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Recruiting NCT05545930

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

No phase Interventional Blood Recovery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hand Wrung, ProCell Wrung.
Who it may be relevant to
Registry conditions: Blood Recovery. Basic parameters: 18 years — 89 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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.

Interventions

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

Primary outcome measures

  • Level of Plasma Free Hemoglobin [Time frame: Baseline]
  • Level of Plasma Free Hemoglobin [Time frame: Post-Processing (Up to 120 Minutes)]
  • Change in Volume of Blood [Time frame: Baseline, Post-Processing (Up to 120 Minutes)]
Secondary outcome measures (8)
  • Number of Fragmented Red Blood Cells [Time frame: Baseline]
  • Number of Fragmented Red Blood Cells [Time frame: Post-Processing (Up to 120 Minutes)]
  • Level of Lactate Dehydrogenase [Time frame: Baseline]
  • Level of Lactate Dehydrogenase [Time frame: Post-Processing (Up to 120 Minutes)]
  • Level of Haptoglobin [Time frame: Baseline]
  • Level of Haptoglobin [Time frame: Post-Processing (Up to 120 Minutes)]
  • Change in Weight of Surgical Sponge [Time frame: Baseline, Post-Procedure (Up to 5 Minutes)]
  • Time to Wring Sponges [Time frame: Up to 120 Minutes]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Crossover
Masking
Single blind
Primary purpose
Supportive care

Study locations

United States · 1 center
  • University Hospitals Cleveland Medical Center — Cleveland

Identifiers

NCT: NCT05545930 · STUDY20220888

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗