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Surgical Sponge-Blood Recovery Techniques for Blood Transfusion Efficiency

CJ
Overseen ByCraig Jarrett, MD, MBA
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University Hospitals Cleveland Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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

MP

Marc Pelletier, MD

Principal Investigator

University Hospitals Cleveland Medical Center

CJ

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 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

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: ProCell WrungExperimental Treatment1 Intervention
ProCell wrung refers to automated wringing surgical sponges by an FDA approved suction device (ProCell).
Group II: Hand WrungActive Control1 Intervention
Hand wrung refers to manually wringing surgical sponges by hand.

Find a Clinic Near You

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+
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