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

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.

Study Overview

• Status: Recruiting
• Conditions: Blood Recovery
• Intervention / Treatment: Procedure: Hand Wrung; Device: ProCell Wrung

• Study Type: Interventional
• Enrollment (Estimated): 22
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Craig Jarrett, MD, MBA; Phone Number: 216-286-7297; Email: Craig.Jarrett@UHhospitals.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • University Hospitals Cleveland Medical Center
      • Contact: Craig Jarrett, MD, MBA; Phone Number: 216-286-7297; Email: Craig.Jarrett@UHhospitals.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Undergoing heart or lung transplant, redo sternotomy, aortic surgery, and/or multi-valve repairs/replacements; and
• At University Hospitals Cleveland Medical Center.

Exclusion Criteria:

• Patients with known bleeding disorders, including disseminated intravascular coagulation (DIC), prothrombin deficiency, factor V deficiency, factor VII deficiency, factor X deficiency, factor XI deficiency (hemophilia C), Glanzmann disease, hemophilia A, hemophilia B, idiopathic thrombocytopenic purpura (ITP), and Von Willebrand disease (types I, II, and III);
• Patients undergoing emergent or emergent salvage surgery; and
• Patients actively participating in another clinical trial which could affect outcomes.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Hand Wrung; Hand wrung refers to manually wringing surgical sponges by hand.	Procedure: Hand Wrung; Hand wrung refers to manually wringing surgical sponges by hand.
Experimental: ProCell Wrung; ProCell wrung refers to automated wringing surgical sponges by an FDA approved suction device (ProCell).	Device: ProCell Wrung; ProCell wrung refers to automated wringing surgical sponges by an FDA approved suction device (ProCell).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Units of Packed Red Blood Cells Transfused	Units of packed red blood cells transfused will be measured.	Up to 72 Hours Post-Operative
Change in Level of Hematocrit	Level of hematocrit will be measured at baseline and post-operative.	Baseline, Post-Operative Hours 0, 6, 12, 18, 24, 48, and 72
Change in Level of Plasma Free Hemoglobin	Level of plasma free hemoglobin will be measured at baseline and post-operative.	Baseline, Post-Operative Hours 0, 6, 12, 18, 24, 48, and 72
Change in Volume of Blood	Volume of blood will be measured at baseline and post-processing.	Baseline, Post-Processing (Up to 120 Minutes)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Number of Fragmented Red Blood Cells	Number of fragmented red blood cells will be measured at baseline and post-operative.	Baseline, Post-Operative Hours 0, 6, 12, 18, 24, 48, and 72
Change in Level of Lactate Dehydrogenase	Level of lactate dehydrogenase will be measured at baseline and post-operative.	Baseline, Post-Operative Hours 0, 6, 12, 18, 24, 48, and 72
Change in Level of Haptoglobin	Level of haptoglobin will be measured at baseline and post-operative.	Baseline, Post-Operative Hours 0, 6, 12, 18, 24, 48, and 72
Change in Level of Bilirubin	Level of bilirubin will be measured at baseline and post-operative.	Baseline, Post-Operative Hours 0, 6, 12, 18, 24, 48, and 72
Change in Weight of Surgical Sponge	Weight of surgical sponges will be measured at baseline and post-procedure.	Baseline, Post-Procedure (Up to 5 Minutes)
Time to Wring Sponges	Time in seconds to wring sponges will be measured.	Up to 120 Minutes

Collaborators and Investigators

• Sponsor: Marc Pelletier
• Collaborators: ProCell Surgical Inc.
• Investigators: Principal Investigator: Marc Pelletier, MD, University Hospitals Cleveland Medical Center; Principal Investigator: Craig Jarrett, MD, MBA, University Hospitals Cleveland Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2023
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: September 14, 2022
• First Submitted That Met QC Criteria: September 14, 2022
• First Posted (Actual): September 19, 2022

Study Record Updates

• Last Update Posted (Estimated): December 15, 2023
• Last Update Submitted That Met QC Criteria: December 14, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Heart Transplant; Open Heart Surgery; Lung Transplant; ProCell
• Other Study ID Numbers: STUDY20220888_2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No