Actively Recruiting

Phase Not Applicable
Age: 18Years - 89Years
All Genders
NCT05545930

Analysis of Red Blood Cell Integrity and Efficiency of Recovery Using a Novel Surgical Sponge-Blood Recovery Device (ProCell)

Led by University Hospitals Cleveland Medical Center · Updated on 2026-01-07

20

Participants Needed

1

Research Sites

197 weeks

Total Duration

On this page

Sponsors

U

University Hospitals Cleveland Medical Center

Lead Sponsor

P

ProCell Surgical Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

The purpose of this research study is to compare two methods of recovering blood from surgical sponges used during heart and lung surgeries. The two methods are: 1) manually wringing sponges by hand, and 2) automated wringing sponges by an FDA approved suction device. Both methods are already in use in heart and lung surgeries at University Hospitals at the discretion of the surgeon.

CONDITIONS

Official Title

Analysis of Red Blood Cell Integrity and Efficiency of Recovery Using a Novel Surgical Sponge-Blood Recovery Device (ProCell)

Who Can Participate

Age: 18Years - 89Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Undergoing heart or lung transplant, redo sternotomy, aortic surgery, and/or multi-valve repairs/replacements
  • Surgery performed at University Hospitals Cleveland Medical Center
Not Eligible

You will not qualify if you...

  • Known bleeding disorders including disseminated intravascular coagulation, prothrombin deficiency, factor V, VII, X, or XI deficiencies, Glanzmann disease, hemophilia A or B, idiopathic thrombocytopenic purpura, and Von Willebrand disease types I, II, and III
  • Undergoing emergent or emergent salvage surgery
  • Actively participating in another clinical trial that could affect outcomes

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States, 44106

Actively Recruiting

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Research Team

J

Jessica Hungate, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

NON_RANDOMIZED

Model

CROSSOVER

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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