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

This study is currently recruiting participants.
Verified March 2013 by National Stroke Research Institute, Australia
Sponsor:
Information provided by (Responsible Party):
National Stroke Research Institute, Australia
ClinicalTrials.gov Identifier:
NCT01702636
First received: October 3, 2012
Last updated: March 19, 2013
Last verified: March 2013

October 3, 2012
March 19, 2013
December 2012
September 2014   (final data collection date for 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01702636 on ClinicalTrials.gov Archive Site
  • Major thromboembolic events (myocardial infarction, ischaemic stroke, pulmonary embolism) [ Time Frame: Within 90+/-7 days ] [ Designated as safety issue: Yes ]
  • Absolute ICH growth volume by 24±3 hours, adjusted for baseline ICH volume [ Time Frame: 24+/-3 hours ] [ Designated as safety issue: No ]
  • Absolute intraventricular haematoma (IVH) growth volume by 24±3 hours, adjusted for baseline IVH volume [ Time Frame: 24+/-3 hours ] [ Designated as safety issue: No ]
  • modified Rankin Scale (mRS) score of 0-4 at 3 months [ Time Frame: 90+/-7 days ] [ Designated as safety issue: No ]
  • modified Rankin Scale (mRS) score of 0-3 at 3 months [ Time Frame: 90+/-7 days ] [ Designated as safety issue: No ]
  • Categorical shift in mRS at 3 months, subject to the validity of proportional odds assumption [ Time Frame: 90+/-7 days ] [ Designated as safety issue: No ]
  • Death due to any cause by 3 months [ Time Frame: within 90+/-7 days ] [ Designated as safety issue: No ]
Same as current
  • ICH growth [ Time Frame: 24+/-3 hours ] [ Designated as safety issue: No ]
    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.
  • modified Rankin Scale (mRS) [ Time Frame: 90+/-7 days ] [ Designated as safety issue: No ]
    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.
Same as current
 
STOP-AUST: The Spot Sign and Tranexamic Acid On Preventing ICH Growth - AUStralasia Trial
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Intracerebral Haemorrhage
  • Stroke
  • Drug: Tranexamic Acid
  • Drug: Placebo
  • 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.
    Intervention: 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.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
December 2014
September 2014   (final data collection date for primary outcome measure)

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.
  • Pre-stroke modified Rankin Scale (mRS) score of >2
  • 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.
Both
18 Years and older
No
Contact: Atte Meretoja, MD +61 3 9342 8443 atte.meretoja@unimelb.edu.au
Australia
 
NCT01702636
NTA1201
Yes
National Stroke Research Institute, Australia
National Stroke Research Institute, Australia
Not Provided
Principal Investigator: Stephen M Davis, MD Melbourne Health
Principal Investigator: Geoffrey A Donnan, MD The Florey Institute of Neuroscience and Mental Health
National Stroke Research Institute, Australia
March 2013

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