Analyse af røde blodlegemers integritet og effektiviteten af restitution ved hjælp af en ny kirurgisk svamp-blod-gendannelsesanordning (ProCell): Øjeblikkelig virkning
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Jessica Hungate, MD
- Telefonnummer: 216-844-3800
- E-mail: Jessica.Hungate@UHhospitals.org
Studiesteder
-
-
Ohio
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Cleveland, Ohio, Forenede Stater, 44106
- Rekruttering
- University Hospitals Cleveland Medical Center
-
Kontakt:
- Craig Jarrett, MD, MBA
- Telefonnummer: 216-286-7297
- E-mail: Craig.Jarrett@UHhospitals.org
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Ikke-randomiseret
- Interventionel model: Crossover opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Hand Wrung
Hand wrung refers to manually wringing surgical sponges by hand. |
Hand wrung refers to manually wringing surgical sponges by hand. |
|
Eksperimentel: ProCell Wrung
ProCell wrung refers to automated wringing surgical sponges by an FDA approved suction device (ProCell). |
ProCell wrung refers to automated wringing surgical sponges by an FDA approved suction device (ProCell). |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Level of Plasma Free Hemoglobin
Tidsramme: Baseline
|
Level of plasma free hemoglobin will be measured at baseline. |
Baseline
|
|
Level of Plasma Free Hemoglobin
Tidsramme: Post-Processing (Up to 120 Minutes)
|
Level of plasma free hemoglobin will be measured post-processing. |
Post-Processing (Up to 120 Minutes)
|
|
Change in Volume of Blood
Tidsramme: Baseline, Post-Processing (Up to 120 Minutes)
|
Volume of blood will be measured at baseline and post-processing. |
Baseline, Post-Processing (Up to 120 Minutes)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Fragmented Red Blood Cells
Tidsramme: Baseline
|
Number of fragmented red blood cells will be measured at baseline. |
Baseline
|
|
Number of Fragmented Red Blood Cells
Tidsramme: Post-Processing (Up to 120 Minutes)
|
Number of fragmented red blood cells will be measured post-processing. |
Post-Processing (Up to 120 Minutes)
|
|
Level of Lactate Dehydrogenase
Tidsramme: Baseline
|
Level of lactate dehydrogenase will be measured at baseline. |
Baseline
|
|
Level of Lactate Dehydrogenase
Tidsramme: Post-Processing (Up to 120 Minutes)
|
Level of lactate dehydrogenase will be measured post-processing. |
Post-Processing (Up to 120 Minutes)
|
|
Level of Haptoglobin
Tidsramme: Baseline
|
Level of haptoglobin will be measured at baseline. |
Baseline
|
|
Level of Haptoglobin
Tidsramme: Post-Processing (Up to 120 Minutes)
|
Level of haptoglobin will be measured post-processing. |
Post-Processing (Up to 120 Minutes)
|
|
Change in Weight of Surgical Sponge
Tidsramme: Baseline, Post-Procedure (Up to 5 Minutes)
|
Weight of surgical sponges will be measured at baseline and post-procedure. |
Baseline, Post-Procedure (Up to 5 Minutes)
|
|
Time to Wring Sponges
Tidsramme: Up to 120 Minutes
|
Time to wring sponges will be measured. |
Up to 120 Minutes
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Rakesh Arora, MD, University Hospitals Cleveland Medical Center
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- STUDY20220888
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
produkt fremstillet i og eksporteret fra U.S.A.
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