Bleeding as Surgical Complication (Treatment)NCT07677150
HemOx Transfusion Trial
A study testing autologous maschine transfusion - intraoperative cell salvage and packed red blood cells in people with Bleeding as Surgical Complication (Treatment), run by Medical University Innsbruck at 1 site in Austria.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bleeding as Surgical Complication (Treatment)
- What is being tested?
- autologous maschine transfusion - intraoperative cell salvage and packed red blood cells
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 418 participants
- Where
- 1 siteAustria
- Study dates
- Oct 2026to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Understands and agrees to comply with the study procedures and provides written informed consent as documented by signature.
- Female and male subjects ≥ 18 years of age at time of consent.
- Patient undergoes elective surgery according to Surgery List in Protocol Appendix and blood transfusion is likely to happen at the discretion of the investigator.
- Negative urine pregnancy test, not breastfeeding
Who cannot join
- Known hemoglobinopathy
- Indication for irradiation of blood products
- preoperative Anemia (Hb <11 mg/dl for women and Hb <12 mg/dl for men)
- Contraindication for intraoperative cell salvage (septic surgery, tumor surgery)
- Contraindication for transesophageal Doppler ultrasound (craniofacial dysplasia or fracture, history of esophageal perforation or rupture, esophageal stricture, esophageal varices)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site
Medical University Innsbruck
Innsbruck, Tyrol, 6020
Simon Dr, 0043 512 5040, simon.woyke@i-med.ac.at
About this study
Official title: 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.
- Being tested
- autologous maschine transfusion - intraoperative cell salvage, packed red blood cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous maschine transfusion - intraoperative cell salvageDevice
Cellsaverblood from intraoperative cell salvage versus packed red blood cell units
packed red blood cellsDrug
transfusion of packed red blood cells units as comparator for Cellsaverblood
| Study group | Role | What they receive |
|---|---|---|
| Packed Red Blood Cells | Active comparator | Not described Receives: Drug: packed red blood cells |
| Cellsaverblood | Experimental | Not described Receives: Device: autologous maschine transfusion - intraoperative cell salvage |
What is being measured
The primary outcome is the main question the study is designed to answer.
P50 (half pressure of hemoglobin oxygen saturation)
Measured: 10 min post transfusion (time point C)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study startOct 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bleeding as Surgical Complication (Treatment)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 418 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07677150
- Sponsor's protocol ID
- 2026-0322-St
- Other IDs
- KLP1227025
- Status last verified
- Jun 2026
- First submitted
- 22 Jun 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Hemoglobin Oxygen Transport in Patients Receiving Intraoperative Cell Salvage vs. Packed Red Blood Cell Units - a Randomized Controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT07677150
- Acronym / sponsor ID
- 2026-0322-St
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 418 participants (estimated)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 30 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Packed Red Blood Cells | Active comparator | Drug: packed red blood cells |
| Cellsaverblood | Experimental | Device: autologous maschine transfusion - intraoperative cell salvage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Understands and agrees to comply with the study procedures and provides written informed consent as documented by signature.
- Female and male subjects ≥ 18 years of age at time of consent.
- Patient undergoes elective surgery according to Surgery List in Protocol Appendix and blood transfusion is likely to happen at the discretion of the investigator.
- Negative urine pregnancy test, not breastfeeding
Key exclusion criteria (5 listed)
- Known hemoglobinopathy
- Indication for irradiation of blood products
- preoperative Anemia (Hb <11 mg/dl for women and Hb <12 mg/dl for men)
- Contraindication for intraoperative cell salvage (septic surgery, tumor surgery)
- Contraindication for transesophageal Doppler ultrasound (craniofacial dysplasia or fracture, history of esophageal perforation or rupture, esophageal stricture, esophageal varices)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| autologous maschine transfusion - intraoperative cell salvageCellsaverblood from intraoperative cell salvage versus packed red blood cell units | Device | Cellsaverblood |
| packed red blood cellstransfusion of packed red blood cells units as comparator for Cellsaverblood | Drug | Packed Red Blood Cells |
Primary outcome
P50 (half pressure of hemoglobin oxygen saturation)
Time frame: 10 min post transfusion (time point C)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Bleeding as Surgical Complication (Treatment)
RecruitingObservational study
Hip Fracture Surgery Timing and Blood Transfusion Risk in Patients on DOACs
Blood Transfusion, Hip Fracture Surgeries
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing autologous maschine transfusion - intraoperative cell salvage and packed red blood cells in people with Bleeding as Surgical Complication (Treatment), run by Medical University Innsbruck at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Simon Dr (0043 512 5040, simon.woyke@i-med.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
P50 (half pressure of hemoglobin oxygen saturation) (time frame: 10 min post transfusion (time point C)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.