Analysis of Red Blood Cell Integrity and Efficiency of Recovery Using a Novel Surgical Sponge-Blood Recovery Device (ProCell): Immediate Impact
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Hand Wrung Hand wrung refers to manually wringing surgical sponges by hand. |
Procedure: 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). |
Device: ProCell Wrung
ProCell wrung refers to automated wringing surgical sponges by an FDA approved suction device (ProCell).
|
Outcome Measures
Primary Outcome Measures
- Level of Plasma Free Hemoglobin [Baseline]
Level of plasma free hemoglobin will be measured at baseline.
- Level of Plasma Free Hemoglobin [Post-Processing (Up to 120 Minutes)]
Level of plasma free hemoglobin will be measured post-processing.
- Change in Volume of Blood [Baseline, Post-Processing (Up to 120 Minutes)]
Volume of blood will be measured at baseline and post-processing.
Secondary Outcome Measures
- Number of Fragmented Red Blood Cells [Baseline]
Number of fragmented red blood cells will be measured at baseline.
- Number of Fragmented Red Blood Cells [Post-Processing (Up to 120 Minutes)]
Number of fragmented red blood cells will be measured post-processing.
- Level of Lactate Dehydrogenase [Baseline]
Level of lactate dehydrogenase will be measured at baseline.
- Level of Lactate Dehydrogenase [Post-Processing (Up to 120 Minutes)]
Level of lactate dehydrogenase will be measured post-processing.
- Level of Haptoglobin [Baseline]
Level of haptoglobin will be measured at baseline.
- Level of Haptoglobin [Post-Processing (Up to 120 Minutes)]
Level of haptoglobin will be measured post-processing.
- Change in Weight of Surgical Sponge [Baseline, Post-Procedure (Up to 5 Minutes)]
Weight of surgical sponges will be measured at baseline and post-procedure.
- Time to Wring Sponges [Up to 120 Minutes]
Time to wring sponges will be measured.
Eligibility Criteria
Criteria
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:
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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);
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Patients undergoing emergent or emergent salvage surgery; and
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Patients actively participating in another clinical trial which could affect outcomes.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospitals Cleveland Medical Center | Cleveland | Ohio | United States | 44106 |
Sponsors and Collaborators
- Marc Pelletier
- ProCell Surgical Inc.
Investigators
- Principal Investigator: Marc Pelletier, MD, University Hospitals Cleveland Medical Center
- Principal Investigator: Craig Jarrett, MD, MBA, University Hospitals Cleveland Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STUDY20220888_1