Please select the eligibility criteria that correspond to the clinical trial below.
Title: Safety of Adenosine 2A Agonist Lexiscan in Children and Adults With Sickle Cell Disease
Brief Summary: Sickle cell disease (SCD) is an inherited blood disorder that causes the red blood cells to change their shape from a round shape to a half-moon/crescent or sickled shape. People who have SCD have a different type of protein that carries oxygen in their blood (hemoglobin) then people without SCD. This different type of hemoglobin makes the red blood cells change into a crescent shape under certain conditions. Sickle-shaped cells are a problem because they often get stuck in blood vessels blocking the flow of blood, and cause inflammation and injury to the important areas in the body. Lexiscan is drug that may prevent this inflammation and injury caused by the sickle shaped cells. This drug is approved by the FDA to be used as a fast infusion during a heart stress test in people who are unable to exercise enough to put stress on their heart by making it beat faster. Lexiscan has never been studied in patients with SCD and has never been given as a long infusion.


Options:
A: Postmenopausal women ages 50 to 79.
B: Inclusion Criteria Stage I/II/IIb: (COMPLETE AND CLOSED TO ACCRUAL)

* Participants must have sickle cell anemia confirmed by hemoglobin analysis
* Participants must report that their pain is at baseline. Additionally, they cannot report an increase in dose or frequency of opioid use in the last 2 weeks prior to drug administration
* Age 21-70 years
* Participants must have the laboratory indices as outlined in the protocol
* Participants must have reliable IV access as determined by the investigator
* Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of the study.

Inclusion Criteria Stage III: (COMPLETE AND CLOSED TO ACCRUAL)

* Participants must have sickle cell anemia confirmed by hemoglobin analysis
* Participant is admitted to the hospital for a pain episode
* Age 21-70 years
* Participants must have the laboratory indices as outlined in the protocol
* Participants must have reliable IV access as determined by the investigator
* Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation

Inclusion Criteria Stage IV: (open, still accruing volunteers)

* Participants must have sickle cell disease confirmed by hemoglobin analysis
* Participant is admitted to the hospital for a pain episode
* Ages of assent (10 to 17 years at DFCI, but different depending on institution)
* Participants must have the laboratory indices as outlined in the protocol
* Participants must have reliable IV access as determined by the investigator
* Participants and parents must have the ability to understand and the willingness to sign a written informed consent and assent document
* Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation

Exclusion Criteria Stage I/II/IIb: (COMPLETE AND CLOSED TO ACCRUAL)

* Participants with a current physician diagnosis of asthma (within last 12 months), require continuous supplemental oxygen, or predicted or current use of some asthma medications.
* Participants with second- or third-degree AV block or sinus node dysfunction
* Have a history of bleeding diathesis
* Have a history of clinically overt stroke
* Have a history of severe hypertension not adequately controlled with anti-hypertensive medications
* Participants who are receiving chronic anti-coagulation or anti-platelet therapy
* Participants with a history of metastatic cancer
* Participants who have had a hospitalization or emergency room visit for any reason in the past 2 weeks
* Participants may not be receiving any other study agents or have received a study agent in the past 30 days
* Uncontrolled intercurrent illness
* Pregnant or breastfeeding women
* Participants with HIV
* Participants who have previously enrolled and received the investigational agent as part of this study
* Participants who are taking medications that may interact with the investigational agent

Exclusion Criteria Stage III: (COMPLETE AND CLOSED TO ACCRUAL)

* Participants with a current physician diagnosis of asthma (within last 12 months), require continuous supplemental oxygen, or predicted or current use of some asthma medications.
* Participants with second- or third-degree AV block or sinus node dysfunction
* Have a history of bleeding diathesis
* Have a history of clinically overt stroke
* Have a history of severe hypertension not adequately controlled with anti-hypertensive medications
* Participants who are receiving chronic anti-coagulation or anti-platelet therapy
* Participants with a history of metastatic cancer
* Participants may not be receiving any other study agents or have received a study agent in the past 30 days

Exclusion Criteria Stage IV: (open, still accruing volunteers)

* Participants with a current physician diagnosis of asthma (within last 12 months), require continuous supplemental oxygen, or predicted or current use of some asthma medications.
* Participants with second- or third-degree AV block or sinus node dysfunction
* Have a history of bleeding diathesis
* Have a history of clinically overt stroke
* Have a history of hypertension not adequately controlled with anti-hypertensive medications
* Participants who are receiving chronic anti-coagulation or anti-platelet therapy
* Participants with a history of metastatic cancer
* Participants may not be receiving any other study agents or have received a study agent in the past 30 days
* Participants with HIV
* Participants who have previously enrolled and received the investigational agent as part of this study
* Participants who are taking medications that may interact with the investigational agent
C: Inclusion Criteria:

* age 4-21 years, inclusive
* Sickle cell anemia (Hb SS) or Sickle beta zero thalassemia disease (Hb Sβ°)
* failed intravenous opioid pain management in the emergency department prior to the decision to admit the patient
* admitted to the inpatient unit for sickle cell pain crisis

Exclusion Criteria:

* patient received more than 12 hours of intravenous pain medication prior to enrollment
* previous enrollment in this study (only one admission per child is eligible)
* history of allergy/intolerance to both intravenous morphine and hydromorphone
* known other cause for pain (avascular necrosis, gall bladder disease, priapism, etc.)
* patient with greater than 10 admissions for pain crisis in the past year
* patient maintained on daily opioids or chronic transfusions for chronic sickle cell pain
* transfusion within the previous two months
* known kidney or liver failure (elevation of liver function tests does not warrant exclusion)
* known pulmonary hypertension
* pregnancy
* diagnosis of bacterial infection, fever ≥39.5°C, acute chest syndrome, hemodynamic instability or sepsis
* current oral magnesium supplementation or current enrollment in another therapeutic study protocol
* previously diagnosed clinical stroke
* current or planned use of neuromuscular blocker, nifedipine, ritodrine, or terbutaline
* allergy to magnesium sulfate
* discharge from an inpatient unit within 72 hours of arrival in the emergency department for the current pain crisis
D: Inclusion Criteria:

* Known sickle cell disease
* Previous painful crisis resulting in an Emergency Department(ED) visit
* Current visit with a chief complaint of pain
* Age 4 years - 18 years
* Staff ED decides to admit to the hospital
* Staff ED decides to start an intravenous line

Exclusion Criteria:

* Fever (\>38.5C) during the 24 hours prior to visit at triage
* Patients transfused within 90 days of study entry
* Patients with known renal disease
* Patients with known heart block or myocardial damage
* Patients who take a magnesium-containing medication or calcium channel blocker on a regular basis
* Patients who received anesthetics, cardiac glycosides and neuromuscular blockers during the acute illness in the last 24 hours
* Patients or parents unable to communicate in English
* Known pregnancy
* Known allergy to Magnesium
* Admission to the ICU
* Enrolment to the study in the last 30 days

Answer: B