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Blood transfusion thresholds tested to save elderly surgical patients

NCT ID NCT03369210

Disease control Sponsor: Johann Wolfgang Goethe University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 07, 2026 · Last updated Jul 22, 2026 · Updated 3 times

Summary

This study tests whether giving blood transfusions more liberally (when hemoglobin drops to 9 g/dL) versus more restrictively (when it drops to 7.5 g/dL) reduces death and serious complications like heart attack, stroke, or kidney injury in patients aged 70 and older undergoing non-cardiac surgery. The trial randomly assigns participants to one of the two transfusion strategies and follows them for 90 days after surgery. The goal is to find the safest approach for managing anemia in this vulnerable population.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
red blood cell transfusion
What this could lead to
If liberal transfusion proves superior, it could establish a new standard for managing anemia in elderly surgical patients, potentially reducing deaths and complications.
What could go wrong
The trial is large but results may not apply to all surgeries or hospitals. Liberal transfusion carries risks like fluid overload or transfusion reactions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

4,456 people

The number who actually took part.

Started

Jan 2018

Finished

Apr 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

70 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients ≥ 70 years of age scheduled for intermediate- or high-risk non-cardiac surgery will be registered * Registered patients will be randomised only if they indeed develop severe anaemia (if Hb level falls ≤ 9 g/dl) during surgery (=day 0) or day 1, 2, or 3 after surgery Exclusion Criteria: * preoperative Hb level ≤ 9 g/dl * chronic kidney disease requiring dialysis * suspected lack of compliance with follow-up procedures * participation in other interventional trials * expected death within 3 months * inability to provide informed consent with absence of a legally authorised representative/ legal guardian * temporary inability to provide informed consent * previous participation in our trial * patients who are prevented from having blood and blood products according to a system of beliefs (e.g. Jehovah's Witnesses) * preoperative autologous blood donation.

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Conditions

The condition(s) this trial relates to.

anemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anemia Surgery Transfusion-dependent anemia

Contacts and locations

Locations

  • Berlin Charite CCM

    Berlin, Germany

  • Charite Berlin CBF

    Berlin, Germany

  • Klinikum Dortmund

    Dortmund, Germany

  • St. Franziskus Hospital Münster

    Münster, Germany

  • University Hospital Augsburg

    Augsburg, Germany

  • University Hospital Bonn

    Bonn, Germany

  • University Hospital Frankfurt

    Frankfurt, Germany

  • University Hospital Giessen

    Giessen, Germany

  • University Hospital Greifswald

    Greifswald, Germany

  • University Hospital Hamburg

    Hamburg, Germany

  • University Hospital Jena

    Jena, Germany

  • University Hospital Mainz

    Mainz, Germany

  • University Hospital Münster

    Münster, Germany

  • University Hospital RWTH

    Aachen, Germany

  • University Hospital Regensburg

    Regensburg, Germany

  • University Hospital Schleswig-Holstein

    Kiel, Germany

  • University Hospital Würzburg

    Würzburg, 97080, Germany

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