Treatment of Intracerebral Hemorrhage in Patients on Non-vitamin K Antagonist (TICH-NOAC)

University Hospital Basel

Status and phase: Completed; Phase 3; Phase 2

Conditions: Intracerebral Hemorrhage

Treatments: Drug: Tranexamic acid; Drug: Saline 0.9%

Study type: Interventional

Funder types: Other

Identifiers

NCT02866838

BASEC 2016-01251

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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64 participants in 2 patient groups, including a placebo group

Tranexamic acid

Experimental group

Description:

Intravenous tranexamic acid: 1g loading dose given as 100 mls infusion over 10 minutes, followed by another 1g in 250 mls infused over 8 hours.

Treatment:

Drug: Tranexamic acid

Placebo

Placebo Comparator group

Description:

Saline 0.9% given in identical dosage as experimental

Treatment:

Drug: Saline 0.9%