Defibrotide in Sickle Cell Disease-Related Acute Chest Syndrome

Therapuetic Areas:Hematology
Age Range:2 - 40
Start Date:January 12, 2018
End Date:January 2022
Contact:Mitchell S Cairo, MD

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A Phase II Study to Determine the Safety of Defibrotide in Sickle Cell Disease-Related Acute Chest Syndrome

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/+

- 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
We found this trial at
40 Sunshine Cottage Road
Valhalla, New York 10595
(914) 594-4000
Principal Investigator: Mitchell S. Cairo, MD
Phone: 914-594-2150
New York Medical College The College was founded in 1860 by a group of New...
Valhalla, NY
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