Transfusion Trigger After Operations in High Cardiac Risk Patients

Completed · Not applicable

Conditions studied: Myocardial Infarction, Coronary Revascularization, Acute Renal Failure

In brief

The goal of the proposed study is to determine whether a liberal transfusion strategy (transfusion trigger at Hb \< 10 gm/dl) in Veterans at high cardiac risk who undergo major open vascular and general surgery operations is associated with decreased risk of adverse postoperative outcomes compared to a restrictive transfusion strategy (transfusion trigger at Hb \< 7 gm/dl).

Key facts

Study ID

NCT03229941

Run by

VA Office of Research and Development

People needed

1424

Starts

2018-02-05

Expected to finish

2024-03-02

Last updated by the study team

2025-11-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Central Arkansas VHS John L. McClellan Memorial Veterans Hospital, Little Rock, AR — Little Rock, Arkansas, United States
• VA Loma Linda Healthcare System, Loma Linda, CA — Loma Linda, California, United States
• VA Long Beach Healthcare System, Long Beach, CA — Long Beach, California, United States
• VA Palo Alto Health Care System, Palo Alto, CA — Palo Alto, California, United States
• San Francisco VA Medical Center, San Francisco, CA — San Francisco, California, United States
• North Florida/South Georgia Veterans Health System, Gainesville, FL — Gainesville, Florida, United States
• James A. Haley Veterans' Hospital, Tampa, FL — Tampa, Florida, United States
• Minneapolis VA Health Care System, Minneapolis, MN — Minneapolis, Minnesota, United States
• VA Western New York Healthcare System, Buffalo, NY — Buffalo, New York, United States
• Asheville VA Medical Center, Asheville, NC — Asheville, North Carolina, United States
• Louis Stokes VA Medical Center, Cleveland, OH — Cleveland, Ohio, United States
• VA Portland Health Care System, Portland, OR — Portland, Oregon, United States
• VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA — Pittsburgh, Pennsylvania, United States
• VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX — Dallas, Texas, United States
• Michael E. DeBakey VA Medical Center, Houston, TX — Houston, Texas, United States
• VA Puget Sound Health Care System Seattle Division, Seattle, WA — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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