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ProCell Wrung for Blood Transfusion

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 up to 120 minutes

Awards & highlights

Study Summary

This trial is testing if there's a difference in the amount of blood recovered when sponges are wrung by hand vs an automated machine.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this trial involves standard procedures rather than new medications, side effects are not the focus but may include typical risks associated with blood transfusion such as allergic reactions or infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 120 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 120 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 120 minutes 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 Volume of Blood

Level of Plasma Free Hemoglobin

Secondary outcome measures

Change in Weight of Surgical Sponge

Level of Haptoglobin

Level of Lactate Dehydrogenase

+2 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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Marc PelletierLead Sponsor

1 Previous Clinical Trials

22 Total Patients Enrolled

ProCell Surgical Inc.UNKNOWN

1 Previous Clinical Trials

22 Total Patients Enrolled

Marc Pelletier, MDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center

1 Previous Clinical Trials

22 Total Patients Enrolled

Media Library

Hand Wrung (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05545930 — N/A

Blood Transfusion Research Study Groups: Hand Wrung, ProCell Wrung

Blood Transfusion Clinical Trial 2023: Hand Wrung Highlights & Side Effects. Trial Name: NCT05545930 — N/A

Hand Wrung (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05545930 — N/A

Frequently Asked Questions

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

Am I eligible to volunteer in this scientific experiment?

"In order to be eligible for this research, individuals must have had blood recovery and be aged 18-89. 12 volunteers are sought in total."

Answered by AI

What are the proposed outcomes of this scientific experiment?

"This clinical trial will evaluate the primary outcome of level of plasma free haemoglobin across baseline and post-processing periods up to 120 minutes. Further, secondary objectives such as change in weight of surgical sponge, amount of fragmented red blood cells, and level of haptoglobin also need to be monitored post-procedure."

Answered by AI

Does this research extend to octogenarians?

"According to the rules of inclusion, individuals aged 18 and over, but not exceeding 89 years old, can take part in this research."

Answered by AI

How many participants are being evaluated in this research project?

"Affirmative, the clinicaltrials.gov portal suggests that this medical experiment is still enrolling patients. Initially posted on September 20th 2022 and recently updated on October 26th 2022, it requires 12 volunteers to be recruited from a single centre."

Answered by AI

Is this research endeavor actively seeking out new participants?

"Affirmative. The data posted on clinicaltrials.gov affirms that this medical trial, initially uploaded on September 20th 2022, is still actively recruiting participants. At present, 12 patients must be sourced from a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Analysis of Red Blood Cell Integrity and Efficiency of Recovery Using a Novel Surgical Sponge-Blood Recovery Device (ProCell): Immediate Impact

Marc Pelletier 2022. "Analysis of Red Blood Cell Integrity and Efficiency of Recovery Using a Novel Surgical Sponge-Blood Recovery Device (ProCell): Immediate Impact". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05545930.