Please select the eligibility criteria that correspond to the clinical trial below.
Title: "Spot Sign" Selection of Intracerebral Hemorrhage to Guide Hemostatic Therapy: SPOTLIGHT
Brief Summary: This clinical trial will enroll 110 patients from approximately 15 Canadian stroke centres. Patients coming to the emergency department with bleeding in the brain not due to trauma or other known causes who can be treated within 6 hours of onset will undergo CT angiography using standard CT scanners ("CAT scan"). Those with a "spot sign", a type of marker on the CT scan that shows the brain is still bleeding, will be randomly assigned to a single injection of "factor 7"(a blood clotting drug used in hemophilia) or placebo (inactive saline); patients without a spot sign will not be treated. The researchers will look at how much bleeding happens after the treatments are administered, as well as clinical outcomes such as death and disability. The researchers think that factor 7 will cause the bleeding to stop faster and possibly decrease death and disability.


Options:
A: 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.
B: Inclusion Criteria

* Acute spontaneous primary supratentorial ICH diagnosed by CT scan.
* Presence of a spot sign within the hematoma on CTA source images
* Baseline ICH volume 3-90 ml
* Age 18 or older
* Investigator is able to randomize and administer study drug as soon as possible within a target of 60 minutes after CT angiogram and no later than 6 hours after stroke symptom onset (using the "last seen normal" principle).
* Plan to provide full medical care for at least 24 hours
* Assent-consent from patient or LAR prior to enrolment, or a waiver of consent (where REB approved) if patient/LAR assent-consent is not possible prior to enrolment.

Exclusion Criteria

* Brainstem or cerebellar hemorrhage.
* ICH secondary to known or suspected trauma, aneurysm, vascular malformation, hemorrhagic conversion of ischemic stroke, venous sinus thrombosis, thrombolytic treatment, tumour, or infection; or an in-hospital ICH or ICH as a result of any in-hospital procedure or illness.
* Baseline brain imaging shows evidence of acute or subacute ischemic stroke (chronic infarcts are not an exclusion).
* Contrast administration within the previous 24 hours.
* Evidence of thromboembolic risk factors, defined as any of the following: known history within the past 6 months of any of the following: (a) myocardial infarction, (b) coronary artery bypass surgery, (c) angina, (d) ischemic stroke, (e) transient ischemic attack, (f) carotid endarterectomy, (g) cerebral bypass surgery, (h) deep venous thrombosis, (i) pulmonary embolism, (j) any vascular angioplasty, stenting (coronary, peripheral vascular or cerebrovascular) or filter (e.g. vena cava filter);(k) prosthetic cardiac valve; and/or (l) known history of a high-risk thrombophilia (e.g. antithrombin III deficiency, antiphospholipid antibody syndrome, protein C deficiency, etc.)
* Known hereditary (e.g. hemophilia) or acquired hemorrhagic diathesis or coagulation factor deficiency.
* Any condition known that the investigator feels would pose a significant hazard if rFVIIa were administered.
* Planned surgery for ICH within 24 hours (placement of intraventricular catheter is not an exclusion).
* Planned withdrawal of care before 24 hours post-ICH onset.
* Known participation in another therapeutic trial.
* Known allergy or other contraindication to iodinated contrast dye.
* Known or suspected hypersensitivity to the trial product.
* Known unfractionated heparin use - must check PTT and exclude if elevated above upper limit of local lab's reference range.
* Known low-molecular weight heparin, heparinoid, factor X inhibitor, or direct thrombin inhibitor use within previous 7 days.
* Known GPIIb/IIIa antagonist use in previous 2 weeks.
* Known warfarin (or other anticoagulant) therapy with INR \>1.40. Note: if the patient is suspected to have cirrhosis, study staff are to wait for the INR value prior to dosing, and ensure not to enroll the patient if the INR value is \>1.40. Otherwise the physician should use their discretion if they believe the patient is not at risk for elevated INR.
* Concurrent or planned treatment with prothrombin complex concentrate, vitamin K, fresh frozen plasma, or platelet transfusion.
* Pregnancy or lactation. Women of childbearing potential must have a negative pregnancy test prior to randomization.
* Current clinical symptoms suggestive of acute coronary ischemia (e.g. chest pain).
* Baseline ECG evidence of acute coronary ischemia (e.g. ST elevation in 2 contiguous leads, new LBBB, ST depression).
* Baseline platelet count \<50,000 or INR \>1.40 or elevated PTT
C: 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.
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: B