Treatment of Intracerebral Hemorrhage in Patients on Non-vitamin K Antagonist (TICH-NOAC)
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ClinicalTrials.gov Identifier: NCT02866838 |
Recruitment Status :
Completed
First Posted : August 15, 2016
Last Update Posted : April 4, 2022
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Intracerebral Hemorrhage | Drug: Tranexamic acid Drug: Saline 0.9% | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 64 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Treatment of Intracerebral Hemorrhage in Patients on Non-vitamin K Antagonist Oral Anticoagulants (NOAC) With Tranexamic Acid |
Actual Study Start Date : | December 2016 |
Actual Primary Completion Date : | September 30, 2021 |
Actual Study Completion Date : | March 22, 2022 |

Arm | Intervention/treatment |
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Experimental: Tranexamic acid
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.
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Drug: Tranexamic acid
intravenous
Other Name: Cyklokapron |
Placebo Comparator: Placebo
Saline 0.9% given in identical dosage as experimental
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Drug: Saline 0.9%
intravenous |
- Hematoma expansion [ Time Frame: up to 27 hours ]Change in ICH-volume between baseline CT and follow-up-CT at 24 ± 3 hours of 33% relative or 6ml absolute increase
- modified Rankin Scale (mRS) 0-4 at month 3; [ Time Frame: 3 months ]
- mRS 0-3 at month 3; [ Time Frame: 3 months ]
- Categorical shift in mRS at month 3 [ Time Frame: 3 months ]
- mortality due to any cause at month 3 [ Time Frame: 3 months ]
- In-hospital mortality [ Time Frame: baseline until discharge from hospital (stay at hospital lasts on an average of 10 days) ]
- Absolute ICH growth volume by 24 ± 3 hours, adjusted for baseline ICH volume [ Time Frame: up to 27 hours ]
- Symptomatic HE defined as HE and additionally a neurological deterioration of NIHSS >4 points or Glasgow Coma Scale (GCS) >2 points [ Time Frame: up to 27 hours ]
- number of major thromboembolic events (myocardial infarction, ischemic stroke, pulmonary embolism - safety endpoints) [ Time Frame: 3 months ]
- number of neurosurgical interventions (including craniectomy, external ventricular drain (EVD), hematoma evacuation) [ Time Frame: 3 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02866838
Switzerland | |
Stroke Center, University Hospital Basel | |
Basel, Switzerland, 4031 |
Study Chair: | Philippe Lyrer, MD | Stroke Center and Neurology, University Hospital Basel | |
Study Chair: | Stefan Engelter, MD | Stroke Center and Neurology, University Hospital Basel |
Documents provided by University Hospital, Basel, Switzerland:
Responsible Party: | University Hospital, Basel, Switzerland |
ClinicalTrials.gov Identifier: | NCT02866838 |
Other Study ID Numbers: |
BASEC 2016-01251 |
First Posted: | August 15, 2016 Key Record Dates |
Last Update Posted: | April 4, 2022 |
Last Verified: | March 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Tranexamic acid NOAC Direct Oral Anticoagulant (DOAC) Direct oral anticoagulants Non-Vitamin K antagonist oral anticoagulants |
Cerebral Hemorrhage Hemorrhage Pathologic Processes Intracranial Hemorrhages Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Vascular Diseases Cardiovascular Diseases Tranexamic Acid Antifibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Hemostatics Coagulants |