Analysis of Red Blood Cell Integrity and Efficiency of Recovery Using a Novel Surgical Sponge-Blood Recovery Device (ProCell)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Level of Plasma Free Hemoglobin
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Supportive Care
- Masking
- Single (Participant)
Masking Description
Subjects will be blinded to the order of intervention.
Eligibility Criteria
- Ages
- 18 Years to 89 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Hand Wrung
Hand wrung refers to manually wringing surgical sponges by hand.
Intervention: Hand Wrung (Procedure)
ProCell Wrung
ProCell wrung refers to automated wringing surgical sponges by an FDA approved suction device (ProCell).
Intervention: ProCell Wrung (Device)
Outcomes
Primary Outcomes
Level of Plasma Free Hemoglobin
Time Frame: Post-Processing (Up to 120 Minutes)
Level of plasma free hemoglobin will be measured post-processing.
Change in Volume of Blood
Time Frame: Baseline, Post-Processing (Up to 120 Minutes)
Volume of blood will be measured at baseline and post-processing.
Level of Plasma Free Hemoglobin
Time Frame: Baseline
Level of plasma free hemoglobin will be measured at baseline.
Secondary Outcomes
- Number of Fragmented Red Blood Cells(Post-Processing (Up to 120 Minutes))
- Level of Lactate Dehydrogenase(Post-Processing (Up to 120 Minutes))
- Time to Wring Sponges(Up to 120 Minutes)
- Level of Haptoglobin(Post-Processing (Up to 120 Minutes))
- Change in Weight of Surgical Sponge(Baseline, Post-Procedure (Up to 5 Minutes))
- Number of Fragmented Red Blood Cells(Baseline)
- Level of Lactate Dehydrogenase(Baseline)
- Level of Haptoglobin(Baseline)
Investigators
Mohammad El Diasty
Division Chief, Cardiac Surgery, UH Cleveland Medical Center
University Hospitals Cleveland Medical Center