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When to transfuse? study tests best blood strategy for heart patients after surgery

NCT ID NCT03229941

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at 1,424 veterans at high risk for heart problems who had major surgery. It compared two approaches to blood transfusion: a liberal strategy (transfusing when hemoglobin drops below 10) versus a restrictive strategy (transfusing only when hemoglobin drops below 7). The goal was to see which approach better prevents complications like heart attack, kidney failure, stroke, or death within 90 days after surgery.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

1,424 people

The number who actually took part.

Started

Feb 2018

Finished

Mar 2024

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

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

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Males and females older than 18 years of age who have postoperative Hb \< 10gm/dl within 15 days after the index operation * Patients who undergo an operation in either one of the three following categories: * Veterans who undergo PAD - related operations including but not limited to the following: * aortobifemoral or aortobiiliac bypass * open abdominal aortic aneurysm repair with simultaneous repair of aortoiliac occlusive disease * visceral bypass * iliofemoral bypass * femoral bypass or endarterectomy * infrainguinal bypass * thromboembolectomy * supra-aortic trunk bypass or endarterectomy * carotid endarterectomy * major lower extremity amputations (transfemoral, through the knee, or transtibial) * Veterans with past medical history of ischemic stroke or IHD or PAD who undergo the following general surgery procedures, defined as: * known prior MI * ECG findings consistent with prior MI * prior percutaneous coronary intervention * prior coronary artery bypass surgery * history of angina for which the patient is currently receiving treatment * stress test indicating myocardial ischemia * who undergo the following General Surgery operations: * Open cholecystectomy or other complex biliary reconstruction * such as open common bile duct exploration for stones * reconstruction as part of oncologic operations such as palliative pancreatic cancer procedures) * small bowel resection * pancreatectomy * colon resection * rectal resection * splenectomy * transhiatal esophagectomy * liver resection * gastric resection * open ventral hernia repair * Colostomies (reversals and takedowns) * Intestinal anastomosis takedowns and revisions * Gastric bypass * Adrenalectomies * Major diaphragmatic hiatal hernia repairs * Veterans with past medical history of ischemic stroke or IHD or PAD who undergo the following Vascular Surgery operations: * Open aneurysm repair, including but not limited to: * carotid * subclavian * abdominal aortic * iliac * femoral * popliteal aneurysms * and complex endovascular aneurysm repair, defined as: * fenestrated endograft * or endograft with need for iliac conduit * or endovascular aneurysm repair with simultaneous femoral artery reconstruction or bypass * Subclavian/vertebral bypasses and transpositions * Patients undergoing the above procedures will be included in the study regardless of their preoperative Hb level, and regardless of preoperative or intraoperative transfusion they might have received. Exclusion Criteria: * Veteran unable to consent * Veteran unwilling to follow protocol (such as Jehovah's witnesses) * Veteran with known history of hereditary anemias such as Thalassemia or Sickle cell disease * Veteran with known history of hereditary bleeding disorders, such as factor VIII or factor IX deficiency * Veteran with prior history of adverse reaction to blood administration, such as fever, rash, or hemolysis * Veteran does not speak or understand English * Veteran hemodynamically unstable or in cardiogenic shock for \>48 hours after the index procedure * Veteran participating in another interventional trial whose objective is to evaluate the effect of transfusion on outcomes * Pregnancy in female Veterans * Veteran is a prisoner or in custody of law enforcement * Prior randomization in the CSP#599 * Patients who are known to have tested positive for COVID-19 and have not recovered prior to consent will not be consented. Any participant who is known to have a positive COVID-19 test during the screening process and has not recovered will be excluded prior to randomization.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Asheville VA Medical Center, Asheville, NC

    Asheville, North Carolina, 28805, United States

  • Central Arkansas VHS John L. McClellan Memorial Veterans Hospital, Little Rock, AR

    Little Rock, Arkansas, 72205-5484, United States

  • James A. Haley Veterans' Hospital, Tampa, FL

    Tampa, Florida, 33612, United States

  • Louis Stokes VA Medical Center, Cleveland, OH

    Cleveland, Ohio, 44106, United States

  • Michael E. DeBakey VA Medical Center, Houston, TX

    Houston, Texas, 77030, United States

  • Minneapolis VA Health Care System, Minneapolis, MN

    Minneapolis, Minnesota, 55417, United States

  • North Florida/South Georgia Veterans Health System, Gainesville, FL

    Gainesville, Florida, 32608, United States

  • San Francisco VA Medical Center, San Francisco, CA

    San Francisco, California, 94121, United States

  • VA Loma Linda Healthcare System, Loma Linda, CA

    Loma Linda, California, 92357, United States

  • VA Long Beach Healthcare System, Long Beach, CA

    Long Beach, California, 90822, United States

  • VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

    Dallas, Texas, 75216, United States

  • VA Palo Alto Health Care System, Palo Alto, CA

    Palo Alto, California, 94304-1290, United States

  • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

    Pittsburgh, Pennsylvania, 15240, United States

  • VA Portland Health Care System, Portland, OR

    Portland, Oregon, 97239, United States

  • VA Puget Sound Health Care System Seattle Division, Seattle, WA

    Seattle, Washington, 98108, United States

  • VA Western New York Healthcare System, Buffalo, NY

    Buffalo, New York, 14215, United States

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