Intracerebral Hemorrhage
Conditions
Keywords
Tranexamic acid, NOAC, Direct Oral Anticoagulant (DOAC), Direct oral anticoagulants, Non-Vitamin K antagonist oral anticoagulants
Brief summary
Novel, non-vitamin K antagonist oral anticoagulants (NOAC) target selected players in the coagulation cascade as the direct thrombin inhibitor dabigatran and the factor Xa-inhibitors apixaban and rivaroxaban. Intracerebral hemorrhage (ICH) is the most feared complication of NOAC treatment (NOAC-ICH). Outcome of NOAC-ICH can be devastating and is a major cause of death and disability. There is no proven treatment for NOAC-ICH. Hematoma expansion (HE) is associated with unfavorable outcome. Tranexamic acid (TA) is an anti-fibrinolytic drug that is used in a number of bleeding conditions other than ICH.
Interventions
DRUGTranexamic acid
intravenous
DRUGSaline 0.9%
intravenous
Sponsors
Swiss National Science Foundation
University Hospital, Basel, Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Acute intracerebral hemorrhage (symptom onset \<12h) * Prior treatment with a novel direct oral anticoagulant (apixaban, dabigatran, edoxaban or rivaroxaban; last intake \<48hours or proven NOAC activity by relevant coagulation assays) * Age \>18 years, No upper age limit * Informed consent has been received in accordance to local ethics committee requirements
Exclusion criteria
* Severe pre-morbid disability (modified Rankin scale \>4) * Anticoagulation with Vitamin K antagonists (VKA) (recent intake) * Secondary intracerebral hemorrhage (e.g. arteriovenous malformation (AVM), tumor, trauma) Note it is not necessary for investigators to exclude underlying structural abnormality prior to enrolment, but where an underlying structural abnormality is already known, these patients should not be recruited. * Glasgow coma scale \<5 * pregnancy * Planned neurosurgical hematoma evacuation within 24 hours (before follow-up imaging) * Pulmonary embolism/deep vein thrombosis within the last 2 weeks.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hematoma expansion | up to 27 hours | Change in ICH-volume between baseline CT and follow-up-CT at 24 ± 3 hours of 33% relative or 6ml absolute increase |
Secondary
| Measure | Time frame |
|---|---|
| mRS 0-3 at month 3; | 3 months |
| Categorical shift in mRS at month 3 | 3 months |
| mortality due to any cause at month 3 | 3 months |
| In-hospital mortality | baseline until discharge from hospital (stay at hospital lasts on an average of 10 days) |
| modified Rankin Scale (mRS) 0-4 at month 3; | 3 months |
| Symptomatic HE defined as HE and additionally a neurological deterioration of NIHSS >4 points or Glasgow Coma Scale (GCS) >2 points | up to 27 hours |
| number of major thromboembolic events (myocardial infarction, ischemic stroke, pulmonary embolism - safety endpoints) | 3 months |
| number of neurosurgical interventions (including craniectomy, external ventricular drain (EVD), hematoma evacuation) | 3 months |
| Absolute ICH growth volume by 24 ± 3 hours, adjusted for baseline ICH volume | up to 27 hours |
Countries
Switzerland
Outcome results
None listed