NCT05798130

Brief Summary

Restrictive and liberal approaches to hemoglobin targets are used when deciding on red blood cell transfusions in patients who do not have acute bleeding and have a hemodynamically stable course in the intensive care unit. However, physiologic trigger points that assess tissue oxygenation when deciding on blood transfusion in patients are also among the important topics of study in recent years. In this study, the investigators will evaluate the oxygen extraction rate, which is an important indicator of the balance between tissue oxygen delivery and consumption. Whether oxygen extraction rate can be used as a trigger for blood transfusion will be determined by clinical outcomes in ICU patients. If physiologic transfusion targets are feasible, the risks of unnecessary transfusions can be avoided with individualized targets, and the decision to transfuse blood can be made without delay in patients requiring red blood cell transfusion.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2023

Completed
29 days until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 4, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

March 12, 2024

Status Verified

November 1, 2023

Enrollment Period

6 months

First QC Date

March 3, 2023

Last Update Submit

March 7, 2024

Conditions

Red Blood Cell TransfusionOxygen Consumption

Outcome Measures

Primary Outcomes (1)

  • Percentage change in oxygen extraction rate

    Evaluate the percentage change in oxygen extraction rate after and before red blood cell transfusion between the two groups with oxygen extraction rates of \> 30% and ≥30%.

    After transfusion of 15.minutes

Secondary Outcomes (6)

  • 7, 28 and 90 days mortality

    7, 28 and 90 days

  • Near infrared spectroscopy values change

    After transfusion of 15.minutes

  • Length of ICU stay

    up to 90 days

  • Complication rates

    up to 90 days

  • Length of hospital stay

    up to 90 days

  • +1 more secondary outcomes

Study Arms (2)

Oxygen Extraction Rate < 30% Group

Oxygen Extraction Rate \< 30%

Other: No intervention group.

Oxygen Extraction Rate ≥ 30% Group

Oxygen Extraction Rate ≥ 30%

Other: No intervention group.

Interventions

No intervention group.OTHER

No intervention group.

Oxygen Extraction Rate < 30% GroupOxygen Extraction Rate ≥ 30% Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Intensive care unit patients

You may qualify if:

  • Patients over 18 years old
  • Patients followed in the intensive care unit for at least 24 hours
  • Patients with central venous catheters
  • Patients who have received a decision to transfuse red blood cells

You may not qualify if:

  • Patients with hemodynamically unstable
  • Patients with acute bleeding
  • Patients in hemorrhagic shock
  • Patients with acute traumatic brain injury
  • Pregnant patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Izmir Katip Celebi University Ataturk Training and Research Hospital, Department of Anesthesiology and Reanimation

Izmir, 35360, Turkey (Türkiye)

Location

Related Publications (3)

  • Orlov D, O'Farrell R, McCluskey SA, Carroll J, Poonawala H, Hozhabri S, Karkouti K. The clinical utility of an index of global oxygenation for guiding red blood cell transfusion in cardiac surgery. Transfusion. 2009 Apr;49(4):682-8. doi: 10.1111/j.1537-2995.2008.02022.x.

    PMID: 19347976BACKGROUND

  • Tuzen AS, Aksun M, Sencan A, Girgin S, Golboyu BE, Kirbas G, Sanli O. Assessment of oxygen extraction rate changes following red blood cell transfusion in the intensive care unit: A prospective observational noninterventional study. Transfusion. 2025 May;65(5):863-875. doi: 10.1111/trf.18164. Epub 2025 Mar 25.

    PMID: 40134137DERIVED

  • Tuzen AS, Aksun M, Sencan A, Girgin S, Golboyu BE, Kirbas G, Sanli O. Assessment of oxygen extraction rate changes following red blood cell transfusion in the intensive care unit: a protocol for a prospective observational non-interventional study. BMJ Open. 2023 Aug 30;13(8):e074413. doi: 10.1136/bmjopen-2023-074413.

    PMID: 37648379DERIVED

Study Officials

  • Ahmet Salih Tüzen

    Izmir Katip Celebi University Ataturk Training and Research Hospital, Department of Anesthesiology and Reanimation

    PRINCIPAL INVESTIGATOR

  • Murat Aksun

    Izmir Katip Celebi University Ataturk Training and Research Hospital, Department of Anesthesiology and Reanimation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

March 3, 2023

First Posted

April 4, 2023

Study Start

April 1, 2023

Primary Completion

September 30, 2023

Study Completion

December 30, 2023

Last Updated

March 12, 2024

Record last verified: 2023-11

Locations

TU(1)