HemOx Transfusion Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Bleeding as Surgical Complication (Treatment)
• Intervention / Treatment: Drug: packed red blood cells; Device: autologous maschine transfusion - intraoperative cell salvage

• Study Type: Interventional
• Enrollment (Estimated): 418
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Simon Dr; Phone Number: 0043 512 5040; Email: simon.woyke@i-med.ac.at

Study Locations

• Austria
  • Tyrol
    • Innsbruck, Tyrol, Austria, 6020
      • Medical University Innsbruck
      • Contact: Simon Dr; Phone Number: 0043 512 5040; Email: simon.woyke@i-med.ac.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Packed Red Blood Cells	Drug: packed red blood cells; transfusion of packed red blood cells units as comparator for Cellsaverblood
Experimental: Cellsaverblood	Device: autologous maschine transfusion - intraoperative cell salvage; Cellsaverblood from intraoperative cell salvage versus packed red blood cell units

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
P50 (half pressure of hemoglobin oxygen saturation)	10 min post transfusion (time point C)

Collaborators and Investigators

• Sponsor: Medical University Innsbruck

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: June 22, 2026
• First Submitted That Met QC Criteria: June 29, 2026
• First Posted (Actual): June 30, 2026

Study Record Updates

• Last Update Posted (Actual): June 30, 2026
• Last Update Submitted That Met QC Criteria: June 29, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2026-0322-St; KLP1227025 (Other Grant/Funding Number: FWF)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No