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

Primary Purpose

Intracerebral Hemorrhage

Status

Completed

Phase

Phase 2

Locations

Switzerland

Study Type

Interventional

Intervention

Tranexamic acid

Saline 0.9%

About this trial

This is an interventional treatment trial for Intracerebral Hemorrhage focused on measuring Tranexamic acid, NOAC, Direct Oral Anticoagulant (DOAC), Direct oral anticoagulants, Non-Vitamin K antagonist oral anticoagulants

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Stroke Center, University Hospital Basel

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tranexamic acid

Placebo

Arm Description

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.

Saline 0.9% given in identical dosage as experimental

Outcomes

Primary Outcome Measures

Hematoma expansion

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

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

mRS 0-3 at month 3;

Categorical shift in mRS at month 3

mortality due to any cause at month 3

In-hospital mortality

Absolute ICH growth volume by 24 ± 3 hours, adjusted for baseline ICH volume

Symptomatic HE defined as HE and additionally a neurological deterioration of NIHSS >4 points or Glasgow Coma Scale (GCS) >2 points

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

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

Full Information

NCT ID

NCT02866838

First Posted

August 10, 2016

Last Updated

March 22, 2022

Sponsor

University Hospital, Basel, Switzerland

Collaborators

Swiss National Science Foundation

1. Study Identification

Unique Protocol Identification Number

NCT02866838

Brief Title

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

Acronym

TICH-NOAC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

December 2016 (Actual)

Primary Completion Date

September 30, 2021 (Actual)

Study Completion Date

March 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Basel, Switzerland

Collaborators

Swiss National Science Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Intracerebral Hemorrhage

Keywords

Tranexamic acid, NOAC, Direct Oral Anticoagulant (DOAC), Direct oral anticoagulants, Non-Vitamin K antagonist oral anticoagulants

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

64 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tranexamic acid

Arm Type

Experimental

Arm Description

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.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Saline 0.9% given in identical dosage as experimental

Intervention Type

Drug

Intervention Name(s)

Tranexamic acid

Other Intervention Name(s)

Cyklokapron

Intervention Description

intravenous

Intervention Type

Drug

Intervention Name(s)

Saline 0.9%

Intervention Description

intravenous

Primary Outcome Measure Information:

Title

Hematoma expansion

Description

Change in ICH-volume between baseline CT and follow-up-CT at 24 ± 3 hours of 33% relative or 6ml absolute increase

Time Frame

up to 27 hours

Secondary Outcome Measure Information:

Title

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

Time Frame

3 months

Title

mRS 0-3 at month 3;

Time Frame

3 months

Title

Categorical shift in mRS at month 3

Time Frame

3 months

Title

mortality due to any cause at month 3

Time Frame

3 months

Title

In-hospital mortality

Time Frame

baseline until discharge from hospital (stay at hospital lasts on an average of 10 days)

Title

Absolute ICH growth volume by 24 ± 3 hours, adjusted for baseline ICH volume

Time Frame

up to 27 hours

Title

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

Title

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

Time Frame

3 months

Title

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

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Philippe Lyrer, MD

Organizational Affiliation

Stroke Center and Neurology, University Hospital Basel

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Stefan Engelter, MD

Organizational Affiliation

Stroke Center and Neurology, University Hospital Basel

Official's Role

Study Chair

Facility Information:

Facility Name

Stroke Center, University Hospital Basel

City

Basel

ZIP/Postal Code

4031

Country

Switzerland

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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