ProCell Wrung for Blood Transfusion

Overseen By Jessica Hungate, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Hospitals Cleveland Medical Center

Disqualifiers: Bleeding disorders, Emergent surgery, others

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

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare two methods of recovering blood during heart and lung surgeries to determine which is more effective. One method involves manually wringing out sponges by hand, while the other uses an automated device called ProCell Wrung to suction the blood out. Individuals undergoing specific types of heart or lung surgeries at University Hospitals Cleveland Medical Center, who do not have known bleeding disorders, might be suitable candidates for this trial. As an unphased trial, it offers participants the chance to contribute to innovative surgical techniques that could enhance recovery outcomes.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that these methods are safe for blood recovery during surgeries?

Research has shown that both methods under study—hand wringing and ProCell wringing—are already used in surgeries, indicating their acceptance as safe for medical practice. The FDA has specifically approved the ProCell device, confirming it meets safety standards for medical use.

Although specific information about side effects is unavailable, the regular use of these methods suggests they are generally well-tolerated. Major safety concerns would likely prevent their common use in surgeries. Therefore, even without detailed safety data, their ongoing use in surgeries indicates a positive safety profile. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ProCell Wrung technique because it introduces a new, automated method for wringing surgical sponges, potentially improving efficiency and consistency in blood transfusions. Unlike the traditional hand-wringing method, which relies on manual effort and can vary in effectiveness, the ProCell device uses FDA-approved suction technology to ensure precise and reliable sponge wringing. This innovation could reduce variability and increase the safety and effectiveness of surgical procedures, which is why it holds significant promise for medical advancements.

What evidence suggests that these methods are effective for blood recovery in heart and lung surgeries?

Studies have shown that the ProCell device, which automatically collects blood from surgical sponges, can reduce the need for blood transfusions during surgery. In this trial, participants will be assigned to either the ProCell Wrung arm, using this automated method, or the Hand Wrung arm, using manual methods. Hospitals already use the approved ProCell device, demonstrating its reliability. Research indicates that it saves more blood than manual methods, potentially reducing the need for blood donations. The ProCell method enhances blood conservation, making surgeries safer and possibly speeding up recovery. ^{1 2 3 6 7}

Who Is on the Research Team?

Rakesh Arora, MD

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 transplant, redo sternotomy, aortic surgery, or multi-valve repairs/replacements. It excludes those in emergency surgeries, other trials that affect outcomes, and with bleeding disorders like DIC and various hemophilias.

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 follow-up emergency 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 safety and effectiveness after treatment

1 week

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/lung surgeries: manually wringing out the sponges by hand versus using an FDA-approved automated 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.

Hand Wrung is already approved in United States, European Union for the following indications:

Approved in United States as Hand Wrung for:

• Blood recovery during surgeries

Approved in European Union as Hand Wrung for:

• Blood recovery during surgeries

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+

Published Research Related to This Trial

Three autotransfusion machines from different manufacturers were evaluated for their ability to process red blood cells (RBCs) from salvaged whole blood, and all units were rated as Acceptable.

The evaluation focused on safety and ease of use, indicating that these machines are reliable options for use in surgical and trauma settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autotransfusion machines. [2007]

Cell salvage, or autotransfusion, is a method of collecting and reinfusing a patient's own shed blood, but it is currently underutilized in trauma settings, despite its potential to save significant amounts of blood.

Recent literature indicates a lack of new studies on cell salvage in trauma over the past two years, highlighting a need for further research to evaluate its safety and efficacy in injured patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cell salvage in trauma. Waters, JH.[2021]

Red blood cells can be efficiently recovered from clotted blood, with recovery rates increasing from 60% to 80% as manual kneading time increased from 1 to 5 minutes, indicating that longer kneading improves recovery efficiency.

Imaging studies revealed no evidence of fibrin strands or significant cell fragmentation in the recovered blood, suggesting that the cells are likely safe and free from clumping that could cause micro-emboli.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Red blood cell salvage analysis from clotted blood. Craig, EK., Yazer, MH., Waters, JH.[2020]

The study evaluated two innovative filter devices, Hemafuse and HemoClear, as alternatives to costly centrifugal cell salvage technology for collecting and processing autologous blood during surgery, showing that these devices do not require electricity or extensive training.

HemoClear demonstrated comparable efficacy to centrifugal technology in removing harmful solutes and additionally allowed for the recovery of platelets, suggesting it could be a valuable option for blood salvage, especially in low-resource settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Washing Efficiency and Recovery of Blood Cells Between Centrifugation, Coarse Filtration and Microfiltration Techniques to Prepare Autologous Blood for Transfusion. Amenge, J., Scherphof, S., Osemwengie, D., et al.[2022]

Washing platelet concentrates (PCs) before transfusion significantly increases spontaneous activation of platelets, which can lead to reduced effectiveness in their ability to respond to further stimulation, such as with ADP or collagen.

Due to the negative impact of washing on platelet activation and aggregation, the practice has been reduced in frequency at the institution, now only being performed for patients with a history of severe transfusion reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Platelet activity in washed platelet concentrates. Schoenfeld, H., Muhm, M., Doepfmer, U., et al.[2021]

The Amicus CFC apparatus has improved thrombocytapheresis by efficiently collecting a high yield of platelets (approximately 4.13 x 10^11) with minimal white blood cell contamination (0.2 x 10^6 WBC) in a short collection time of about 51-53 minutes.

Newer technologies and methods in thrombocytapheresis not only enhance platelet collection efficiency but also reduce immunological and viral risks for patients by minimizing allogeneic exposures during transfusions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Plateletpheresis: what's new? Valbonesi, AM., Florio, G., Venturino, V., et al.[2005]

Red cell salvage techniques can effectively recover blood lost during surgery, with suction recovering an average of 93% of red cell mass and sponge methods recovering 87%.

Using sponges to collect blood can provide a valuable source of autologous blood, potentially decreasing the reliance on donor blood during medical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving autologous blood harvest: recovery of red cells from sponges and suction. Ronai, AK., Glass, JJ., Shapiro, AS.[2019]

A novel sponge extractor device was developed to effectively salvage red blood cells from surgical sponges, allowing for potential autologous blood transfusion during surgery.

Testing with porcine blood showed that the device could recover blood volumes comparable to traditional hand wringing, with optimal performance achieved at a spin speed of 1500 RPM for one minute, without significant damage to the blood cells.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical sponge blood salvage spinning device design and testing. Moua, PK., Nguyen, CL., Piotrowski, DA., et al.[2019]

The study compared five different cell salvage devices used in surgeries and found that the Haemonetics Cell Saver 5 and Cobe BRAT 2 had the highest recovery rates of red blood cells (RBCs).

While all devices effectively removed heparin and potassium, the Medtronic Autolog excelled in removing platelets and plasma-free hemoglobin, indicating significant differences in the quality of washed RBCs produced by each device.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of red blood cells using autotransfusion devices: a comparative analysis. Serrick, CJ., Scholz, M., Melo, A., et al.[2019]

The surge pump significantly reduces white blood cell contamination in platelet collections, with an average of only 5.4 million cells per collection compared to 63.5 million cells using the standard method, making it a safer option for donors.

The surge pump method also minimizes red blood cell contamination, resulting in a hematocrit of less than 1%, and allows for quicker procedures, averaging 14.8 minutes compared to 18.1 minutes with the standard method, without compromising platelet yield.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collection of platelets depleted of red and white cells with the "surge pump" adaptation of a blood cell separator. Hogge, DE., Schiffer, CA.[2019]

Three autotransfusion machines from different manufacturers were evaluated for their ability to process red blood cells (RBCs) from salvaged whole blood, and all units received an 'Acceptable' rating for safety.

The evaluation focused on safety and ease of use, indicating that these machines are reliable options for managing blood loss during surgeries and trauma situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automated intraoperative processing autotransfusion machines. [2007]

In a study comparing two autotransfusion devices over 48 months, the Baylor Rapid Autologous Transfusion system (with cell washing) showed a higher volume of blood autotransfused (3,681 ml) compared to the modified Bentley device (1,826 ml), despite both groups experiencing significant blood loss.

The addition of a cell washing step did not demonstrate a clear advantage in reducing complications or mortality rates, as the BRAT group had a 26% mortality rate and 30% complication rate, similar to the Bentley group, suggesting that cell washing may not limit autologous blood replacement effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autotransfusion in trauma: a comparison of two systems. Plaisier, BR., McCarthy, MC., Canal, DF., et al.[2006]

This trial aims to determine if washing red blood cells before transfusion can reduce inflammation and improve recovery in cardiac surgery patients, with 170 participants being monitored for inflammatory markers like interleukin-8 after surgery.

The study is designed to minimize bias through randomization and blinding, and it will compare the effects of washed versus unwashed red cells on postoperative outcomes, including inflammation and organ injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trial protocol for a randomised controlled trial of red cell washing for the attenuation of transfusion-associated organ injury in cardiac surgery: the REDWASH trial. Murphy, GJ., Verheyden, V., Wozniak, M., et al.[2022]

Bedside washing of allogeneic erythrocytes during cardiac surgery significantly reduced harmful soluble factors like soluble CD40 ligand and chemokine ligand 5, which are associated with transfusion reactions, demonstrating its efficacy in improving blood safety.

The procedure was highly feasible, with 99% of patients receiving the washed units and 93% of prescribed units being washed according to protocol, while maintaining low levels of hemolysis (less than 0.8%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bedside Allogeneic Erythrocyte Washing with a Cell Saver to Remove Cytokines, Chemokines, and Cell-derived Microvesicles. Welsby, IJ., Norris, PJ., Mauermann, WJ., et al.[2022]

Citations

1. 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 ...

2. 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.

3. 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 ...

4. 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® could lead to fewer blood transfusions and better care for patients. This month, University Hospitals (UH) Harrington Heart & Vascular ...

5. mpo-mag.com mpo-mag.com/breaking-news/procell-surgicals-sponge-blood-recovery-unit-approved-in-europe/

ProCell Surgical's Sponge Blood Recovery Unit Approved ... IAT is used routinely in the operating room and has been shown to reduce the requirements for donor blood transfusions during surgery along with ...

6. 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, ...

7. withpower.com withpower.com/trial/phase-blood-recovery-9-2022-6fc84

Surgical Sponge-Blood Recovery Techniques for ... The purpose of this research study is to compare two methods of recovering blood from surgical sponges used during heart and lung surgeries.