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

Sponsor
University Hospital, Basel, Switzerland (Other)
Overall Status
Completed
CT.gov ID
NCT02866838
Collaborator
Swiss National Science Foundation (Other)
64
Enrollment
1
Location
2
Arms
63.6
Actual Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Tranexamic acid
  • Drug: Saline 0.9%
 Phase 2/Phase 3

Study Design

Study Type:
Interventional
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 :
Dec 1, 2016
Actual Primary Completion Date :
Sep 30, 2021
Actual Study Completion Date :
Mar 22, 2022

Arms and Interventions

Arm Intervention/Treatment
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.

Drug: Tranexamic acid
intravenous
Other Names:
  • Cyklokapron

    		•
    Placebo Comparator: Placebo

    Saline 0.9% given in identical dosage as experimental

    Drug: Saline 0.9%
    intravenous

    Outcome Measures

    Primary Outcome Measures

    1. Hematoma expansion [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

    Secondary Outcome Measures

    1. modified Rankin Scale (mRS) 0-4 at month 3; [3 months]

    2. mRS 0-3 at month 3; [3 months]

    3. Categorical shift in mRS at month 3 [3 months]

    4. mortality due to any cause at month 3 [3 months]

    5. In-hospital mortality [baseline until discharge from hospital (stay at hospital lasts on an average of 10 days)]

    6. Absolute ICH growth volume by 24 ± 3 hours, adjusted for baseline ICH volume [up to 27 hours]

    7. 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]

    8. number of major thromboembolic events (myocardial infarction, ischemic stroke, pulmonary embolism - safety endpoints) [3 months]

    9. number of neurosurgical interventions (including craniectomy, external ventricular drain (EVD), hematoma evacuation) [3 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Stroke Center, University Hospital Basel Basel Switzerland 4031

    Sponsors and Collaborators

    • University Hospital, Basel, Switzerland
    • Swiss National Science Foundation

    Investigators

    • Study Chair: Philippe Lyrer, MD, Stroke Center and Neurology, University Hospital Basel
    • Study Chair: Stefan Engelter, MD, Stroke Center and Neurology, University Hospital Basel

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Basel, Switzerland
    ClinicalTrials.gov Identifier:
    NCT02866838
    Other Study ID Numbers:
    • BASEC 2016-01251
    First Posted:
    Aug 15, 2016
    Last Update Posted:
    Apr 4, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Basel, Switzerland
    Tranexamic acid
    NOAC
    Direct Oral Anticoagulant (DOAC)
    Direct oral anticoagulants
    Non-Vitamin K antagonist oral anticoagulants
    Additional relevant MeSH terms:
    Cerebral Hemorrhage
    Hemorrhage
    Tranexamic Acid

    Study Results

    No Results Posted as of Apr 4, 2022