Surgical Sponge-Blood Recovery Techniques for Blood Transfusion Efficiency
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two methods for extracting blood from surgical sponges during heart and lung surgeries. One method involves squeezing the sponges by hand (Hand Wrung), while the other uses a machine called ProCell (ProCell Wrung). Both techniques aim to improve the efficiency of blood recovery and reuse. Patients undergoing heart or lung transplants or complex heart surgeries at University Hospitals Cleveland Medical Center might be suitable candidates. As an unphased trial, this study allows patients to contribute to innovative surgical techniques that could enhance recovery processes.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that these blood recovery methods are safe for use in surgeries?
Studies have shown that the FDA has approved the ProCell device, which automatically squeezes surgical sponges. This approval confirms its safety for its intended use. The device collects blood from surgical sponges during operations and is already used in hospitals, helping to save more blood.
The traditional method of squeezing sponges by hand remains common in surgeries. Both methods are considered safe by medical standards, with no reports of major safety issues. Joining a study that compares these methods involves techniques that doctors already trust.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores innovative techniques to enhance blood transfusion efficiency during surgeries. Unlike the standard practice of manually wringing out surgical sponges, this trial tests an automated method using the FDA-approved ProCell device. This automated approach could improve the precision and consistency of blood recovery, potentially reducing waste and improving patient outcomes. By comparing these methods, researchers hope to find out if the ProCell technique offers a significant advantage over traditional hand-wringing methods.
What evidence suggests that these blood recovery techniques are effective for heart and lung surgeries?
This trial will compare two methods for recovering blood from surgical sponges: the traditional hand-wringing method and the automated ProCell device. Research has shown that the ProCell device can recover more blood during heart and lung surgeries. By automating the process, the device increases efficiency compared to manual hand-wringing. Studies indicate that the ProCell device saves more blood, which is crucial for patients who might need transfusions. While hand-squeezing is the traditional method, it can be inconsistent. The automated ProCell method aims to deliver better and more reliable blood recovery results.13467
Who Is on the Research Team?
Marc Pelletier, MD
Principal Investigator
University Hospitals Cleveland Medical Center
Craig Jarrett, MD, MBA
Principal Investigator
University Hospitals Cleveland Medical Center
Are You a Good Fit for This Trial?
This trial is for patients at University Hospitals Cleveland Medical Center undergoing heart or lung transplants, redo sternotomies, aortic surgeries, or multi-valve repairs/replacements. It's not for those with bleeding disorders like hemophilia or Von Willebrand disease, those in emergency surgeries, or participants in other trials that could affect outcomes.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Comparison of two methods of recovering blood from surgical sponges during heart and lung surgeries
Follow-up
Participants are monitored for changes in hematocrit, fragmented red blood cells, haptoglobin, bilirubin, and other blood parameters post-operatively
What Are the Treatments Tested in This Trial?
Interventions
- Hand Wrung
- ProCell Wrung
Find a Clinic Near You
Who Is Running the Clinical Trial?
University Hospitals Cleveland Medical Center
Lead Sponsor
Marc Pelletier
Lead Sponsor
ProCell Surgical Inc.
Collaborator