ProCell Wrung for Blood Transfusion

Overseen By Craig Jarrett, MD, MBA

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

Trial Summary

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 data supports the idea that ProCell Wrung for Blood Transfusion is an effective treatment?

The available research shows that ProCell Wrung, which involves hand wringing sponges to recover blood, is effective in salvaging red blood cells. One study found that the amount of blood recovered by hand wringing was similar to that obtained using a spinning device, which suggests that ProCell Wrung is a viable method for blood recovery. Another study demonstrated that blood lost in sponges can be recovered and used to increase the available blood for transfusion, reducing the need for donor blood. This indicates that ProCell Wrung is effective in increasing the amount of usable blood during surgeries. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment ProCell Wrung for blood transfusion?

Research shows that using a spinning device to recover blood from surgical sponges can effectively salvage red blood cells, similar to hand wringing, which suggests that ProCell Wrung could be effective in recovering blood for transfusion. Additionally, studies indicate that blood recovered from sponges can significantly reduce the need for donor blood, supporting the potential effectiveness of this treatment. ^{1 2 3 4 5}

What safety data exists for ProCell Wrung in blood transfusion?

The provided research does not directly mention ProCell Wrung or its variants. However, it discusses the safety and complications associated with autotransfusion systems and cell washing in blood transfusion. The studies highlight concerns about coagulopathic and septic complications in autotransfusion, the potential benefits of cell washing in reducing inflammation and organ injury, and the effects of washing on platelet activation. These insights may be relevant to understanding the safety profile of ProCell Wrung if it involves similar processes. ^{4 6 7 8 9}

Is ProCell Wrung safe for use in blood transfusions?

Research on similar blood washing systems suggests that washing blood cells can help reduce complications like inflammation and organ injury during transfusions. However, washing can also increase the activation of platelets, which might lead to other issues, so the safety of ProCell Wrung may depend on the specific context and patient condition. ^{4 6 7 8 9}

Is the treatment ProCell Wrung promising for blood transfusion?

Yes, ProCell Wrung is a promising treatment for blood transfusion because it helps recover blood cells from surgical wounds, reducing the need for donor blood. It is considered safe and easy to use, making it a valuable option in medical settings. ^{10 11 12 13 14}

How is the ProCell Wrung treatment different from other blood transfusion treatments?

The ProCell Wrung treatment is unique because it involves manually wringing out blood from surgical sponges to recover red blood cells, unlike traditional methods that use machines to process blood. This manual approach may be more accessible in settings where advanced equipment is unavailable. ^{10 11 12 13 14}

What is the purpose of this trial?

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.

Research Team

Marc Pelletier, MD

Principal Investigator

University Hospitals Cleveland Medical Center

Craig Jarrett, MD, MBA

Principal Investigator

University Hospitals Cleveland Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Improving autologous blood harvest: recovery of red cells from sponges and suction. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Surgical sponge blood salvage spinning device design and testing. [2019]

3. France pubmed.ncbi.nlm.nih.gov

Quality of red blood cells using autotransfusion devices: a comparative analysis. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Autotransfusion in trauma: a comparison of two systems. [2006]

5. United States pubmed.ncbi.nlm.nih.gov

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

6. United States pubmed.ncbi.nlm.nih.gov

Platelet activity in washed platelet concentrates. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Bedside Allogeneic Erythrocyte Washing with a Cell Saver to Remove Cytokines, Chemokines, and Cell-derived Microvesicles. [2022]

8. England 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. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Plateletpheresis: what's new? [2005]

10. United States pubmed.ncbi.nlm.nih.gov

Autotransfusion machines. [2007]

11. Italy pubmed.ncbi.nlm.nih.gov

Red blood cell salvage analysis from clotted blood. [2020]

12. United States pubmed.ncbi.nlm.nih.gov

Automated intraoperative processing autotransfusion machines. [2007]

13. United States pubmed.ncbi.nlm.nih.gov

Cell salvage in trauma. [2021]

14. New Zealand 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. [2022]