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Cardiopulmonary Bypass Induced Red Blood Cell Lysis
Studying the dynamics of red blood cell lysis, pfH, protective proteins and organ injury, limits will be set for safe levels of pfH following the use of CPB. These results will be compared to existing laboratory-based methods for determining red blood cell damage to predict CPB assist device safety. Further, results from the studies described in this proposal will help develop therapeutic strategies to benefit patients by early detection of pfH and clearance protein levels that occur during CPB.
Conditions:
🦠 Cardiopulmonary Bypass 🦠 Cardiac Surgery 🦠 Kidney Injury, Acute
🗓️ Study Start (Actual) 22 March 2022
🗓️ Primary Completion (Estimated) November 2024
✅ Study Completion (Estimated) 1 January 2026
👥 Enrollment (Estimated) 90
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Baltimore, Maryland, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Admitted to UMMC for cardiac procedure
    • * Age: \>/=18 y.o TO 75 y.o.
    • * Undergoing CPB \>1hr for the following surgeries (a) complex cardiac surgery (b) heart valve replacement surgery OR (c) CABG surgery.

    Exclusion Criteria:

    • * Pregnant
    • * Non English speaking
    • * Unable to consent or have Legally Authorized Representative (LAR) assent to study
Ages Eligible for Study: 18 Years to 75 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 9 November 2021
  • First Submitted that Met QC Criteria 11 January 2022
  • First Posted 12 January 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 1 November 2023
  • Last Update Posted 2 November 2023
  • Last Verified November 2023
I'm interested ...!!