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

  • End date
    Dec 25, 2022
  • participants needed
  • sponsor
    University Hospital, Basel, Switzerland
Updated on 25 January 2021


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.

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


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
Planned neurosurgical hematoma evacuation within 24 hours (before follow-up imaging)
Pulmonary embolism/deep vein thrombosis within the last 2 weeks
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Phone Email

Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note