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Surgical Sponge-Blood Recovery Techniques for Blood Transfusion Efficiency

N/A
Recruiting
Led By Marc Pelletier, MD
Research Sponsored by Marc Pelletier
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Undergoing heart or lung transplant, redo sternotomy, aortic surgery, and/or multi-valve repairs/replacements
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, post-operative hours 0, 6, 12, 18, 24, 48, and 72
Awards & highlights

Study Summary

This trial is comparing two ways of getting blood out of sponges used during heart/lung surgeries. One is manually wringing them by hand, the other is using an automated device.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since both manual and automated sponge-wringing are standard practices already used in surgeries, specific side effects aren't mentioned. However, risks may be similar to typical blood transfusion-related complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am scheduled for or have had heart or lung surgery, including valve repairs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, post-operative hours 0, 6, 12, 18, 24, 48, and 72
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, post-operative hours 0, 6, 12, 18, 24, 48, and 72 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Level of Hematocrit
Change in Level of Plasma Free Hemoglobin
Change in Volume of Blood
+1 more
Secondary outcome measures
Change in Level of Bilirubin
Haptoglobins
Change in Level of Lactate Dehydrogenase
+3 more

Trial Design

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 Location

Who is running the clinical trial?

Marc PelletierLead Sponsor
1 Previous Clinical Trials
12 Total Patients Enrolled
ProCell Surgical Inc.UNKNOWN
1 Previous Clinical Trials
12 Total Patients Enrolled
Marc Pelletier, MDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center
1 Previous Clinical Trials
12 Total Patients Enrolled

Media Library

ProCell Wrung Clinical Trial Eligibility Overview. Trial Name: NCT05545956 — N/A
Blood Transfusion Research Study Groups: Hand Wrung, ProCell Wrung
Blood Transfusion Clinical Trial 2023: ProCell Wrung Highlights & Side Effects. Trial Name: NCT05545956 — N/A
ProCell Wrung 2023 Treatment Timeline for Medical Study. Trial Name: NCT05545956 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any individuals aged sixty or over partaking in this research?

"This medical trial is currently recruiting patients who are over 18 years old but below the age of 89."

Answered by AI

Is enrollment to this trial still accessible?

"Data on clinicaltrials.gov has indicated that this trial, which was first posted in October 19th 2022 and last updated on September 14th 2022, is no longer accepting participants. Nevertheless, there are two other ongoing trials actively looking for patients at the current juncture."

Answered by AI

Who qualifies to participate in this scientific experiment?

"This medical trial is enrolling 22 individuals aged 18 to 89 who have undergone blood recovery. Patients must also be fulfilling the following criteria: undergoing heart or lung transplant, redo sternotomy, aortic surgery, and/or multi-valve repairs/replacements at University Hospitals Cleveland Medical Center."

Answered by AI

What is the intended purpose of this research project?

"The principle objective of this study, evaluated over a 72-hour period post-surgery, is to measure the change in hematocrit. Other secondary assessments include tracking changes in weight of surgical sponges, number of fragmented red blood cells and level of lactate dehydrogenase from baseline through operation."

Answered by AI
~9 spots leftby Jan 2025