NCT03229941Completed
Transfusion Trigger After Operations in High Cardiac Risk Patients
CSP #599 - Transfusion Trigger After Operations in High Cardiac Risk Patients (TOP)
Source: ClinicalTrials.gov · Last updated 21 Nov 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 1424 (actual)
- First submitted
- 7 Jul 2017
- Start date
- 5 Feb 2018
- Primary completion date
- 2 Jun 2023
- Lead sponsor
- VA Office of Research and Development
- Diseases
- Coronary artery disease
- NCT number
- NCT03229941
What you commit to
- Study type: Interventional
- Participants enrolled: 1424
- From 5 Feb 2018 to the primary completion date, 2 Jun 2023
- 16 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Veteran with prior history of adverse reaction to blood administration, such as fever, rash, or hemolysis
- 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.
Other illness
- 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
Other
- Veteran unable to consent
- Veteran unwilling to follow protocol (such as Jehovah's witnesses)
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (16)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Asheville VA Medical Center, Asheville, NC Coordinator of this site? Confirm its status | Asheville | United States | Unknown status |
| VA Western New York Healthcare System, Buffalo, NY Coordinator of this site? Confirm its status | Buffalo | United States | Unknown status |
| Louis Stokes VA Medical Center, Cleveland, OH Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| North Florida/South Georgia Veterans Health System, Gainesville, FL Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
| Michael E. DeBakey VA Medical Center, Houston, TX Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Central Arkansas VHS John L. McClellan Memorial Veterans Hospital, Little Rock, AR Coordinator of this site? Confirm its status | Little Rock | United States | Unknown status |
| VA Loma Linda Healthcare System, Loma Linda, CA Coordinator of this site? Confirm its status | Loma Linda | United States | Unknown status |
| VA Long Beach Healthcare System, Long Beach, CA Coordinator of this site? Confirm its status | Long Beach | United States | Unknown status |
| Minneapolis VA Health Care System, Minneapolis, MN Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| VA Palo Alto Health Care System, Palo Alto, CA Coordinator of this site? Confirm its status | Palo Alto | United States | Unknown status |
| VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| VA Portland Health Care System, Portland, OR Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| San Francisco VA Medical Center, San Francisco, CA Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| VA Puget Sound Health Care System Seattle Division, Seattle, WA Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| James A. Haley Veterans' Hospital, Tampa, FL Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.