronic Subdural Hematoma
Status:
Recruiting
Trial end date:
2024-12-31
Target enrollment:
Participant gender:
Summary
Rationale: Chronic subdural hematoma (cSDH) is a frequently occurring disease, occurring
mainly in the elderly. Surgical evacuation is effective, but 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, 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.
Phase:
Phase 3
Details
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators:
Hersenstichting ZonMw: The Netherlands Organisation for Health Research and Development