NCT05545930 Analysis of Red Blood Cell Integrity and Efficiency of Recovery Using a Novel Surgical Sponge-Blood Recovery Device (ProCell)
| NCT ID | NCT05545930 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospitals Cleveland Medical Center |
| Condition | Blood Recovery |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2022-09-20 |
| Primary Completion | 2027-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2022-09-20 with a primary completion date of 2027-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Rakesh Arora, MD
PRINCIPAL INVESTIGATOR
University Hospitals Cleveland Medical Center
Frequently Asked Questions
Who can join the NCT05545930 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 89 Years, studying Blood Recovery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05545930 currently recruiting?
Yes, NCT05545930 is actively recruiting participants. Contact the research team at Jessica.Hungate@UHhospitals.org for enrollment information.
Where is the NCT05545930 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT05545930 clinical trial?
NCT05545930 is sponsored by University Hospitals Cleveland Medical Center. The principal investigator is Rakesh Arora, MD at University Hospitals Cleveland Medical Center. The trial plans to enroll 20 participants.