Infection After TransfusionNCT02020525

Blood Transfusions and Immune Response

A study testing restrictive transfusion strategy and liberal transfusion strategy in people with Infection After Transfusion and Transfusion-related Immunomodulation Reaction, run by Aretaieion University Hospital at 1 site in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

We have previously reported the results of the primary and secondary outcomes of a randomized study aiming to investigate the impact of a restrictive transfusion protocol on the magnitude of reduction in blood transfusion in a typically mixed general surgery population subjected to major abdominal surgery. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Infection After Transfusion, Transfusion-related Immunomodulation Reaction, Cytokine Storm
What is being tested?: restrictive transfusion strategy and liberal transfusion strategy
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 58 participants
Where: 1 siteGreece
Study dates: Dec 2004to May 2007
Phase: Interventional
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 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adult patients, American Society of Anesthesiologists (ASA) distribution I-III, scheduled for elective upper major abdominal surgery

Who cannot join

history of bleeding diathesis
hereditary hemostatic defects such as hemophilias
chronic anticoagulant administration
refusal of transfusions for religious reasons
ischemic heart disease (unstable angina or myocardial infarction within the last six months)
preexisting infectious diseases
preexisting autoimmune diseases
use of corticosteroids or immunosuppressive drugs within the last six months

Trial locations and contacts

1 site in 1 country.

Greece1 site

Aretaieion University Hospital
Athens, 115 28

Other trials in Greece

About this study

Official title: The Impact of Lowering Transfusion Trigger on Patient Immune Response During Major Abdominal Surgery

We have previously reported the results of the primary and secondary outcomes of a randomized study aiming to investigate the impact of a restrictive transfusion protocol on the magnitude of reduction in blood transfusion in a typically mixed general surgery population subjected to major abdominal surgery.
The main finding of that study was a reduction in red blood cell usage with the implementation of a restrictive transfusion regimen. This was achieved without adversely affecting clinical outcome in the population studied.
The aim of this secondary analysis performed on a subgroup of 20 patients from the original study was to determine whether there are any differences in the postoperative immunologic response, as expressed by the production of inflammatory mediators, between a restrictive approach to red cell transfusion and a more liberal strategy.

Conditions: Infection After Transfusion, Transfusion-related Immunomodulation Reaction, Cytokine Storm, Surgery
Being tested: restrictive transfusion strategy, liberal transfusion strategy
Medical subject headings: Cytokine Release Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

restrictive transfusion strategyProcedure or surgery
Patients allocated to the restrictive transfusion strategy were transfused only when their hemoglobin concentration decreased below 7.7 g d dL-1 and were then maintained at hemoglobin concentrations between 7.7 and 9.9 g d dL-1.
liberal transfusion strategyProcedure or surgery
Patients assigned to the liberal strategy were transfused when their hemoglobin concentration fell below 9.9 g dL-1, aiming at maintaining hemoglobin at or above 10 g dL-1.

Study groups in NCT02020525
Study group	Role	What they receive
restrictive transfusion strategy	Experimental	Patients allocated to the restrictive transfusion strategy were transfused only when their hemoglobin concentration decreased below 7.7 g d dL-1 and were then maintained at hemoglobin concentrations between 7.7 and 9.9 g d dL-1. Receives: Procedure: restrictive transfusion strategy
liberal transfusion strategy	Active comparator	Patients assigned to the liberal strategy were transfused when their hemoglobin concentration fell below 9.9 g dL-1, aiming at maintaining hemoglobin at or above 10 g dL-1. Receives: Procedure: liberal transfusion strategy

What is being measured

The primary outcome is the main question the study is designed to answer.

The number of units transfused per patient as well as the incidence of blood transfusions in each transfusion strategy group (restrictive versus liberal)
Measured: first five postoperative days

Secondary outcomes (4)

time of initial mobilization postoperatively
Measured: first five postoperative days
time of first liquid food intake
Measured: first five postoperative days
time of first solid food intake
Measured: first five postoperative days
incidence of postoperative infectious complications
Measured: first five postoperative days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2004May 2007

First posted25 Dec 2013 (estimated)
Study startDec 2004
Primary completionMay 2007
Study completionMay 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Infection After TransfusionStudies 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: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 58 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02020525
Sponsor's protocol ID: TRANSF-CYTOK
Status last verified: Feb 2019
First submitted: 18 Dec 2013
Last updated: 15 Feb 2019
Results posted: No
Data monitoring committee: Yes

Publications

Baigrie RJ, Lamont PM, Kwiatkowski D, Dallman MJ, Morris PJ. Systemic cytokine response after major surgery. Br J Surg. 1992 Aug;79(8):757-60. doi: 10.1002/bjs.1800790813.
PubMed 1393463
Koch CG, Li L, Sessler DI, Figueroa P, Hoeltge GA, Mihaljevic T, Blackstone EH. Duration of red-cell storage and complications after cardiac surgery. N Engl J Med. 2008 Mar 20;358(12):1229-39. doi: 10.1056/NEJMoa070403.
PubMed 18354101
Vamvakas EC, Blajchman MA. Deleterious clinical effects of transfusion-associated immunomodulation: fact or fiction? Blood. 2001 Mar 1;97(5):1180-95. doi: 10.1182/blood.v97.5.1180. No abstract available.
PubMed 11222359
Leal Noval SR, Jara Lopez I. Do multiple blood transfusions predispose for a higher rate of non-blood-related infection complications? Clin Microbiol Infect. 2002 Jul;8(7):383-7. doi: 10.1046/j.1469-0691.2002.00465.x.
PubMed 12199847
Hebert PC, Wells G, Blajchman MA, Marshall J, Martin C, Pagliarello G, Tweeddale M, Schweitzer I, Yetisir E. A multicenter, randomized, controlled clinical trial of transfusion requirements in critical care. Transfusion Requirements in Critical Care Investigators, Canadian Critical Care Trials Group. N Engl J Med. 1999 Feb 11;340(6):409-17. doi: 10.1056/NEJM199902113400601.
PubMed 9971864
Sherry RM, Cue JI, Goddard JK, Parramore JB, DiPiro JT. Interleukin-10 is associated with the development of sepsis in trauma patients. J Trauma. 1996 Apr;40(4):613-6; discussion 616-7. doi: 10.1097/00005373-199604000-00016.
PubMed 8614042
Bilgin YM, Brand A. Transfusion-related immunomodulation: a second hit in an inflammatory cascade? Vox Sang. 2008 Nov;95(4):261-71. doi: 10.1111/j.1423-0410.2008.01100.x.
PubMed 19138255
Theodoraki K, Markatou M, Rizos D, Fassoulaki A. The impact of two different transfusion strategies on patient immune response during major abdominal surgery: a preliminary report. J Immunol Res. 2014;2014:945829. doi: 10.1155/2014/945829. Epub 2014 Apr 3.
PubMed 24804272

Study at a glance

From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Impact of Lowering Transfusion Trigger on Patient Immune Response During Major Abdominal Surgery
ClinicalTrials.gov ID: NCT02020525
Acronym / sponsor ID: TRANSF-CYTOK
Conditions: Infection After Transfusion, Transfusion-related Immunomodulation Reaction, Cytokine Storm, Surgery
Study type: Interventional
Recruitment status: Completed
Enrolment: 58 participants (actual)
Lead sponsor: Aretaieion University HospitalUniversity, hospital or other
Study start: Dec 2004
Primary completion: May 2007 (actual)
Study completion: May 2007 (actual)
First posted: 25 Dec 2013 (estimated)
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.

We have previously reported the results of the primary and secondary outcomes of a randomized study aiming to investigate the impact of a restrictive transfusion protocol on the magnitude of reduction in blood transfusion in a typically mixed general surgery population subjected to major abdominal surgery.
The main finding of that study was a reduction in red blood cell usage with the implementation of a restrictive transfusion regimen. This was achieved without adversely affecting clinical outcome in the population studied.
The aim of this secondary analysis performed on a subgroup of 20 patients from the original study was to determine whether there are any differences in the postoperative immunologic response, as expressed by the production of inflammatory mediators, between a restrictive approach to red cell transfusion and a more liberal strategy.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
restrictive transfusion strategy	Experimental	Procedure: restrictive transfusion strategyPatients allocated to the restrictive transfusion strategy were transfused only when their hemoglobin concentration decreased below 7.7 g d dL-1 and were then maintained at hemoglobin concentrations between 7.7 and 9.9 g d dL-1.
liberal transfusion strategy	Active comparator	Procedure: liberal transfusion strategyPatients assigned to the liberal strategy were transfused when their hemoglobin concentration fell below 9.9 g dL-1, aiming at maintaining hemoglobin at or above 10 g dL-1.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Adult patients, American Society of Anesthesiologists (ASA) distribution I-III, scheduled for elective upper major abdominal surgery

Key exclusion criteria (8 listed)

history of bleeding diathesis
hereditary hemostatic defects such as hemophilias
chronic anticoagulant administration
refusal of transfusions for religious reasons
ischemic heart disease (unstable angina or myocardial infarction within the last six months)

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
restrictive transfusion strategyPatients allocated to the restrictive transfusion strategy were transfused only when their hemoglobin concentration decreased below 7.7 g d dL-1 and were then maintained at hemoglobin concentrations between 7.7 and 9.9 g d dL-1.	Procedure or surgery	restrictive transfusion strategy
liberal transfusion strategyPatients assigned to the liberal strategy were transfused when their hemoglobin concentration fell below 9.9 g dL-1, aiming at maintaining hemoglobin at or above 10 g dL-1.	Procedure or surgery	liberal transfusion strategy

Primary outcome

The number of units transfused per patient as well as the incidence of blood transfusions in each transfusion strategy group (restrictive versus liberal)
Time frame: first five postoperative days

4 secondary outcomes

time of initial mobilization postoperatively
Time frame: first five postoperative days
time of first liquid food intake
Time frame: first five postoperative days
time of first solid food intake
Time frame: first five postoperative days
incidence of postoperative infectious complications
Time frame: first five postoperative days

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 15 Feb 2019.
Background: PubMed 1393463Baigrie RJ, Lamont PM, Kwiatkowski D, Dallman MJ, Morris PJ. Systemic cytokine response after major surgery. Br J Surg. 1992 Aug;79(8):757-60. doi: 10.1002/bjs.1800790813.
Background: PubMed 18354101Koch CG, Li L, Sessler DI, Figueroa P, Hoeltge GA, Mihaljevic T, Blackstone EH. Duration of red-cell storage and complications after cardiac surgery. N Engl J Med. 2008 Mar 20;358(12):1229-39. doi: 10.1056/NEJMoa070403.
Background: PubMed 11222359Vamvakas EC, Blajchman MA. Deleterious clinical effects of transfusion-associated immunomodulation: fact or fiction? Blood. 2001 Mar 1;97(5):1180-95. doi: 10.1182/blood.v97.5.1180. No abstract available.
Background: PubMed 12199847Leal Noval SR, Jara Lopez I. Do multiple blood transfusions predispose for a higher rate of non-blood-related infection complications? Clin Microbiol Infect. 2002 Jul;8(7):383-7. doi: 10.1046/j.1469-0691.2002.00465.x.
Background: PubMed 9971864Hebert PC, Wells G, Blajchman MA, Marshall J, Martin C, Pagliarello G, Tweeddale M, Schweitzer I, Yetisir E. A multicenter, randomized, controlled clinical trial of transfusion requirements in critical care. Transfusion Requirements in Critical Care Investigators, Canadian Critical Care Trials Group. N Engl J Med. 1999 Feb 11;340(6):409-17. doi: 10.1056/NEJM199902113400601.
Background: PubMed 8614042Sherry RM, Cue JI, Goddard JK, Parramore JB, DiPiro JT. Interleukin-10 is associated with the development of sepsis in trauma patients. J Trauma. 1996 Apr;40(4):613-6; discussion 616-7. doi: 10.1097/00005373-199604000-00016.
Background: PubMed 19138255Bilgin YM, Brand A. Transfusion-related immunomodulation: a second hit in an inflammatory cascade? Vox Sang. 2008 Nov;95(4):261-71. doi: 10.1111/j.1423-0410.2008.01100.x.
Results publication: PubMed 24804272Theodoraki K, Markatou M, Rizos D, Fassoulaki A. The impact of two different transfusion strategies on patient immune response during major abdominal surgery: a preliminary report. J Immunol Res. 2014;2014:945829. doi: 10.1155/2014/945829. Epub 2014 Apr 3.

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.

Kassiani Theodoraki, PhD, DEAA principal investigator

Aretaieion University Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 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 15 Feb 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 Greece. 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?

The number of units transfused per patient as well as the incidence of blood transfusions in each transfusion strategy group (restrictive versus liberal) (time frame: first five postoperative days). 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 NCT02020525, which also lists 8 linked publications.

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 15 Feb 2019; AzTrials last refreshed its copy on 26 Oct 2026.