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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

Tracking Information
First Submitted Date  ICMJE August 10, 2016
First Posted Date  ICMJE August 15, 2016
Last Update Posted Date February 22, 2019
Actual Study Start Date  ICMJE December 2016
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 10, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02866838 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2016)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Intracerebral Hemorrhage in Patients on Non-vitamin K Antagonist
Official Title  ICMJE Treatment of Intracerebral Hemorrhage in Patients on Non-vitamin K Antagonist Oral Anticoagulants (NOAC) With Tranexamic Acid
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Intracerebral Hemorrhage
Intervention  ICMJE
  • Drug: Tranexamic acid
    intravenous
    Other Name: Cyklokapron
  • Drug: Saline 0.9%
    intravenous
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Tranexamic acid
  • Placebo Comparator: Placebo
    Saline 0.9% given in identical dosage as experimental
    Intervention: Drug: Saline 0.9%
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 10, 2016)
109
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: David Seiffge, MD 0041-61-32 87278 david.seiffge@usb.ch
Contact: Marina Maurer 0041-61-2565030 marina.maurer@usb.ch
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02866838
Other Study ID Numbers  ICMJE BASEC 2016-01251
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party University Hospital, Basel, Switzerland
Study Sponsor  ICMJE University Hospital, Basel, Switzerland
Collaborators  ICMJE Swiss National Science Foundation
Investigators  ICMJE
Study Chair: Philippe Lyrer, MD Stroke Center and Neurology, University Hospital Basel
Study Chair: Stefan Engelter, MD Stroke Center and Neurology, University Hospital Basel
PRS Account University Hospital, Basel, Switzerland
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP