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

• Sponsor: Marc Pelletier (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05545956
• Collaborator: ProCell Surgical Inc. (Other)
• Enrollment: 22
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 3.4
• Patients Per Site Per Month: 6.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Blood Recovery	Procedure: Hand Wrung; Device: ProCell Wrung	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 22 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Masking Description: Subjects will be blinded to the intervention.
• Primary Purpose: Supportive Care
• Official Title: Analysis of Red Blood Cell Integrity and Efficiency of Recovery Using a Novel Surgical Sponge-Blood Recovery Device (ProCell): Delayed Impact
• Anticipated Study Start Date: Oct 19, 2022
• Anticipated Primary Completion Date: Jan 31, 2023
• Anticipated Study Completion Date: Jan 31, 2023

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

1. Units of Packed Red Blood Cells Transfused [Up to 72 Hours Post-Operative]

   Units of packed red blood cells transfused will be measured.

2. Change in Level of Hematocrit [Baseline, Post-Operative Hours 0, 6, 12, 18, 24, 48, and 72]

   Level of hematocrit will be measured at baseline and post-operative.

3. Change in Level of Plasma Free Hemoglobin [Baseline, Post-Operative Hours 0, 6, 12, 18, 24, 48, and 72]

   Level of plasma free hemoglobin will be measured at baseline and post-operative.

4. Change in Volume of Blood [Baseline, Post-Processing (Up to 120 Minutes)]

   Volume of blood will be measured at baseline and post-processing.

Secondary Outcome Measures

1. Change in Number of Fragmented Red Blood Cells [Baseline, Post-Operative Hours 0, 6, 12, 18, 24, 48, and 72]

   Number of fragmented red blood cells will be measured at baseline and post-operative.

2. Change in Level of Lactate Dehydrogenase [Baseline, Post-Operative Hours 0, 6, 12, 18, 24, 48, and 72]

   Level of lactate dehydrogenase will be measured at baseline and post-operative.

3. Change in Level of Haptoglobin [Baseline, Post-Operative Hours 0, 6, 12, 18, 24, 48, and 72]

   Level of haptoglobin will be measured at baseline and post-operative.

4. Change in Level of Bilirubin [Baseline, Post-Operative Hours 0, 6, 12, 18, 24, 48, and 72]

   Level of bilirubin will be measured at baseline and post-operative.

5. Change in Weight of Surgical Sponge [Baseline, Post-Procedure (Up to 5 Minutes)]

   Weight of surgical sponges will be measured at baseline and post-procedure.

6. Time to Wring Sponges [Up to 120 Minutes]

   Time in seconds to wring sponges will be measured.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 89 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospitals Cleveland Medical Center	Cleveland	Ohio	United States	44106

Sponsors and Collaborators

• Marc Pelletier
• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Marc Pelletier, Division Chief, Cardiac Surgery, UH Cleveland Medical Center, University Hospitals Cleveland Medical Center
• ClinicalTrials.gov Identifier: NCT05545956
• Other Study ID Numbers: STUDY20220888_2
• First Posted: Sep 19, 2022
• Last Update Posted: Sep 19, 2022
• Last Verified: Sep 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Marc Pelletier, Division Chief, Cardiac Surgery, UH Cleveland Medical Center, University Hospitals Cleveland Medical Center: Open Heart Surgery; Heart Transplant; Lung Transplant; ProCell

Study Results

No Results Posted as of Sep 19, 2022