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Completed

NCT Number: NCT02866838

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

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.

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Key information

Conditions

Intracerebral Hemorrhage Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Hemorrhage Cerebrovascular Disorders Hemorrhage Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Stroke Center, University Hospital Basel

Basel, 4031, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tranexamic Acid

Drug

intravenous

Other names: Cyklokapron

saline 0.9%

Drug

intravenous

Primary outcomes

  1. 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

Secondary outcomes

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

    Time frame: 3 months

  2. mRS 0-3 at month 3;

    Time frame: 3 months

  3. Categorical shift in mRS at month 3

    Time frame: 3 months

  4. mortality due to any cause at month 3

    Time frame: 3 months

  5. In-hospital mortality

    Time frame: 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

    Time frame: 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

    Time frame: up to 27 hours

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

    Time frame: 3 months

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

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • Swiss National Science Foundation

Registry information

Official study title

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

Acronym: TICH-NOAC

Important dates

Study start
2016
Primary completion
2021
Study completion
2022
First posted
Aug 15, 2016
Registry last updated
Apr 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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