Valhalla, New York 10595


Purpose:

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


Criteria:

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


NCT ID:

NCT03805581


Primary Contact:

Principal Investigator
Mitchell S Cairo, MD
New York Medical College

Mitchell S Cairo, MD
Phone: 9145972150
Email: mitchell_cairo@nymc.edu


Backup Contact:

Email: erin_morris@nymc.edu
Erin Morris, RN
Phone: 7149645359


Location Contact:

Valhalla, New York 10595
United States

Mitchell S Cairo, MD
Phone: 914-594-2150
Email: mitchell_cairo@nymc.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

If you would like to be contacted by the clinical trial representative please fill out the form below.