This study evaluates the safety of defibrotide in subjects with sickle cell disease (SCD)-associated acute chest syndrome (ACS).
| Mitchell S Cairo, MD | |
| 9145972150 | |
| [email protected] |
| Erin Morris, RN | |
| 7149645359 | |
| [email protected] |
1 United States site
2 Years - 40 Years
Hemoglobin SC
Phase 2
Interventional
All
Drug
SCD-associated ACS with the presence of any two or more of the following signs not explained by other etiologies: Fever, Chest pain, Cough, Dyspnea, Tachypnea for age, Pulmonary infiltrate on CXR and/or Chest CT scan, Decreased O2 saturation with or without oxygen supplement;
Age 2 to 40 years of age;
Homozygous Hemoglobin S Disease, Hemoglobin SC Disease or Hemoglobin S 0/+ thalassemia;
Informed consent/assent;
Consent of patient/parent within ≤72 hours after inpatient admission for SCD-associated ACS.
Females of childbearing age will have a negative pregnancy test.
Current Grade III or IV hemorrhage;
Previous hypersensitivity reaction to defibrotide;
Current systemic anti-coagulant therapy and/or fibrinolytic therapy;
Consent of patient/parent greater than 72 hours of inpatient admission for SCD-associated ACS;
No signed informed consent