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

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ClinicalTrials.gov Identifier: NCT02866838
Recruitment Status : Recruiting
First Posted : August 15, 2016
Last Update Posted : February 22, 2019
Sponsor:
Collaborator:
Swiss National Science Foundation
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

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
Intracerebral Hemorrhage Drug: Tranexamic acid Drug: Saline 0.9% Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 109 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
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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 Name: Cyklokapron

Placebo Comparator: Placebo
Saline 0.9% given in identical dosage as experimental
Drug: Saline 0.9%
intravenous




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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

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.

Information from the National Library of Medicine

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


Contacts
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Contact: David Seiffge, MD 0041-61-32 87278 david.seiffge@usb.ch
Contact: Marina Maurer 0041-61-2565030 marina.maurer@usb.ch

Locations
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Switzerland
Stroke Center, University Hospital Basel Recruiting
Basel, Switzerland, 4031
Contact: Marina Maurer    0041-61-2565030    marina.maurer@usb.ch   
Contact: Nils Peters, MD       nils.peters@usb.ch   
Principal Investigator: Nils Peters, MD         
Principal Investigator: David Seiffge, MD         
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Swiss National Science Foundation
Investigators
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Study Chair: Philippe Lyrer, MD Stroke Center and Neurology, University Hospital Basel
Study Chair: Stefan Engelter, MD Stroke Center and Neurology, University Hospital Basel

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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT02866838     History of Changes
Other Study ID Numbers: BASEC 2016-01251
First Posted: August 15, 2016    Key Record Dates
Last Update Posted: February 22, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
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Hemorrhage
Cerebral Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Tranexamic Acid
Anticoagulants
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants