Not provided
Not provided
Not provided
Not provided
Not provided
Due staffing issues
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| ProCell Surgical Inc. | UNKNOWN |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
|---|---|---|
| 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) |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Marc Pelletier, MD | University Hospitals Cleveland Medical Center | Principal Investigator |
| Craig Jarrett, MD, MBA | University Hospitals Cleveland Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Subjects will be blinded to the intervention.
| ProCell Wrung |
| Device |
ProCell wrung refers to automated wringing surgical sponges by an FDA approved suction device (ProCell). |
|
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 |