This study has been transitioned to CTIS with ID 2024-514927-40-02 check the CTIS register for the current data. To evaluate the efficacy of TXA to prevent surgery for cSDH
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
- Nervous system, skull and spine therapeutic procedures
- Vascular haemorrhagic disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Necessity for surgery after 12 weeks
Secondary outcome
Functional outcome (mRS), neurological impairment (mNIHSS), performance in
activities of daily living (Barthel and Lawton-Brody), cognitive functioning
(MOCA), quality of life (SF-36 and EQ-5D), cSDH volume, incidence of falling,
mortality rate and health care costs.
Background summary
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 a recent large
series of surgically treated patients, symptomatic recurrence was 9%, mortality
2% and unfavourable outcome 22%. Methods to prevent a surgical treatment are
therefore required. 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
prospective study aims to prove its efficacy in a randomised and
placebo-controlled trial.
Study objective
This study has been transitioned to CTIS with ID 2024-514927-40-02 check the CTIS register for the current data.
To evaluate the efficacy of TXA to prevent surgery for cSDH
Study design
Double-blind, placebo-controlled, multicentre, randomized clinical trial.
Intervention
During four weeks, the intervention group will receive oral TXA twice daily
500mg, the control group receives a placebo twice daily. The TXA or placebo
treatment is additional to standard care.
Study burden and risks
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, four
questionnaires and outpatient clinic visits. These outpatient clinic visits are
standard care; one CT-scan, the questionnaires and extra clinical tests during
the visit are extra for this study. Each patient may benefit from the study if
the study medication is indeed effective in preventing surgery for cSDH. Each
patient is also at risk since he or she is exposed to the potential side
effects of the medication. The potential benefit, namely the prevention of a
surgical treatment, outweighs the burden and risk of the temporary use of the
study medication and its potential side effects as TXA is considered to be a
very safe drug (e.g. the risk of thromboembolic events is only 0.01-0.1%).
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
• Age 50 years and above;
• 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).
Exclusion criteria
• Primary surgical treatment based on one or more of the following symptoms or
parameters: medically intractable headache, midline shift >10mm, imminent death
within 24 hours;
• Structural causes for subdural haemorrhage, e.g. arachnoid cysts, cortical
vascular malformations and a history of cranial surgery <1year;
• Aneurysmal subarachnoid haemorrhage;
• Active treatment for deep vein thrombosis, pulmonary embolism or cerebral
thrombosis (secondary prophylaxis is not considered to be active treatment);
• Active intravascular clotting or disseminated intravascular coagulation;
• Known hypersensitivity or allergy to TXA or to any of the ingredients;
• History of a blood coagulation disorder (hypercoagulability disorder);
• History of severe impairment of renal function (eGFR <30ml/min or serum
creatinine >150µmol/L);
• Amanesis with signs of anemia (fatigue, headache, exercise intolerance,
weakness and pallor (conjunctival) dry skin);
• History of epilepsy;
• History of inability to safely swallow oral medication;
• Inability to obtain informed consent from the patient or legal
representative, including language barrier.
Design
Recruitment
Medical products/devices used
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EU-CTR | CTIS2024-514927-40-02 |
| EudraCT | EUCTR2017-004311-40-NL |
| CCMO | NL63794.018.18 |