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

Not Applicable

Withdrawn

• Conditions: Blood Recovery
• Interventions: Procedure: Hand Wrung; Device: ProCell Wrung

• Registration Number: NCT05545956
• 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: 2023-05-09
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-19
• Last Update Posted: 2024-12-24
• Primary Completion: 2025-01-01
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 22

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: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hand Wrung	Hand Wrung	Hand wrung refers to manually wringing surgical sponges by hand.
ProCell Wrung	ProCell Wrung	ProCell wrung refers to automated wringing surgical sponges by an FDA approved suction device (ProCell).

Primary Outcome Measures

Name	Time	Method
Units of Packed Red Blood Cells Transfused	Up to 72 Hours Post-Operative	Units of packed red blood cells transfused will be measured.
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.
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.
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
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.
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.
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.
Time to Wring Sponges	Up to 120 Minutes	Time in seconds to wring sponges will be measured.
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.
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