Valhalla, New York 10595


This study evaluates the safety of defibrotide in subjects with sickle cell disease (SCD)-associated acute chest syndrome (ACS).


Inclusion Criteria: - 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. Exclusion Criteria: - 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



Primary Contact:

Principal Investigator
Mitchell S Cairo, MD
New York Medical College

Mitchell S Cairo, MD
Phone: 9145972150

Backup Contact:

Erin Morris, RN
Phone: 7149645359

Location Contact:

Valhalla, New York 10595
United States

Mitchell S Cairo, MD
Phone: 914-594-2150

Site Status: Recruiting

Data Source:

Date Processed: February 04, 2019

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