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HemOx Transfusion Trial

29. juni 2026 opdateret af: Medical University Innsbruck

Efficacy of Hemoglobin Oxygen Transport in Patients Receiving Intraoperative Cell Salvage vs. Packed Red Blood Cell Units - a Randomized Controlled Pilot Trial

The proposed project, entitled "HemOx Transfusion Study", investigates the functionality of red blood cells (erythrocytes) in the context of oxygen transport in the blood. Erythrocytes contain haemoglobin, a protein responsible for oxygen transport in the bloodstream. Haemoglobin can bind up to four oxygen molecules. This haemoglobin-oxygen binding is particular and efficient, allowing oxygen to be taken up easily in the lungs and released just as readily in oxygen-consuming tissues. In this way, large amounts of oxygen can be transported rapidly and efficiently despite its low solubility in blood. If a patient suffers significant blood loss, for example during surgery, the amount of oxygen-transporting haemoglobin molecules may become so low that a transfusion (administration) of packed red blood cells from a blood donor becomes necessary. In major surgical procedures, which are more frequently associated with blood transfusions, special devices are used to process blood lost from the surgical site and reinfuse it into the same patient. During the storage of packed red blood cells, storage-related damage to the erythrocytes occurs, affecting their shape and functionality. In particular, the haemoglobin-oxygen binding is impaired; the binding affinity increases markedly during storage as a result of metabolic changes within the erythrocytes. This study therefore aims to investigate whether these storage-related changes in packed red blood cells, compared with processed autologous blood from the patient, normalise again after administration in the body, and over what period of time. The rejuvenation of haemoglobin-oxygen binding functionality and oxygen transport capacity of transfused blood is critical for the patient. Understanding the dynamics of this process is intended to inform clinicians about the efficiency of their interventions and to stimulate further research. The intraoperative processing of autologous blood will be examined and analysed in comparison with the administration of packed red blood cells. In this way, the clinical value of processed autologous blood will be evaluated in comparison with packed red blood cells. In the longer term, the processing and/or optimisation of packed red blood cells prior to administration could improve patient care.

Studieoversigt

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

418

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

    • Tyrol
      • Innsbruck, Tyrol, Østrig, 6020

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

Inclusion Criteria:

  1. Understands and agrees to comply with the study procedures and provides written informed consent as documented by signature.
  2. Female and male subjects ≥ 18 years of age at time of consent.
  3. Patient undergoes elective surgery according to Surgery List in Protocol Appendix and blood transfusion is likely to happen at the discretion of the investigator.

    Inclusion criterion 4 only refers to WOCBP

  4. Negative urine pregnancy test, not breastfeeding

Exclusion Criteria:

  1. Known hemoglobinopathy
  2. Indication for irradiation of blood products
  3. preoperative Anemia (Hb <11 mg/dl for women and Hb <12 mg/dl for men)
  4. Contraindication for intraoperative cell salvage (septic surgery, tumor surgery)
  5. Contraindication for transesophageal Doppler ultrasound (craniofacial dysplasia or fracture, history of esophageal perforation or rupture, esophageal stricture, esophageal varices)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Packed Red Blood Cells
transfusion of packed red blood cells units as comparator for Cellsaverblood
Eksperimentel: Cellsaverblood
Cellsaverblood from intraoperative cell salvage versus packed red blood cell units

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
P50 (half pressure of hemoglobin oxygen saturation)
Tidsramme: 10 min post transfusion (time point C)
10 min post transfusion (time point C)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. oktober 2026

Primær færdiggørelse (Anslået)

1. september 2028

Studieafslutning (Anslået)

1. september 2028

Datoer for studieregistrering

Først indsendt

22. juni 2026

Først indsendt, der opfyldte QC-kriterier

29. juni 2026

Først opslået (Faktiske)

30. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 2026-0322-St
  • KLP1227025 (Andet bevillings-/finansieringsnummer: FWF)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Data underpinning research papers will be made available for reuse in repository "ZENODO" at the time of the publication of the article with CC-BY 4.0 licence.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Blødning som kirurgisk komplikation (behandling)

Kliniske forsøg med packed red blood cells

3
Abonner