Defibrotide in Sickle Cell Disease-Related Acute Chest Syndrome

  • STATUS
    Recruiting
  • End date
    Jul 29, 2023
  • participants needed
    20
  • sponsor
    New York Medical College
Updated on 26 February 2022
chest x-ray
dyspnea
hemoglobin s
oximetry
cough
acute chest syndrome
chest syndrome
thalassemia
sickle cell trait
sickle hemoglobin
hemoglobin c disease

Summary

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

Details
Condition Sickle Cell Disease, Acute Chest Syndrome
Treatment Defibrotide
Clinical Study IdentifierNCT03805581
SponsorNew York Medical College
Last Modified on26 February 2022

Eligibility

Yes No Not Sure

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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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