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

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ClinicalTrials.gov Identifier: NCT01702636
Recruitment Status : Active, not recruiting
First Posted : October 8, 2012
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
Neuroscience Trials Australia

Brief 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.

Condition or disease Intervention/treatment Phase
Intracerebral Haemorrhage Stroke Drug: Tranexamic Acid Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: STOP-AUST: The Spot Sign and Tranexamic Acid On Preventing ICH Growth - AUStralasia Trial.
Actual Study Start Date : December 2012
Actual Primary Completion Date : August 14, 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding Rashes

Arm Intervention/treatment
Active Comparator: Tranexamic Acid
Intravenous 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.
Drug: Tranexamic Acid
Placebo Comparator: Placebo
Intravenous placebo in 100 mL 0.9% NaCl over 10 minutes followed by 500 mL 0.9% NaCl infusion over 8 hours.
Drug: Placebo



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Major thromboembolic events (myocardial infarction, ischaemic stroke, pulmonary embolism) [ Time Frame: Within 90+/-7 days ]
  2. Absolute ICH growth volume by 24±3 hours, adjusted for baseline ICH volume [ Time Frame: 24+/-3 hours ]
  3. Absolute intraventricular haematoma (IVH) growth volume by 24±3 hours, adjusted for baseline IVH volume [ Time Frame: 24+/-3 hours ]
  4. modified Rankin Scale (mRS) score of 0-4 at 3 months [ Time Frame: 90+/-7 days ]
  5. modified Rankin Scale (mRS) score of 0-3 at 3 months [ Time Frame: 90+/-7 days ]
  6. Categorical shift in mRS at 3 months, subject to the validity of proportional odds assumption [ Time Frame: 90+/-7 days ]
  7. Death due to any cause by 3 months [ Time Frame: within 90+/-7 days ]

Other Outcome Measures:
  1. ICH growth [ Time Frame: 24+/-3 hours ]
    Exploratory analyses will be run with adjustments for baseline variables such as age, Glasgow Coma Scale (GCS), presence of IVH, and ICH location, and in the following subgroups: onset-to-treatment time (<3 vs. >3 hours); baseline ICH volume (<30 vs. >30 ml); anatomical location (deep, lobar, or cerebellar); IVH (absent vs. present); GCS (>12 vs. 8-12) and age (<70 vs. >70). These analyses will be hypothesis generating, as the trial is not powered for them.

  2. modified Rankin Scale (mRS) [ Time Frame: 90+/-7 days ]
    Exploratory analyses will be run with adjustments for baseline variables such as age, Glasgow Coma Scale (GCS), presence of IVH, and ICH location, and in the following subgroups: onset-to-treatment time (<3 vs. >3 hours); baseline ICH volume (<30 vs. >30 ml); anatomical location (deep, lobar, or cerebellar); IVH (absent vs. present); GCS (>12 vs. 8-12) and age (<70 vs. >70). These analyses will be hypothesis generating, as the trial is not powered for them.



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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:

  • 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:

    1. Serpiginous or spot-like appearance within the margin of a parenchymal haematoma without connection to an outside vessel;
    2. The density (in Hounsfield units) should be greater than that of the background haematoma (site investigators are not required to document the density); and
    3. 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

Exclusion Criteria:

  • 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.
  • 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.

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): NCT01702636


Locations
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Australia, New South Wales
Gosford Hospital
Kanwal, New South Wales, Australia, 2259
John Hunter Hospital
Newcastle, New South Wales, Australia, 2310
St. Vincent's Hospital
Sydney, New South Wales, Australia, 2010
Royal Prince Alfred Hospital
Sydney, New South Wales, Australia, 2050
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Box Hill Hospital
Box Hill, Victoria, Australia, 3128
Western Hospital
Footscray, Victoria, Australia, 3011
Frankston Hospital
Frankston, Victoria, Australia, 3199
The Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3050
Finland
Helsinki University Central Hospital
Helsinki, Finland
Sponsors and Collaborators
Neuroscience Trials Australia
Investigators
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Principal Investigator: Atte Meretoja, MD The Florey Institute of Neuroscience and Mental Health
Principal Investigator: Geoffrey A Donnan, MD The Florey Institute of Neuroscience and Mental Health
Principal Investigator: Stephen M Davis, MD Melbourne Health

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Neuroscience Trials Australia
ClinicalTrials.gov Identifier: NCT01702636     History of Changes
Other Study ID Numbers: NTA1201
First Posted: October 8, 2012    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019
Keywords provided by Neuroscience Trials Australia:
Stroke
Intracerebral Hemorrhage
ICH
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
Tomography, X-Ray Computed
Additional relevant MeSH terms:
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Cerebral Hemorrhage
Hemorrhage
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Intracranial Hemorrhages
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants