Actively Recruiting
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
N/A
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
Researchers are comparing two methods of recovering blood from surgical sponges used during heart and lung surgeries. The study evaluates manual wringing by hand versus automated wringing using an FDA-approved suction device called ProCell. Both methods are currently used at University Hospitals based on the surgeon's choice. Participants undergo surgeries such as heart or lung transplants, redo sternotomies, aortic surgeries, or multi-valve repairs/replacements. During surgery, blood is recovered from sponges either by hand wringing or using the ProCell device. The study measures blood components and recovery efficiency at baseline and after processing up to 120 minutes. Participants are monitored during surgery and blood samples are analyzed for plasma free hemoglobin, fragmented red blood cells, lactate dehydrogenase, and haptoglobin levels. The volume and weight of blood recovered and the time taken to wring sponges are recorded. The study is conducted at University Hospitals and lasts through the surgical procedure and immediate post-processing period.
CONDITIONS
Brief Title
Analysis of Red Blood Cell Integrity and Efficiency of Recovery Using a Novel Surgical Sponge-Blood Recovery Device (ProCell)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Undergoing heart or lung transplant, redo sternotomy, aortic surgery, and/or multi-valve repairs/replacements
- Receiving care at University Hospitals Cleveland Medical Center
- Age between 18 and 89 years
You will not qualify if you...
- Known bleeding disorders, including disseminated intravascular coagulation, prothrombin deficiency, factor V, VII, X, 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
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 120 minutes
Participants undergo sponge wringing procedures using both manual hand wringing and the ProCell automated device to compare blood recovery efficiency.
1 procedural visit (in-person)
Trial Site Locations
Total: 1 location
1
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
Research Team
J
Jessica Hungate, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
CROSSOVER
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
Frequently Asked Questions
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