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HEMolysis in a Percutaneous Axial Flow LVAD, Effects of Pentoxifylline in a Randomized Controlled Trial

Sponsor
Cedars-Sinai Medical Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04391231
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
68.5
Anticipated Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Pentoxifylline Oral Product
  • Drug: Placebo
 Phase 4

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 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This study will be a double-blinded randomized placebo-controlled study to determine the efficacy of Pentoxifylline in reducing RBC hemolysis caused by Impella support.This study will be a double-blinded randomized placebo-controlled study to determine the efficacy of Pentoxifylline in reducing RBC hemolysis caused by Impella support.
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
This study will be a double-blinded randomized placebo-controlled study.
Primary Purpose:
Treatment
Official Title:
HEMolysis in a Percutaneous Axial Flow Left Ventricular Assist Device, Effects of Pentoxifylline in a Randomized Controlled Trial
Anticipated Study Start Date :
Sep 15, 2021
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Jun 1, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pentoxifylline Arm

Pentoxifylline (in suspension with SyrSpend SF)

Drug: Pentoxifylline Oral Product
Blinded Pentoxifylline (in suspension with SyrSpend SF)
Placebo Comparator: Placebo Arm

Placebo (SyrSpend SF only)

Drug: Placebo
Placebo (SyrSpend SF only)

Outcome Measures

Primary Outcome Measures

  1. Reduction in REBC hemolysis [Up to 30 Days post-device implant]

    Measured by change in plasma free hemoglobin and lactate dehydrogenase levels

Secondary Outcome Measures

  1. hemolysis requiring adjustment of device speed settings [Up to 30 Days post-device implant]

    Measured by change in plasma free hemoglobin and lactate dehydrogenase levels

  2. device malfunction [Up to 30 Days post-device implant]

    Impella system malfunction requiring intervention or device replacement

  3. duration of Impella support [Up to 30 Days post-device implant]

    Hours/days of Impella use

  4. bleeding [Up to 30 Days post-device implant]

    As assessed by drop in blood count

  5. infection [Up to 30 Days post-device implant]

    Assessed by fever and changes in laboratory assessments

  6. death [Up to 30 Days post-device implant]

    morbidity from all causes

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Age >/= 18 years of age

  • Heart failure patients who undergo axillary Impella 5.0 or 5.5 insertion for acute decompensated heart failure

Exclusion Criteria:

  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cedars-Sinai Medical Center Los Angeles California United States 90048

Sponsors and Collaborators

  • Cedars-Sinai Medical Center

Investigators

  • Principal Investigator: Domininc Emerson, MD, Cedars-Sinai Medical Center; Smidt Heart Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Dominic Emerson, MD, Staff Physician, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT04391231
Other Study ID Numbers:
  • CSMC - STUDY00000179
First Posted:
May 18, 2020
Last Update Posted:
Aug 19, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Dominic Emerson, MD, Staff Physician, Cedars-Sinai Medical Center
CHF
Hemolysis
Impella
Additional relevant MeSH terms:
Hemolysis
Pentoxifylline

Study Results

No Results Posted as of Aug 19, 2021