Comparing blood recovery methods during heart and lung surgeries
Analysis of Red Blood Cell Integrity and Efficiency of Recovery Using a Novel Surgical Sponge-Blood Recovery Device (ProCell)
This study is testing whether using a machine or doing it by hand is better for recovering blood from sponges during heart and lung surgeries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | University Hospitals Cleveland Medical Center Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT05545930 on ClinicalTrials.gov |
What this trial studies
This research compares two techniques for recovering blood from surgical sponges used in heart and lung surgeries. One method involves manually wringing the sponges by hand, while the other utilizes an FDA-approved automated suction device. Both methods are currently employed at University Hospitals, allowing for a direct comparison of their effectiveness in blood recovery. The study aims to determine which method provides better integrity and efficiency of recovered blood.
Who should consider this trial
Good fit: Ideal candidates are patients undergoing heart or lung transplant, redo sternotomy, aortic surgery, or multi-valve repairs/replacements at University Hospitals Cleveland Medical Center.
Not a fit: Patients with known bleeding disorders or those undergoing emergency surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance blood recovery techniques, leading to improved patient outcomes during heart and lung surgeries.
How similar studies have performed: While similar studies have explored blood recovery methods, this specific comparison of manual versus automated techniques is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Cleveland, Ohio
- University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Rakesh Arora, MD — University Hospitals Cleveland Medical Center
- Study coordinator: Jessica Hungate, MD
- Email: Jessica.Hungate@UHhospitals.org
- Phone: 216-844-3800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.