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

Last updated: March 22, 2022
Sponsor: University Hospital, Basel, Switzerland
Overall Status: Completed

Phase

2/3

Condition

Stroke

Hemorrhage

Brain Injury

Treatment

N/A

Clinical Study ID

NCT02866838
BASEC 2016-01251
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • Acute intracerebral hemorrhage (symptom onset <12h)
  • Prior treatment with a novel direct oral anticoagulant (apixaban, dabigatran, edoxabanor rivaroxaban; last intake <48hours or proven NOAC activity by relevant coagulationassays)
  • Age >18 years, No upper age limit
  • Informed consent has been received in accordance to local ethics committeerequirements

Exclusion

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 structuralabnormality prior to enrolment, but where an underlying structural abnormality isalready 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.

Study Design

Total Participants: 64
Study Start date:
December 01, 2016
Estimated Completion Date:
March 22, 2022

Connect with a study center

  • Stroke Center, University Hospital Basel

    Basel, 4031
    Switzerland

    Site Not Available

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