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| Name | Class |
|---|---|
| ProCell Surgical Inc. | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hand Wrung | Active Comparator | Hand wrung refers to manually wringing surgical sponges by hand. |
|
| ProCell Wrung | Experimental | ProCell wrung refers to automated wringing surgical sponges by an FDA approved suction device (ProCell). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hand Wrung | Procedure | Hand wrung refers to manually wringing surgical sponges by hand. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Level of Plasma Free Hemoglobin | Level of plasma free hemoglobin will be measured at baseline. | Baseline |
| Level of Plasma Free Hemoglobin | Level of plasma free hemoglobin will be measured post-processing. | Post-Processing (Up to 120 Minutes) |
| Change in Volume of Blood | Volume of blood will be measured at baseline and post-processing. | Baseline, Post-Processing (Up to 120 Minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Fragmented Red Blood Cells | Number of fragmented red blood cells will be measured at baseline. | Baseline |
| Number of Fragmented Red Blood Cells | Number of fragmented red blood cells will be measured post-processing. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jessica Hungate, MD | Contact | 216-844-3800 | Jessica.Hungate@UHhospitals.org |
| Name | Affiliation | Role |
|---|---|---|
| Rakesh Arora, MD | University Hospitals Cleveland Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Cleveland Medical Center | Recruiting | Cleveland | Ohio | 44106 | United States |
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Subjects will be blinded to the order of intervention.
| ProCell Wrung |
| Device |
ProCell wrung refers to automated wringing surgical sponges by an FDA approved suction device (ProCell). |
|
| Post-Processing (Up to 120 Minutes) |
| Level of Lactate Dehydrogenase | Level of lactate dehydrogenase will be measured at baseline. | Baseline |
| Level of Lactate Dehydrogenase | Level of lactate dehydrogenase will be measured post-processing. | Post-Processing (Up to 120 Minutes) |
| Level of Haptoglobin | Level of haptoglobin will be measured at baseline. | Baseline |
| Level of Haptoglobin | Level of haptoglobin will be measured post-processing. | Post-Processing (Up to 120 Minutes) |
| 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 to wring sponges will be measured. | Up to 120 Minutes |