Clinical trial NCT02866838: Treatment of Intracerebral Hemorrhage in Patients on Non-vitamin K Antagonist
Official title: Treatment of Intracerebral Hemorrhage in Patients on Non-vitamin K Antagonist Oral Anticoagulants (NOAC) With Tranexamic Acid
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Intracerebral Hemorrhage
Keywords: Tranexamic acid
NOAC
Direct Oral Anticoagulant (DOAC)
Direct oral anticoagulants
Non-Vitamin K antagonist oral anticoagulants
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
First posted: 2016-08-15
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Hematoma expansion
timeFrame: up to 27 hours
Secondary outcomes:
measure: modified Rankin Scale (mRS) 0-4 at month 3;
timeFrame: 3 months
measure: mRS 0-3 at month 3;
timeFrame: 3 months
measure: Categorical shift in mRS at month 3
timeFrame: 3 months
measure: mortality due to any cause at month 3
timeFrame: 3 months
measure: In-hospital mortality
timeFrame: baseline until discharge from hospital (stay at hospital lasts on an average of 10 days)
measure: Absolute ICH growth volume by 24 ± 3 hours, adjusted for baseline ICH volume
timeFrame: up to 27 hours
measure: Symptomatic HE defined as HE and additionally a neurological deterioration of NIHSS >4 points or Glasgow Coma Scale (GCS) >2 points
timeFrame: up to 27 hours
measure: number of major thromboembolic events (myocardial infarction, ischemic stroke, pulmonary embolism - safety endpoints)
timeFrame: 3 months
measure: number of neurosurgical interventions (including craniectomy, external ventricular drain (EVD), hematoma evacuation)
timeFrame: 3 months
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Stroke Center, University Hospital Basel
Study officials:
affiliation: Stroke Center and Neurology, University Hospital Basel
name: Philippe Lyrer, MD
role: STUDY_CHAIR
affiliation: Stroke Center and Neurology, University Hospital Basel
name: Stefan Engelter, MD
role: STUDY_CHAIR
References: