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Tranexamic Acid to Prevent Operation in Chronic Subdural Hematoma


- candidate number28017
- NTR NumberNTR6758
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-okt-2017
- Secondary IDs848081003 ZonMw
- Public TitleTranexamic Acid to Prevent Operation in Chronic Subdural Hematoma
- Scientific TitleTranexamic Acid to Prevent Operation in Chronic Subdural Hematoma
- ACRONYMTORCH
- hypothesisTranexamic acid reduces the necessity for surgery and increases quality of life.
- Healt Condition(s) or Problem(s) studiedChronic subdural hematoma, Tranexamic acid, Burr-hole drainage
- Inclusion criteria· Age 50 years and above;
· On CT and/or MRI confirmed cSDH (isodense or hypodense subdural collection, uni- or bilateral);
· 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;
· 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);
· Severe impairment of renal function (eGFR <30ml/min or serum creatinine >150µmol/L);
· Anaemia (haemoglobin <6g/dl);
· History of convulsions;
· Pregnancy (checked with a pregnancy test only in women in their childbearing period) or breastfeeding;
· Inability to obtain informed consent from the patient or legal representative (including language barrier);
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 28-mrt-2017
- planned closingdate28-mrt-2020
- Target number of participants140
- InterventionsOral tranexamic acid 500mg two times a day for a total of 28 days
- Primary outcome1. Number of patients requiring surgery for cSDH within 12 weeks;
2. Quality of life at 12 weeks, measured with the Short Form Health Survey (SF-36) questionnaire.
- Secondary outcome1. Functional outcome at four, eight and 12 weeks, measured with the modified Rankin Scale (mRS) score;
2. Neurological impairment at four, eight and 12 weeks, measured with the modified National Institutes of Health Stroke Scale (mNIHSS) score;
3. Quality of life at four and eight weeks, measured with the Short Form Health Survey (SF-36) questionnaire;
4. Performance in activities of daily living at four, eight and 12 weeks, measured with the Barthel Index scale and the Lawton-Brody scale;
5. Cognitive functioning at four, eight and 12 weeks, measured with the Montreal Cognitive Assessment (MOCA) test;
6. Quality of life at 12 weeks, measured with the five dimensional EuroQol (EQ-5D) questionnaire;
7. Volume and percentage of volume reduction of cSDH at four, eight and 12 weeks on follow-up CT scan of the head;
8. Mortality at four, eight and 12 weeks;
9. Health care costs at four, eight and 12 weeks.
10. Occurrence of thromboembolic complications at two, four, eight and 12 weeks (definitie);
- TimepointsAt four, eight and twelve weeks
- Trial web sitehttp://www.torchstudie.nl
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD S. Immenga
- CONTACT for SCIENTIFIC QUERIESMD S. Immenga
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
ZonMw
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD14-okt-2017 - 11-nov-2017


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