Please select the eligibility criteria that correspond to the clinical trial below.
Title: STOP-AUST: The Spot Sign and Tranexamic Acid On Preventing ICH Growth - AUStralasia Trial.
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.


Options:
A: 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.
B: Inclusion Criteria:

* Adults (≥18 years)
* Confirmed intracerebral haemorrhage on imaging
* Less than 24 hours from onset of symptoms \[or from when last seen free of stroke symptoms\]
* Prescribed and thought to be taking a daily oral antiplatelet drug in the preceding seven days (cyclooxygenase inhibitors, phosphodiesterase inhibitors or P2Y12 inhibitors)
* Signed consent (or waiver of consent).

Exclusion Criteria:

* Aneurysmal subarachnoid haemorrhage known at time of enrolment
* Haemorrhage suspected to be due to transformation of ischaemic stroke
* Haemorrhage known to be due to thrombolytic drug
* Haemorrhage known to be due to venous thrombosis
* Risk/s of fluid retention associated with desmopressin judged clinically significant by the attending physician (for example patients with pulmonary oedema and/or cardiac failure) - - Significant hypotension (systolic blood pressure \<90mmHg)
* Known drug-eluting coronary artery stent in previous three months
* Allergy to desmopressin
* Pregnant or breast-feeding
* Life expectancy less than four hours, or planned for palliative care only
* Glasgow coma scale less than 5, mRS \>4.
C: 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.
D: Inclusion Criteria:

* Acute, spontaneous ICH (including bleeding in cerebellum) diagnosed by non-enhanced CT scan within five hours of symptom onset. (Time of onset is defined as the last time the patient was witnessed to be at baseline (i.e., subjects who have stroke symptoms upon awakening will be considered to have their onset at beginning of sleep)
* Age \>/= 18 years through 80 years (candidates must have had their 18th birthday, but not had their 81st birthday)
* For spot positive patients, dosing of study drug within 90 minutes of enrolling CT scan

Exclusion Criteria:

* Time of symptom onset of ICH is unknown or more than five hours prior to baseline CT scan,
* ICH secondary to known or suspected trauma, aneurysm, vascular malformation, hemorrhagic conversion of ischemic stroke, venous sinus thrombosis, thrombolytic treatment of any condition (e.g., myocardial infarction, cerebral infarction, etc.), central nervous system (CNS) tumor or CNS infection
* Brainstem location of hemorrhage (patients with cerebellar hemorrhage may be enrolled)
* Serum creatinine \> 1.4 mg/dl (123 μmol/L). Sites that currently perform CTA as standard of care for ICH will follow their standard procedures regarding renal insufficiency.
* Known allergy to iodinated contrast media
* Intravenous or intra-arterial administration of iodinated contrast media within the previous 24 hours of baseline CT scan
* Known hereditary (e.g., hemophilia) or acquired hemorrhagic diathesis, coagulation factor deficiency, or anticoagulant therapy with international normalized ration (INR) \> 1.2
* Known or suspected thrombocytopenia (unless current platelet count documented above 50,000 / μl)
* Unfractionated heparin use with abnormal partial thromboplastin time (PTT)
* Low-molecular weight heparin use within the previous 24 hours
* GPIIb/IIIa antagonist use in the previous two weeks
* Direct thrombin inhibitor or factor Xa inhibitor within the previous 48 hours
* Glasgow Coma Scale score \< 8 at time of proposed enrollment
* Pre-admission modified Rankin Scale score \> 2
* Baseline ICH volume of \< 0.5 cc (Hematoma volume will be estimated by local investigators from the baseline CT using the "ABC / 2 method".)
* Baseline ICH volume of \> 90 cc
* Planned surgical evacuation of ICH within 24 hours of symptom onset (placement of intraventricular catheter is not a contraindication to study enrollment.)
* Evidence of acute or subacute ischemic stroke on baseline qualifying CT scan
* Clinical history of thromboembolism or ischemic vascular disease, including myocardial infarction, coronary artery bypass surgery, cardiac angina, transient ischemic attack, ischemic stroke, peripheral artery disease (vascular claudication), cerebral bypass surgery, carotid endarterectomy, deep venous thrombosis, pulmonary embolism, or coronary or cerebrovascular angioplasty or stenting. (Clinically silent evidence of old ischemia on EKG (Q waves) or CT scan (silent old infarct) will not be considered reasons for exclusion.)
* Baseline electrocardiogram shows evidence of acute cardiac ischemia (ST elevation in two contiguous leads, new left bundle branch block (LBBB), or ST depression)
* Clinical history suggestive of acute cardiac ischemia (e.g., chest pain)
* Abnormal baseline troponin
* Females of childbearing potential who are known to be pregnant and/or lactating or who have positive pregnancy tests on admission
* Advanced or terminal illness or any other condition the investigator feels would pose a significant hazard to the patient if rFVIIa were administered
* Recent (within 30 days) participation in any investigational drug or device trial or earlier participation in any investigational drug or device trial for which the duration of effect is expected to persist until the time of STOP-IT enrollment
* Planned withdrawal of care or comfort care measures
* Patient known or suspected of not being able to comply with trial protocol (e.g., due to alcoholism, drug dependency or psychological disorder)
* Informed consent cannot be obtained from the patient or legally authorized representative

Answer: C