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RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: University Hospitals Cleveland Medical Center • ClinicalTrials.gov ID: NCT05545930

Registry updated: 2026-09-25
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Description

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.

Interventions

  • Hand Wrung (Procedure)
    Hand wrung refers to manually wringing surgical sponges by hand.
  • ProCell Wrung (Device)
    ProCell wrung refers to automated wringing surgical sponges by an FDA approved suction device (ProCell).

Eligibility criteria

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.

Conditions

Blood Recovery

Locations

  • University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record