University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Location status: Recruiting
Recruiting
NCT Number: NCT05545930
Analysis of Red Blood Cell Integrity and Efficiency of Recovery Using a Novel Surgical Sponge-Blood Recovery Device (ProCell)
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–89 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Hand Wrung
ProcedureHand wrung refers to manually wringing surgical sponges by hand.
ProCell Wrung
DeviceProCell wrung refers to automated wringing surgical sponges by an FDA approved suction device (ProCell).
Primary outcomes
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Level of Plasma Free Hemoglobin
Time frame: Baseline
Level of plasma free hemoglobin will be measured at baseline.
-
Level of Plasma Free Hemoglobin
Time frame: Post-Processing (Up to 120 Minutes)
Level of plasma free hemoglobin will be measured post-processing.
-
Change in Volume of Blood
Time frame: Baseline, Post-Processing (Up to 120 Minutes)
Volume of blood will be measured at baseline and post-processing.
Secondary outcomes
-
Number of Fragmented Red Blood Cells
Time frame: Baseline
Number of fragmented red blood cells will be measured at baseline.
-
Number of Fragmented Red Blood Cells
Time frame: Post-Processing (Up to 120 Minutes)
Number of fragmented red blood cells will be measured post-processing.
-
Level of Lactate Dehydrogenase
Time frame: Baseline
Level of lactate dehydrogenase will be measured at baseline.
-
Level of Lactate Dehydrogenase
Time frame: Post-Processing (Up to 120 Minutes)
Level of lactate dehydrogenase will be measured post-processing.
-
Level of Haptoglobin
Time frame: Baseline
Level of haptoglobin will be measured at baseline.
-
Level of Haptoglobin
Time frame: Post-Processing (Up to 120 Minutes)
Level of haptoglobin will be measured post-processing.
-
Change in Weight of Surgical Sponge
Time frame: Baseline, Post-Procedure (Up to 5 Minutes)
Weight of surgical sponges will be measured at baseline and post-procedure.
-
Time to Wring Sponges
Time frame: Up to 120 Minutes
Time to wring sponges will be measured.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
University Hospitals Cleveland Medical Center
Other
Collaborators
- ProCell Surgical Inc.
Registry information
Important dates
- Study start
- 2022
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Sep 19, 2022
- Registry last updated
- Jan 7, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.