Status:
COMPLETED
Transfusion Trigger After Operations in High Cardiac Risk Patients
Lead Sponsor:
VA Office of Research and Development
Conditions:
Myocardial Infarction
Coronary Revascularization
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 gener...
Detailed Description
Background: Despite the need for clinically appropriate use of blood products in the postoperative setting, blood transfusion practices are empiric and variable. In the absence of a physiologic test t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 2 2024
Estimated Enrollment :
1424 Patients enrolled
Trial Details
Trial ID
NCT03229941
Start Date
February 5 2018
End Date
March 2 2024
Last Update
November 21 2025
Active Locations (16)
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1
Central Arkansas VHS John L. McClellan Memorial Veterans Hospital, Little Rock, AR
Little Rock, Arkansas, United States, 72205-5484
2
VA Loma Linda Healthcare System, Loma Linda, CA
Loma Linda, California, United States, 92357
3
VA Long Beach Healthcare System, Long Beach, CA
Long Beach, California, United States, 90822
4
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, United States, 94304-1290