Analysis of Red Blood Cell Integrity and Efficiency of Recovery Using a Novel Surgical Sponge-Blood Recovery Device (ProCell): Delayed Impact

Study Overview
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Brief Summary
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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.

Official Title
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Analysis of Red Blood Cell Integrity and Efficiency of Recovery Using a Novel Surgical Sponge-Blood Recovery Device (ProCell): Delayed Impact

Conditions
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Blood Recovery

Intervention / Treatment
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* Procedure: Hand Wrung
* Device: ProCell Wrung


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hand Wrung<br>Hand wrung refers to manually wringing surgical sponges by hand. | Procedure: Hand Wrung<br>* Hand wrung refers to manually wringing surgical sponges by hand.<br>|
| Experimental: ProCell Wrung<br>ProCell wrung refers to automated wringing surgical sponges by an FDA approved suction device (ProCell). | Device: ProCell Wrung<br>* ProCell wrung refers to automated wringing surgical sponges by an FDA approved suction device (ProCell).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Units of Packed Red Blood Cells Transfused | Units of packed red blood cells transfused will be measured. | Up to 72 Hours Post-Operative | 
| Change in Level of Hematocrit | Level of hematocrit will be measured at baseline and post-operative. | Baseline, Post-Operative Hours 0, 6, 12, 18, 24, 48, and 72 | 
| Change in Level of Plasma Free Hemoglobin | Level of plasma free hemoglobin will be measured at baseline and post-operative. | Baseline, Post-Operative Hours 0, 6, 12, 18, 24, 48, and 72 | 
| Change in Volume of Blood | Volume of blood will be measured at baseline and post-processing. | Baseline, Post-Processing (Up to 120 Minutes) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Number of Fragmented Red Blood Cells | Number of fragmented red blood cells will be measured at baseline and post-operative. | Baseline, Post-Operative Hours 0, 6, 12, 18, 24, 48, and 72 | 
| Change in Level of Lactate Dehydrogenase | Level of lactate dehydrogenase will be measured at baseline and post-operative. | Baseline, Post-Operative Hours 0, 6, 12, 18, 24, 48, and 72 | 
| Change in Level of Haptoglobin | Level of haptoglobin will be measured at baseline and post-operative. | Baseline, Post-Operative Hours 0, 6, 12, 18, 24, 48, and 72 | 
| Change in Level of Bilirubin | Level of bilirubin will be measured at baseline and post-operative. | Baseline, Post-Operative Hours 0, 6, 12, 18, 24, 48, and 72 | 
| Change in Weight of Surgical Sponge | Weight of surgical sponges will be measured at baseline and post-procedure. | Baseline, Post-Procedure (Up to 5 Minutes) | 
| Time to Wring Sponges | Time in seconds to wring sponges will be measured. | Up to 120 Minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Open Heart Surgery, Heart Transplant, Lung Transplant, ProCell