Surgical Sponge-Blood Recovery Techniques for Blood Transfusion Efficiency

Overseen By Craig Jarrett, MD, MBA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Hospitals Cleveland Medical Center

Disqualifiers: Bleeding disorders, Emergent surgery, Other trials

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Up to 120 minutes

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. ^{1 2 3 4 5}

Why 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. ^{1 3 4 6 7}

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

At University Hospitals Cleveland Medical Center

I am scheduled for or have had heart or lung surgery, including valve repairs.

Exclusion Criteria

I am having emergency or last-resort surgery.

Patients actively participating in another clinical trial which could affect outcomes

I have a known bleeding disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Comparison of two methods of recovering blood from surgical sponges during heart and lung surgeries

Up to 120 minutes

1 visit (in-person)

Follow-up

Participants are monitored for changes in hematocrit, fragmented red blood cells, haptoglobin, bilirubin, and other blood parameters post-operatively

72 hours

Multiple assessments at 0, 6, 12, 18, 24, 48, and 72 hours post-operative

What Are the Treatments Tested in This Trial?

Interventions

• Hand Wrung
• ProCell Wrung

Trial Overview The study compares two blood recovery methods from surgical sponges during heart and lung surgeries: manually squeezing out the blood by hand versus using an FDA-approved automated suction device called ProCell.

How Is the Trial Designed?

Group I: ProCell Wrung Experimental Treatment 1 Intervention

ProCell wrung refers to automated wringing surgical sponges by an FDA approved suction device (ProCell).

Group II: Hand Wrung Active Control 1 Intervention

Hand wrung refers to manually wringing surgical sponges by hand.

Who Is Running the Clinical Trial?

University Hospitals Cleveland Medical Center

Lead Sponsor

Trials

348

Recruited

394,000+

Marc Pelletier

Lead Sponsor

Trials

3

Recruited

270+

ProCell Surgical Inc.

Collaborator

Trials

2

Recruited

20+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05545956

Study Details | NCT05545956 | Analysis of Red Blood Cell ... 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 ...

2. procellsi.com procellsi.com/

ProCell – automated surgical sponge blood recovery The first and only medical device to automate surgical sponge blood recovery for interoperative autotransfusion (IAT) · Optimizes blood conservation · Improves ...

3. sages.org sages.org/publications/tavac/procell-surgical-sponge/

ProCell™ Surgical Sponge – Blood Recovery Unit It may be used in conjunction with standard IAT equipment prior to administering an autologous blood transfusion to the patient.

4. prnewswire.com prnewswire.com/news-releases/procell-surgical-inc-announces-the-launch-of-a-new-proprietary-device-for-blood-conservation-during-surgery-301073869.html

ProCell Surgical Inc. Announces the Launch of a New ... ProCell™ replaces an outdated, manual activity with an automated, more efficient blood collection process. Hand-wringing has several drawbacks, ...

5. uhhospitals.org uhhospitals.org/for-clinicians/articles-and-news/articles/2020/10/uh-becomes-first-hospital-in-us-to-use-new-blood-retrieval-device

UH Becomes First Hospital in US to Use New Blood ... ProCell® enables the patient's surgical team to maximize blood conservation during surgery, leading to an efficient process and potentially ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf19/K193361.pdf

June 1, 2020 ProCell Surgical, Inc. Sharyn Orton Senior ... The recovered blood from ProCell is not intended to be infused directly back into the patient. K193361. Page 5. ProCell™ Surgical Sponge – Blood ...

7. accessgudid.nlm.nih.gov accessgudid.nlm.nih.gov/devices/B890SBRU011

ProCell Surgical Sponge-Blood Recovery Unit (B890SBRU011) ProCell facilitates the extraction of blood from surgical sponges as a preliminary step in the process of cell- salvage/intra-operative autotransfusion (IAT).