HEMolysis in a Percutaneous Axial Flow LVAD, Effects of Pentoxifylline in a Randomized Controlled Trial
Status:
Not yet recruiting
Trial end date:
2027-06-01
Target enrollment:
Participant gender:
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 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.