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

Not Applicable

Recruiting

• Conditions: Blood Recovery

• Registration Number: NCT05545930
• Lead Sponsor: University Hospitals Cleveland Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-14
• Study First Submitted QC: 2022-09-14
• Study First Posted: 2022-09-19
• Study Start: 2022-09-20
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-14
• Last Update Posted: 2025-08-20
• Primary Completion: 2026-07-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Level of Plasma Free Hemoglobin	Post-Processing (Up to 120 Minutes)	Level of plasma free hemoglobin will be measured post-processing.
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

Name	Time	Method
Number of Fragmented Red Blood Cells	Post-Processing (Up to 120 Minutes)	Number of fragmented red blood cells will be measured post-processing.
Level of Lactate Dehydrogenase	Post-Processing (Up to 120 Minutes)	Level of lactate dehydrogenase will be measured post-processing.
Time to Wring Sponges	Up to 120 Minutes	Time to wring sponges will be measured.
Level of Haptoglobin	Post-Processing (Up to 120 Minutes)	Level of haptoglobin will be measured post-processing.
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.

Trial Locations

Locations (1)

University Hospitals Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States