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

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
University Hospitals Cleveland Medical Center
Study ID
NCT05545930
Status
Recruiting

Conditions

  • Blood Recovery

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • Hand Wrung — PROCEDURE
    Hand wrung refers to manually wringing surgical sponges by hand.
  • ProCell Wrung — DEVICE
    ProCell wrung refers to automated wringing surgical sponges by an FDA approved suction device (ProCell).

Study Details

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.

Key Dates

Start date
Sep 20, 2022
Status verified
Jan 2026
Primary completion
Jul 1, 2026
Completion
Jul 1, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE

Arms

  • Active Comparator: Hand Wrung
    Hand wrung refers to manually wringing surgical sponges by hand.
  • Experimental: ProCell Wrung
    ProCell wrung refers to automated wringing surgical sponges by an FDA approved suction device (ProCell).

Primary Outcome Measure

Level of Plasma Free Hemoglobin [ Time Frame: Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University Hospitals Cleveland Medical CenterClevelandOhio44106
Craig Jarrett, MD, MBA
216-286-7297

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