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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
64
intravenous
intravenous
Stroke Center, University Hospital Basel
Basel, Switzerland
Hematoma expansion
Change in ICH-volume between baseline CT and follow-up-CT at 24 ± 3 hours of 33% relative or 6ml absolute increase
Time frame: up to 27 hours
modified Rankin Scale (mRS) 0-4 at month 3;
Time frame: 3 months
mRS 0-3 at month 3;
Time frame: 3 months
Categorical shift in mRS at month 3
Time frame: 3 months
mortality due to any cause at month 3
Time frame: 3 months
In-hospital mortality
Time frame: baseline until discharge from hospital (stay at hospital lasts on an average of 10 days)
Absolute ICH growth volume by 24 ± 3 hours, adjusted for baseline ICH volume
Time frame: up to 27 hours
Symptomatic HE defined as HE and additionally a neurological deterioration of NIHSS >4 points or Glasgow Coma Scale (GCS) >2 points
Time frame: up to 27 hours
number of major thromboembolic events (myocardial infarction, ischemic stroke, pulmonary embolism - safety endpoints)
Time frame: 3 months
number of neurosurgical interventions (including craniectomy, external ventricular drain (EVD), hematoma evacuation)
Time frame: 3 months
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