Status:
COMPLETED
Defibrotide in Sickle Cell Disease-Related Acute Chest Syndrome
Lead Sponsor:
New York Medical College
Collaborating Sponsors:
Johns Hopkins University
Conditions:
Sickle Cell Disease
Acute Chest Syndrome
Eligibility:
All Genders
2-40 years
Phase:
PHASE2
Brief Summary
This study evaluates the safety of defibrotide in subjects with sickle cell disease (SCD)-associated acute chest syndrome (ACS).
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 7 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03805581
Start Date
January 12 2018
End Date
November 7 2023
Last Update
December 8 2023
Active Locations (1)
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1
New York Medical College
Valhalla, New York, United States, 10595