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

University Hospitals (UH)

Status: Enrolling

Conditions: Blood Recovery

Treatments: Procedure: Hand Wrung; Device: ProCell Wrung

Study type: Interventional

Funder types: Other

Identifiers

NCT05545930

STUDY20220888

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Hand Wrung

Active Comparator group

Description:

Hand wrung refers to manually wringing surgical sponges by hand.

Treatment:

Procedure: Hand Wrung

ProCell Wrung

Experimental group

Description:

ProCell wrung refers to automated wringing surgical sponges by an FDA approved suction device (ProCell).

Treatment:

Device: ProCell Wrung