NCT02866838

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

Treatment of Intracerebral Hemorrhage in Patients on Non-vitamin K Antagonist Oral Anticoagulants (NOAC) With Tranexamic Acid

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: University Hospital, Basel, Switzerland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intracerebral Hemorrhage

Interventions

Type	Name	Description
DRUG	Tranexamic acid	intravenous
DRUG	Saline 0.9%	intravenous

Timeline

• Start date: 2016-12-01
• Primary completion: 2021-09-30
• Completion: 2022-03-22
• First posted: 2016-08-15
• Last updated: 2022-04-04

Locations

1 site across 1 country: Switzerland