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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
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
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, post-operative hours 0, 6, 12, 18, 24, 48, and 72
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, post-operative hours 0, 6, 12, 18, 24, 48, and 72
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 moreSecondary outcome measures
Change in Level of Bilirubin
Haptoglobins
Change in Level of Lactate Dehydrogenase
+3 moreTrial 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.
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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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am scheduled for or have had heart or lung surgery, including valve repairs.I am having emergency or last-resort surgery.I have a known bleeding disorder.
Research Study Groups:
This trial has the following groups:- Group 1: Hand Wrung
- Group 2: ProCell Wrung
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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