RecruitingNot Applicable

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

United States20 participantsStarted 2022-09-20

Plain-language summary

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.

Who can participate

Age range18 Years – 89 Years

SexALL

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Inclusion Criteria: * Undergoing heart or lung transplant, redo sternotomy, aortic surgery, and/or multi-valve repairs/replacements; and * At University Hospitals Cleveland Medical Center. Exclusion Criteria: * Patients with known bleeding disorders, including disseminated intravascular coagulation (DIC), prothrombin deficiency, factor V deficiency, factor VII deficiency, factor X deficiency, factor XI deficiency (hemophilia C), Glanzmann disease, hemophilia A, hemophilia B, idiopathic thrombocytopenic purpura (ITP), and Von Willebrand disease (types I, II, and III); * Patients undergoing emergent or emergent salvage surgery; and * Patients actively participating in another clinical trial which could affect outcomes.

What they're measuring

Level of Plasma Free Hemoglobin

Timeframe: Baseline

Level of Plasma Free Hemoglobin

Timeframe: Post-Processing (Up to 120 Minutes)

Change in Volume of Blood

Timeframe: Baseline, Post-Processing (Up to 120 Minutes)

Trial details

NCT IDNCT05545930

SponsorUniversity Hospitals Cleveland Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07-01

Contact for this trial

Jessica Hungate, MD

216-844-3800 Jessica.Hungate@UHhospitals.org