NCT05545930NARecruiting
Analysis of Red Blood Cell Integrity and Efficiency of Recovery Using a Novel Surgical Sponge-Blood Recovery Device (ProCell)
University Hospitals Cleveland Medical Center
Start Date
9/20/2022
Completion Date
7/1/2026
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.
Eligibility Criteria
Age Range: 18 years to 89 years
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.
Interventions
PROCEDURE
Hand Wrung
DEVICE
ProCell Wrung
Conditions
Blood Recovery
Locations
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United States