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

Intracerebral Hemorrhage Clinical Trial

— TICH-NOAC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02866838
• Other study ID #: BASEC 2016-01251
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: December 2016
• Est. completion date: March 22, 2022

Study information

• Verified date: March 2022
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: March 22, 2022
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage

Intervention

Drug:
• Tranexamic acid
intravenous
• Saline 0.9%
intravenous

Locations

Country	Name	City	State
Switzerland	Stroke Center, University Hospital Basel	Basel

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Swiss National Science Foundation

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hematoma expansion	Change in ICH-volume between baseline CT and follow-up-CT at 24 ± 3 hours of 33% relative or 6ml absolute increase	up to 27 hours
Secondary	modified Rankin Scale (mRS) 0-4 at month 3;		3 months
Secondary	mRS 0-3 at month 3;		3 months
Secondary	Categorical shift in mRS at month 3		3 months
Secondary	mortality due to any cause at month 3		3 months
Secondary	In-hospital mortality		baseline until discharge from hospital (stay at hospital lasts on an average of 10 days)
Secondary	Absolute ICH growth volume by 24 ± 3 hours, adjusted for baseline ICH volume		up to 27 hours
Secondary	Symptomatic HE defined as HE and additionally a neurological deterioration of NIHSS >4 points or Glasgow Coma Scale (GCS) >2 points		up to 27 hours
Secondary	number of major thromboembolic events (myocardial infarction, ischemic stroke, pulmonary embolism - safety endpoints)		3 months
Secondary	number of neurosurgical interventions (including craniectomy, external ventricular drain (EVD), hematoma evacuation)		3 months