Blood Recovery
Conditions
Keywords
Open Heart Surgery, Heart Transplant, Lung Transplant, ProCell
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.
Interventions
PROCEDUREHand Wrung
Hand wrung refers to manually wringing surgical sponges by hand.
DEVICEProCell Wrung
ProCell wrung refers to automated wringing surgical sponges by an FDA approved suction device (ProCell).
Sponsors
ProCell Surgical Inc.
University Hospitals Cleveland Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Masking description
Subjects will be blinded to the intervention.
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Units of Packed Red Blood Cells Transfused | Up to 72 Hours Post-Operative | Units of packed red blood cells transfused will be measured. |
| Change in Level of Hematocrit | Baseline, Post-Operative Hours 0, 6, 12, 18, 24, 48, and 72 | Level of hematocrit will be measured at baseline and post-operative. |
| Change in Level of Plasma Free Hemoglobin | Baseline, Post-Operative Hours 0, 6, 12, 18, 24, 48, and 72 | Level of plasma free hemoglobin will be measured at baseline and post-operative. |
| Change in Volume of Blood | Baseline, Post-Processing (Up to 120 Minutes) | Volume of blood will be measured at baseline and post-processing. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Change in Number of Fragmented Red Blood Cells | Baseline, Post-Operative Hours 0, 6, 12, 18, 24, 48, and 72 | Number of fragmented red blood cells will be measured at baseline and post-operative. |
| Time to Wring Sponges | Up to 120 Minutes | Time in seconds to wring sponges will be measured. |
| Change in Level of Lactate Dehydrogenase | Baseline, Post-Operative Hours 0, 6, 12, 18, 24, 48, and 72 | Level of lactate dehydrogenase will be measured at baseline and post-operative. |
| Change in Level of Haptoglobin | Baseline, Post-Operative Hours 0, 6, 12, 18, 24, 48, and 72 | Level of haptoglobin will be measured at baseline and post-operative. |
| Change in Level of Bilirubin | Baseline, Post-Operative Hours 0, 6, 12, 18, 24, 48, and 72 | Level of bilirubin will be measured at baseline and post-operative. |
Countries
United States
Outcome results
None listed