Status:
UNKNOWN
5-day Defibrotide Treatment for Hepatic SOS/VOD
Lead Sponsor:
Loyola University
Conditions:
Sinusoidal Obstruction Syndrome
Veno-occlusive Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Sinusoidal Obstruction Syndrome (SOS), also referred to as hepatic veno-occlusive disease (VOD), is rare but serious complication of allogeneic stem cell transplantation (allo-SCT). Defibrotide is the...
Detailed Description
Sinusoidal obstructive syndrome (SOS) has a reported mean incidence of 13.7% and even among those undergoing reduced intensity conditioning regimens is approximately 9%. SOS is a clinical syndrome cha...
Eligibility Criteria
Inclusion
- Patients who underwent allogeneic stem cell transplantation
- Age \>/= 18 years
- Diagnosed hepatic SOS/VOD either by Baltimore Criteria or Modified Seattle Criteria including up to 60 days post-transplantation.
Exclusion
- Significant uncontrolled bleeding
- Prior or concurrent systemic t-PA
- Concomitant use of therapeutic heparin or other anticoagulants (except use of heparin for central access patency)
- Hemodynamic instability (\>1 pressor gent to maintain blood pressure)
Key Trial Info
Start Date :
March 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2022
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04313036
Start Date
March 11 2021
End Date
August 1 2022
Last Update
April 23 2021
Active Locations (1)
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1
Loyola University Medical Center
Maywood, Illinois, United States, 60153