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Intracerebral HaemorrhagePhase 2STOP-AUSTNCT01702636

STOP-AUST: The Spot Sign and Tranexamic Acid On Preventing ICH Growth - AUStralasia Trial

A Phase 2 study testing Tranexamic Acid in people with Intracerebral Haemorrhage and Stroke, run by Neuroscience Trials Australia at 11 sites in 2 countries.

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

The aim of the study is to test if intracerebral haemorrhage (ICH) patients who have contrast extravasation on computed tomography angiography, the "spot sign", have lower rates of haematoma growth when treated with tranexamic acid within 4.5 hours of stroke onset, compared to placebo. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Intracerebral Haemorrhage, Stroke
What is being tested?
Tranexamic Acid
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
11 sitesin 2 countries
Study dates
Dec 2012to Dec 2019
Phase
Phase 2
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

  • Patients presenting with an acute ICH
  • Contrast extravasation within the haemorrhage, "spot sign", evaluated from the CTA according to three criteria, all of which must be present:
  • Serpiginous or spot-like appearance within the margin of a parenchymal haematoma without connection to an outside vessel;
  • The density (in Hounsfield units) should be greater than that of the background haematoma (site investigators are not required to document the density); and
  • No hyperdensity at the corresponding location on non-contrast CT.
  • Age ≥18 years
  • Treatment can commence within 1 hour of initial CT and within 4.5 hours of symptom onset (or in patients with unknown time of symptom onset, the time patient was last known to be well)
  • Informed consent has been received in accordance to local ethics committee requirements

Who cannot join

  • Glasgow coma scale (GCS) total score of <8
  • Brainstem ICH
  • ICH volume >70 ml as measured by the ABC/2 method
  • ICH known or suspected by study investigator to be secondary to trauma, aneurysm, vascular malformation, haemorrhagic transformation of ischaemic stroke, cerebral venous thrombosis, thrombolytic therapy, tumor, or infection
  • Contrast already administered within 24 hours prior to initial CT or contraindication to imaging with CT contrast agents (e.g. known or suspected iodine allergy or significant renal failure)
  • Any history or current evidence suggestive of venous or arterial thrombotic events within the previous 12 months, including clinical, ECG, laboratory, or imaging findings. Clinically silent chance findings of old ischemia are not considered exclusion.
Show all 14Show fewer
  • Hereditary or acquired haemorrhagic diathesis or coagulation factor deficiency.
  • Use of heparin, low-molecular weight heparin, GPIIb/IIIa antagonist, or oral anticoagulation (e.g. warfarin, factor Xa inhibitor, thrombin inhibitor) within the previous 14 days, irrespective of laboratory values
  • Pregnancy (women of childbearing potential must be tested)
  • Planned surgery for ICH within 24 hours
  • Concurrent or planned treatment with haemostatic agents (e.g. prothrombin complex concentrate, vitamin K, fresh frozen plasma, or platelet transfusion)
  • Participation in any investigational study in the last 30 days
  • Known terminal illness or planned withdrawal of care or comfort care measures.
  • Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.

Trial locations and contacts

11 sites in 2 countries.

11 sites in 2 countries

Australia10 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Box Hill Hospital

    Box Hill, Victoria, 3128

  • Western Hospital

    Footscray, Victoria, 3011

  • Frankston Hospital

    Frankston, Victoria, 3199

  • Gosford Hospital

    Kanwal, New South Wales, 2259

  • The Royal Melbourne Hospital

    Melbourne, Victoria, 3050

  • John Hunter Hospital

    Newcastle, New South Wales, 2310

  • St. Vincent's Hospital

    Sydney, New South Wales, 2010

  • Royal Prince Alfred Hospital

    Sydney, New South Wales, 2050

  • Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

Finland1 site

  • Helsinki University Central Hospital

    Helsinki

Other trials in Finland

About this study

Official title: STOP-AUST: The Spot Sign and Tranexamic Acid On Preventing ICH Growth - AUStralasia Trial.

The aim of the study is to test if intracerebral haemorrhage (ICH) patients who have contrast extravasation on computed tomography angiography, the "spot sign", have lower rates of haematoma growth when treated with tranexamic acid within 4.5 hours of stroke onset, compared to placebo.

Being tested
Tranexamic Acid, Placebo
Keywords
Intracerebral Hemorrhage, ICH, Stroke, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Vascular Diseases, Cardiovascular Diseases, Tranexamic Acid, Antifibrinolytic Agents, Fibrin Modulating Agents, Pharmacologic Actions, Cardiovascular Agents, Therapeutic Uses, Hematologic Agents, Hemostatics, Contrast Media, Angiography, Cerebral Angiography
Medical subject headings
Cerebral Hemorrhage, Stroke, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Vascular Diseases, Cardiovascular Diseases

What participants receive

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

Study groups in NCT01702636
Study groupRoleWhat they receive
Tranexamic AcidActive comparatorIntravenous tranexamic acid 1000 mg in 100 mL 0.9% NaCl over 10 minutes followed by 1000 mg in 500 mL 0.9% NaCl infusion over 8 hours.
Receives: Drug: Tranexamic Acid
PlaceboPlacebo comparatorIntravenous placebo in 100 mL 0.9% NaCl over 10 minutes followed by 500 mL 0.9% NaCl infusion over 8 hours.
Receives: Drug: Placebo

What is being measured

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

  1. ICH growth by 24±3 hours as defined by either 33% or 6 ml increase from baseline, adjusted for baseline ICH volume.

    Measured: 24+/-3 hours

Secondary outcomes (7)

  1. Major thromboembolic events (myocardial infarction, ischaemic stroke, pulmonary embolism)

    Measured: Within 90+/-7 days

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

    Measured: 24+/-3 hours

  3. Absolute intraventricular haematoma (IVH) growth volume by 24±3 hours, adjusted for baseline IVH volume

    Measured: 24+/-3 hours

  4. modified Rankin Scale (mRS) score of 0-4 at 3 months

    Measured: 90+/-7 days

  5. modified Rankin Scale (mRS) score of 0-3 at 3 months

    Measured: 90+/-7 days

  6. Categorical shift in mRS at 3 months, subject to the validity of proportional odds assumption

    Measured: 90+/-7 days

  7. Death due to any cause by 3 months

    Measured: within 90+/-7 days

Timeline

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

  1. First posted8 Oct 2012 (estimated)
  2. Study startDec 2012
  3. Primary completion14 Aug 2019
  4. Study completionDec 2019

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
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01702636
Sponsor's protocol ID
NTA1201
Acronym
STOP-AUST
Status last verified
Feb 2020
First submitted
3 Oct 2012
Last updated
26 Feb 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • 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

  • Yogendrakumar V, Wu TY, Churilov L, Tatlisumak T, Strbian D, Jeng JS, Kleinig TJ, Sharma G, Campbell BC, Zhao H, Hsu CY, Meretoja A, Donnan GA, Davis SM, Yassi N. Does tranexamic acid affect intraventricular hemorrhage growth in acute ICH? An analysis of the STOP-AUST trial. Eur Stroke J. 2022 Mar;7(1):15-19. doi: 10.1177/23969873211072402. Epub 2022 Feb 1.

    PubMed 35300248

  • Meretoja A, Yassi N, Wu TY, Churilov L, Sibolt G, Jeng JS, Kleinig T, Spratt NJ, Thijs V, Wijeratne T, Cho DY, Shah D, Cloud GC, Phan T, Bladin C, Moey A, Aviv RI, Barras CD, Sharma G, Hsu CY, Ma H, Campbell BCV, Mitchell P, Yan B, Parsons MW, Tiainen M, Curtze S, Strbian D, Tang SC, Harvey J, Levi C, Donnan GA, Davis SM. Tranexamic acid in patients with intracerebral haemorrhage (STOP-AUST): a multicentre, randomised, placebo-controlled, phase 2 trial. Lancet Neurol. 2020 Dec;19(12):980-987. doi: 10.1016/S1474-4422(20)30369-0. Epub 2020 Oct 28.

    PubMed 33128912

  • Meretoja A, Churilov L, Campbell BC, Aviv RI, Yassi N, Barras C, Mitchell P, Yan B, Nandurkar H, Bladin C, Wijeratne T, Spratt NJ, Jannes J, Sturm J, Rupasinghe J, Zavala J, Lee A, Kleinig T, Markus R, Delcourt C, Mahant N, Parsons MW, Levi C, Anderson CS, Donnan GA, Davis SM. The spot sign and tranexamic acid on preventing ICH growth--AUStralasia Trial (STOP-AUST): protocol of a phase II randomized, placebo-controlled, double-blind, multicenter trial. Int J Stroke. 2014 Jun;9(4):519-24. doi: 10.1111/ijs.12132. Epub 2013 Aug 26.

    PubMed 23981692

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tranexamic Acid in people with Intracerebral Haemorrhage and Stroke, run by Neuroscience Trials Australia at 11 sites in 2 countries.

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 8 inclusion and 14 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 26 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Australia, Finland. 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 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.

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?

ICH growth by 24±3 hours as defined by either 33% or 6 ml increase from baseline, adjusted for baseline ICH volume. (time frame: 24+/-3 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 NCT01702636, which also lists 4 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 26 Feb 2020.

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