Recruiting

ProCell

Sponsor:

University Hospitals Cleveland Medical Center

Code:

NCT05545930

Conditions

Blood Recovery

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Hand Wrung

ProCell Wrung

Study Details

Brief 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.

Conditions

Blood Recovery

Study ID

NCT05545930

Start date

Sep 20, 2022

Status verified date

Jan, 2026

Completion date

Jul 1, 2026

Anticipated

Primary completion date

Jul 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Crossover

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Hand Wrung

Hand wrung refers to manually wringing surgical sponges by hand.

experimental: ProCell Wrung

ProCell wrung refers to automated wringing surgical sponges by an FDA approved suction device (ProCell).

Interventions

Hand Wrung

Hand wrung refers to manually wringing surgical sponges by hand.

ProCell Wrung

ProCell wrung refers to automated wringing surgical sponges by an FDA approved suction device (ProCell).

Primary outcome measure

  • Level of Plasma Free Hemoglobin [ Time Frame: Baseline ]
  • Level of Plasma Free Hemoglobin [ Time Frame: Post-Processing (Up to 120 Minutes) ]
  • Change in Volume of Blood [ Time Frame: Baseline, Post-Processing (Up to 120 Minutes) ]

Central Contacts and Locations

Central contacts

Jessica Hungate, MD

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

Locations

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Craig Jarrett, MD, MBA

216-286-7297Craig.Jarrett@UHhospitals.org

More Information

Sponsor

University Hospitals Cleveland Medical Center

Last update posted

Jan 7, 2026

Last verified

Jan, 2026

Keywords

  • Open Heart Surgery
  • Heart Transplant
  • Lung Transplant
  • ProCell

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Hospitals Cleveland Medical Center on 2026-01-07.