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.
Undergoing heart or lung transplant, redo sternotomy, aortic surgery, and/or multi-valve repairs/replacements; and
At University Hospitals Cleveland Medical Center.
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.
Crossover
Hand Wrung
Procedure/SurgeryHand 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).
Level of Plasma Free Hemoglobin
Level of plasma free hemoglobin will be measured at baseline.
Level of Plasma Free Hemoglobin
Level of plasma free hemoglobin will be measured post-processing.
Change in Volume of Blood
Volume of blood will be measured at baseline and post-processing.
Number of Fragmented Red Blood Cells
Number of fragmented red blood cells will be measured at baseline.
Number of Fragmented Red Blood Cells
Number of fragmented red blood cells will be measured post-processing.
Level of Lactate Dehydrogenase
Level of lactate dehydrogenase will be measured at baseline.
Level of Lactate Dehydrogenase
Level of lactate dehydrogenase will be measured post-processing.
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University Hospitals Cleveland Medical Center
Lead sponsor
ProCell Surgical Inc.
Collaborator
