A Phase 4 interventional study of Pentoxifylline Oral Product and Placebo in Hemolysis Intravascular and Acute Decompensated Heart Failure, sponsored by Cedars-Sinai Medical Center. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-31.
Sponsored by Cedars-Sinai Medical Center · Phase 4, Interventional, and Treatment
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 available with the Impella System. The Impella has been FDA approved for short term usage. Hemolysis, however, has been a common complication that has increased morbidity and mortality in this patient population.
It is hypothesized that a major source of hemolysis in this patient population is shear stress experienced by red blood cells (RBC) as they travel through the pump device. In addition to causing RBC loss and potential anemia, the hemolysis has multiple other downstream consequences including creation of a pro-thrombotic environment leading to clot formation and potential device failure and secondary end organ dysfunction (renal and liver failure). Due to the significant effects of hemolysis in this population, a great deal of interest has been recently focused on addressing this problem, but as of yet no durable solutions exist.
Pentoxifylline improves red blood cell deformability and reduces blood viscosity. It is hypothesized here that administering Pentoxifylline to patients in CS who require temporary MCS will decrease the amount of shear stress related hemolysis through the improved deformability and durability of RBCs. We propose to perform a double-blinded randomized controlled trial in patients who undergo an axillary Impella 5.0 insertion for acute decompensated heart failure. There will be a control group who receives a placebo and the treatment group who receives pentoxifylline. Labs will be drawn to monitor hemolysis which is our current standard protocol for the life of the device to determine the efficacy of pentoxifylline in decreasing hemolysis in this patient population.
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 laboratory tests (plasma free hemoglobin \& lactate dehydrogenase levels) every 12 hrs for the first 3 days and then daily thereafter. Subjects will receive study medication every 6 hrs from device implant until device explant, death or Day 30 occurs. Impella therapy, concomitant medications and adverse events will be collected until the same. Subjects that don't qualify or opt out of participating will not receive the study medication. The data being collected for the study is based on routine standard of care. The difference between the SOC Impellas subjects and the study patients is the addition of Pentoxifylline being administered along with their SOC medications.
120 studies on the registry are indexed under Hemolysis; 22 are open to participants now.
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Exclusion Criteria:
Pentoxifylline (in suspension with SyrSpend SF)
Drug: Pentoxifylline Oral Product
Placebo (SyrSpend SF only)
Drug: Placebo
Blinded Pentoxifylline (in suspension with SyrSpend SF)
Placebo (SyrSpend SF only)
Reduction in REBC hemolysis
Measured by change in plasma free hemoglobin and lactate dehydrogenase levels
Time frame: Up to 30 Days post-device implant
hemolysis requiring adjustment of device speed settings
Measured by change in plasma free hemoglobin and lactate dehydrogenase levels
Time frame: Up to 30 Days post-device implant
device malfunction
Impella system malfunction requiring intervention or device replacement
Time frame: Up to 30 Days post-device implant
duration of Impella support
Hours/days of Impella use
Time frame: Up to 30 Days post-device implant
bleeding
As assessed by drop in blood count
Time frame: Up to 30 Days post-device implant
infection
Assessed by fever and changes in laboratory assessments
Time frame: Up to 30 Days post-device implant
death
morbidity from all causes
Time frame: Up to 30 Days post-device implant
Plan to share: No
This study is withdrawn, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Pentoxifylline