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

NCT ID: NCT05545956

Last Updated: 2024-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-09

Study Completion Date

2025-01-01

Brief Summary

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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

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Conditions

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Blood Recovery

Keywords

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Open Heart Surgery Heart Transplant Lung Transplant ProCell

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants
Subjects will be blinded to the intervention.

Study Groups

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Hand Wrung

Hand wrung refers to manually wringing surgical sponges by hand.

Group Type ACTIVE_COMPARATOR

Hand Wrung

Intervention Type PROCEDURE

Hand wrung refers to manually wringing surgical sponges by hand.

ProCell Wrung

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

Group Type EXPERIMENTAL

ProCell Wrung

Intervention Type DEVICE

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

Interventions

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Hand Wrung

Hand wrung refers to manually wringing surgical sponges by hand.

Intervention Type PROCEDURE

ProCell Wrung

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ProCell Surgical Inc.

UNKNOWN

Sponsor Role collaborator

University Hospitals Cleveland Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marc Pelletier, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Craig Jarrett, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Locations

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University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY20220888_2

Identifier Type: -

Identifier Source: org_study_id