Treatment of Intracerebral Hemorrhage in Patients on Non-vitamin K Antagonist

  • STATUS
    Recruiting
  • End date
    Dec 25, 2022
  • participants needed
    109
  • sponsor
    University Hospital, Basel, Switzerland
Updated on 25 January 2021
anticoagulants
rivaroxaban
noac
hematoma
apixaban

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.

Details
Condition Cerebral Hemorrhage, intracerebral hemorrhage, intracerebral haemorrhage, hemorrhage cerebral, intracerebral hemorrhage (ich), cerebral bleeding
Treatment Tranexamic Acid, Saline 0.9%
Clinical Study IdentifierNCT02866838
SponsorUniversity Hospital, Basel, Switzerland
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Cerebral Hemorrhage?
Do you have any of these conditions: intracerebral hemorrhage (ich) or intracerebral haemorrhage or hemorrhage cerebral or cerebral bleeding or intracerebral hemorrhage or Cerebral Hemorr...?
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
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