Myocardial Infarction Clinical Trial
— TOPOfficial title:
CSP #599 - Transfusion Trigger After Operations in High Cardiac Risk Patients (TOP)
NCT number | NCT03229941 |
Other study ID # | 599 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | February 5, 2018 |
Est. completion date | March 2, 2024 |
Verified date | March 2024 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 | Completed |
Enrollment | 3012 |
Est. completion date | March 2, 2024 |
Est. primary completion date | June 2, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Asheville VA Medical Center, Asheville, NC | Asheville | North Carolina |
United States | VA Western New York Healthcare System, Buffalo, NY | Buffalo | New York |
United States | Louis Stokes VA Medical Center, Cleveland, OH | Cleveland | Ohio |
United States | VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX | Dallas | Texas |
United States | North Florida/South Georgia Veterans Health System, Gainesville, FL | Gainesville | Florida |
United States | Michael E. DeBakey VA Medical Center, Houston, TX | Houston | Texas |
United States | 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 | Minneapolis VA Health Care System, Minneapolis, MN | Minneapolis | Minnesota |
United States | VA Palo Alto Health Care System, Palo Alto, CA | Palo Alto | California |
United States | VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA | Pittsburgh | Pennsylvania |
United States | VA Portland Health Care System, Portland, OR | Portland | Oregon |
United States | San Francisco VA Medical Center, San Francisco, CA | San Francisco | California |
United States | VA Puget Sound Health Care System Seattle Division, Seattle, WA | Seattle | Washington |
United States | James A. Haley Veterans' Hospital, Tampa, FL | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | The investigators will examine individual rates of the outcomes that consist of individual components of the primary endpoint. | All cause postoperative mortality, Postoperative MI, Postoperative coronary revascularization, Postoperative stroke,Postoperative acute renal failure | 90 days after randomization | |
Primary | A composite endpoint of all-cause post-randomization mortality, myocardial infarction (MI), coronary revascularization, acute renal failure, or post-randomization ischemic stroke up to 90 days after randomization. | MI will be defined using the Third Universal Definition of Myocardial Infarction. Acute renal failure will be defined as Acute Kidney Injury stage III according to RIFLE criteria. Baseline creatinine will be considered the creatinine upon admission prior to the index operation. The above urine output criteria will be only used for patients who are in the ICU and have precise monitoring of their urinary output. For patients on the surgical floor only serum creatinine changes will be used for assessment of this endpoint. Coronary revascularization will be defined as a coronary artery bypass graft, or percutaneous coronary intervention (either angioplasty or stenting). Stroke will be defined as new unilateral neurological deficit that lasts for more than 24 hours, and is confirmed by a brain imaging modality (computed tomography or magnetic resonance imaging study) demonstrating new brain infarct. | 90 days after randomization | |
Secondary | A composite endpoint of postoperative infectious complications at 90 days post-randomization: Infectious complications will include wound infections, pneumonia, and sepsis. | Wound infection will be defined according to the Centers for Disease Control and Prevention (CDC) guidelines as a) positive wound culture, or b) drainage of pus from a wound, or c) suspicion of wound infection that was drained operatively.
Pneumonia will be defined according to the CDC definition as chest radiograph with new or progressive infiltrate, consolidation, cavitation, or pleural effusion and any of the following: new onset of purulent sputum or change in character of sputum, or organism isolated from blood culture, trans-tracheal aspirate, bronchial brushings, or biopsy. Sepsis will be defined as a combination of two of the following systemic inflammatory response syndrome (SIRS) criteria, plus suspected or present source of infection. SIRS criteria will include the following: temperature greater than 38C, heart rate greater than 90 beats/min, WBC > 12,000 or < 4,000, or > 10% bands. |
90 days after randomization | |
Secondary | A composite endpoint of cardiac complications (other than MI) at 90 days post-randomization: Cardiac complications will include new cardiac arrhythmias that necessitate new treatment, new or worsening congestive heart failure (CHF), and cardiac arrest no | The diagnosis of cardiac arrhythmias will be based on EKG findings. Only arrhythmias that result in initiation of new treatment regimen (to include medications, implantable devices, or surgical intervention) during hospitalization will be recorded.
CHF will require at least one of the following symptoms or signs new or worsening: dyspnea at rest, orthopnea, or paroxysmal nocturnal dyspnea and radiological evidence of heart failure or worsening heart failure and increase/initiation of established treatment. Cardiac arrest will be defined as the cessation of cardiac pump function activity that results in loss of consciousness and absence of circulating blood flow as evidenced by absent carotid pulse. Only episodes of cardiac arrest that are reversed will be collected under this endpoint. If they are not reversed the event will be categorized as death. |
90 days after randomization | |
Secondary | All-cause mortality at 1 year after randomization. | The investigators will determine vital status by telephoning participants after hospital discharge, by searching the electronic medical record and the National Death Index. | 12 months after randomization | |
Secondary | A composite endpoint of all-cause mortality, | MI, coronary revascularization, acute renal failure, or postoperative ischemic stroke. | 30 days after randomization | |
Secondary | Length of hospital stay. | Length of hospital stay | At hospital discharge, up to 1 year |
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