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Intracerebral HemorrhagePhase 2/3TICH-NOACNCT02866838

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

A Phase 2/3 study testing Tranexamic acid and Saline 0.9% in people with Intracerebral Hemorrhage, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Intracerebral Hemorrhage
What is being tested?
Tranexamic acid and Saline 0.9%
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
64 participants
Where
1 siteSwitzerland
Study dates
Dec 2016to 22 Mar 2022
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Stroke Center, University Hospital Basel

    Basel, 4031

Other trials in Switzerland

About this study

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

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.

Being tested
Tranexamic acid, Saline 0.9%
Keywords
Tranexamic acid, NOAC, Direct Oral Anticoagulant (DOAC), Direct oral anticoagulants, Non-Vitamin K antagonist oral anticoagulants
Medical subject headings
Cerebral Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tranexamic acidDrug

    Also called Cyklokapron

    intravenous

  • Saline 0.9%Drug

    intravenous

Study groups in NCT02866838
Study groupRoleWhat they receive
Tranexamic acidExperimentalIntravenous tranexamic acid: 1g loading dose given as 100 mls infusion over 10 minutes, followed by another 1g in 250 mls infused over 8 hours.
Receives: Drug: Tranexamic acid
PlaceboPlacebo comparatorSaline 0.9% given in identical dosage as experimental
Receives: Drug: Saline 0.9%

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hematoma expansion

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

    Measured: up to 27 hours

Secondary outcomes (9)

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

    Measured: 3 months

  2. mRS 0-3 at month 3;

    Measured: 3 months

  3. Categorical shift in mRS at month 3

    Measured: 3 months

  4. mortality due to any cause at month 3

    Measured: 3 months

  5. In-hospital mortality

    Measured: 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

    Measured: 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

    Measured: up to 27 hours

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

    Measured: 3 months

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

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2016 (estimated)
  2. Study startDec 2016
  3. Primary completion30 Sep 2021
  4. Study completion22 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02866838
Sponsor's protocol ID
BASEC 2016-01251
Acronym
TICH-NOAC
Status last verified
Mar 2022
First submitted
10 Aug 2016
Last updated
4 Apr 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Siepen BM, Polymeris A, Shoamanesh A, Connolly S, Steiner T, Poli S, Lemmens R, Goeldlin MB, Muller M, Branca M, Rauch J, Meinel T, Kaesmacher J, Z'Graggen W, Arnold M, Fischer U, Peters N, Engelter ST, Lyrer P, Seiffge D. Andexanet alfa versus non-specific treatments for intracerebral hemorrhage in patients taking factor Xa inhibitors - Individual patient data analysis of ANNEXA-4 and TICH-NOAC. Int J Stroke. 2024 Jun;19(5):506-514. doi: 10.1177/17474930241230209. Epub 2024 Mar 8.

    PubMed 38264861

  • Eilertsen H, Menon CS, Law ZK, Chen C, Bath PM, Steiner T, Desborough MJ, Sandset EC, Sprigg N, Al-Shahi Salman R. Haemostatic therapies for stroke due to acute, spontaneous intracerebral haemorrhage. Cochrane Database Syst Rev. 2023 Oct 23;10(10):CD005951. doi: 10.1002/14651858.CD005951.pub5.

    PubMed 37870112

  • Polymeris AA, Karwacki GM, Siepen BM, Schaedelin S, Tsakiris DA, Stippich C, Guzman R, Nickel CH, Sprigg N, Kagi G, Vehoff J, Barinka F, Thilemann S, Maurer M, Wagner B, Traenka C, Gensicke H, De Marchis GM, Bonati LH, Fischer U, Z'Graggen WJ, Nedeltchev K, Wegener S, Baumgartner P, Engelter ST, Seiffge DJ, Peters N, Lyrer PA; TICH-NOAC Investigators. Tranexamic Acid for Intracerebral Hemorrhage in Patients on Non-Vitamin K Antagonist Oral Anticoagulants (TICH-NOAC): A Multicenter, Randomized, Placebo-Controlled, Phase 2 Trial. Stroke. 2023 Sep;54(9):2223-2234. doi: 10.1161/STROKEAHA.123.042866. Epub 2023 Jul 19.

    PubMed 37466000

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Tranexamic acid and Saline 0.9% in people with Intracerebral Hemorrhage, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hematoma expansion (time frame: up to 27 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02866838, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2022.

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