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

University Hospitals Cleveland Medical Center

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Conditions

Blood Recovery

Interventions

Hand WrungPROCEDURE

Hand wrung refers to manually wringing surgical sponges by hand.

ProCell WrungDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 89 Years

Medical Language ↔ Plain English

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.

Locations (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

Units of Packed Red Blood Cells Transfused

Units of packed red blood cells transfused will be measured.

Time frame: Up to 72 Hours Post-Operative

Change in Level of Hematocrit

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

Time frame: 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.

Time frame: 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.

Time frame: Baseline, Post-Processing (Up to 120 Minutes)

Secondary Outcomes

Change in Number of Fragmented Red Blood Cells

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

Time frame: 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.

Time frame: 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.

Time frame: Baseline, Post-Operative Hours 0, 6, 12, 18, 24, 48, and 72

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.