AnemiaNCT03767127
Oxygen Extraction-guided Transfusion in Critically Ill Patients
An observational study of Anemia and Critical Illness, run by Università degli Studi di Ferrara at 1 site in Italy.
Trial summary
Anemia is common in intensive care unit (ICU) patients and often appears early in the ICU course. The optimal management red blood cells RBC transfusion in critically ill patients remains controversial and clinical studies in this field have usually been based on transfusion thresholds. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia, Critical Illness
- How many people
- 177 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2017to 30 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Study population: Unselected critically ill patients admitted to intensive care unit
Who may be able to join
- Hemoglobin level <10 g/dL during the first 72 hours of ICU
Who cannot join
- Acute bleeding
- Hemoglobin level less than 7 g/dL
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Red Blood Cell Transfusion Decision Based on Arterial-venous Oxygen Difference Can Reduce Mortality in Critically Ill Patients
Anemia is common in intensive care unit (ICU) patients and often appears early in the ICU course. The optimal management red blood cells RBC transfusion in critically ill patients remains controversial and clinical studies in this field have usually been based on transfusion thresholds. In the "TRICC" Trial, patients assigned to a restrictive transfusion strategy (transfusion if Hb<7 g/dL) had similar mortality to patients transfused if Hb<10 g/dL. Notably, none of the large RCT tried to focus on a personalize RBC transfusion protocol, i.e. a transfusion protocol which address the individual need for transfusion basing on physiological approach. We therefore hypothesized that patients with high extraction of oxygen could benefit more of RBCs transfusion regardless their hemoglobin levels.
- Conditions
- Anemia, Critical Illness
- Keywords
- transfusion, intensive care medicine, 90-day mortality
- Medical subject headings
- Anemia, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Appropriate transfusion policy | Patients transfused with high arterial-venous oxygen difference (≥3.7 ml/dl) or non-transfused with low arterial-venous oxygen difference (<3.7 ml/dl) | |
| Non-Appropriate transfusion policy | Patients transfused despite low arterial-venous oxygen difference or non-transfused with high arterial-venous oxygen difference |
What is being measured
The primary outcome is the main question the study is designed to answer.
90-day mortality
mortality
Measured: after 90 days from study enrollment
Secondary outcomes (4)
Acute kidney injury
Occurence of acute kidney injury according to KDIGO 2012 guidelines
Measured: 7 days after study inclusion
Length of ICU stay
Measured: from ICU admission to discharge, up to 8 weeks
Variation in Sequential Organ Failure Assessment (SOFA) score
daily variation in SOFA score (0-24 points scale with higher values indicating worst conditions)
Measured: 5 days
Days of vasopressor
Need for vasopressor
Measured: 28 days after study inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2018
- Study start1 Jul 2017
- Primary completion1 Oct 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Ferrara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alberto Fogagnolo, Università degli Studi di Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03767127
- Sponsor's protocol ID
- OEDT
- Status last verified
- Nov 2019
- First submitted
- 30 Nov 2018
- Last updated
- 21 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fogagnolo A, Taccone FS, Vincent JL, Benetto G, Cavalcante E, Marangoni E, Ragazzi R, Creteur J, Volta CA, Spadaro S. Using arterial-venous oxygen difference to guide red blood cell transfusion strategy. Crit Care. 2020 Apr 20;24(1):160. doi: 10.1186/s13054-020-2827-5.
PubMed 32312299
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Red Blood Cell Transfusion Decision Based on Arterial-venous Oxygen Difference Can Reduce Mortality in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT03767127
- Acronym / sponsor ID
- OEDT
- Conditions
- Anemia, Critical Illness
- Keywords
- transfusion, intensive care medicine, 90-day mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Università degli Studi di FerraraUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 6 Dec 2018 (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.
Anemia is common in intensive care unit (ICU) patients and often appears early in the ICU course. The optimal management red blood cells RBC transfusion in critically ill patients remains controversial and clinical studies in this field have usually been based on transfusion thresholds. In the "TRICC" Trial, patients assigned to a restrictive transfusion strategy (transfusion if Hb<7 g/dL) had similar mortality to patients transfused if Hb<10 g/dL. Notably, none of the large RCT tried to focus on a personalize RBC transfusion protocol, i.e. a transfusion protocol which address the individual need for transfusion basing on physiological approach. We therefore hypothesized that patients with high extraction of oxygen could benefit more of RBCs transfusion regardless their hemoglobin levels.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Appropriate transfusion policy | – | –Patients transfused with high arterial-venous oxygen difference (≥3.7 ml/dl) or non-transfused with low arterial-venous oxygen difference (<3.7 ml/dl) |
| Non-Appropriate transfusion policy | – | –Patients transfused despite low arterial-venous oxygen difference or non-transfused with high arterial-venous oxygen difference |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Unselected critically ill patients admitted to intensive care unit
Key inclusion criteria (1 listed)
- Hemoglobin level <10 g/dL during the first 72 hours of ICU
Key exclusion criteria (2 listed)
- Acute bleeding
- Hemoglobin level less than 7 g/dL
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
90-day mortality
Time frame: after 90 days from study enrollment
mortality
4 secondary outcomes
Acute kidney injury
Time frame: 7 days after study inclusion
Length of ICU stay
Time frame: from ICU admission to discharge, up to 8 weeks
Variation in Sequential Organ Failure Assessment (SOFA) score
Time frame: 5 days
Days of vasopressor
Time frame: 28 days after study inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2019.
- Derived from this study: PubMed 32312299Fogagnolo A, Taccone FS, Vincent JL, Benetto G, Cavalcante E, Marangoni E, Ragazzi R, Creteur J, Volta CA, Spadaro S. Using arterial-venous oxygen difference to guide red blood cell transfusion strategy. Crit Care. 2020 Apr 20;24(1):160. doi: 10.1186/s13054-020-2827-5.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia and Critical Illness, run by Università degli Studi di Ferrara at 1 site in Italy.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 21 Nov 2019. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
90-day mortality (time frame: after 90 days from study enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03767127, which also lists 1 linked publication.
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 21 Nov 2019.