Status:
WITHDRAWN
HEMolysis in a Percutaneous Axial Flow LVAD, Effects of Pentoxifylline in a Randomized Controlled Trial
Lead Sponsor:
Cedars-Sinai Medical Center
Conditions:
Hemolysis Intravascular
Acute Decompensated Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Temporary mechanical circulatory support devices are increasingly used for short-term support in patients with decompensated cardiogenic shock. Recently, a new axial flow pump has become widely availa...
Detailed Description
Subjects will be screened prior to Impella device implant for eligibility. Informed consent will be obtained from eligible subjects. After implant of their Impella Device (5.0/5.5), results of laborat...
Eligibility Criteria
Inclusion
- Age \>/= 18 years of age
- Heart failure patients who undergo axillary Impella 5.0 or 5.5 insertion for acute decompensated heart failure
Exclusion
- Concomitant temporary mechanical circulatory support (ECMO, RVAD)
- Heparin induced thrombocytopenia
- Recent cerebral and/or retinal hemorrhage or in patients who have
- Previous intolerance to Pentoxifylline or methylxanthines such as caffeine, theophylline, and theobromine
- Women who are currently pregnant, nursing or planning on becoming pregnant.
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04391231
Start Date
June 1 2020
End Date
June 1 2022
Last Update
May 31 2025
Active Locations (1)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048