{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,30]],"date-time":"2026-04-30T10:17:19Z","timestamp":1777544239297,"version":"3.51.4"},"reference-count":41,"publisher":"SAGE Publications","issue":"1","license":[{"start":{"date-parts":[[2007,2,1]],"date-time":"2007-02-01T00:00:00Z","timestamp":1170288000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Clinical Trials"],"published-print":{"date-parts":[[2007,2]]},"abstract":"<jats:p>Background Since the late 1960s, coronary artery bypass graft (CABG-only) procedures were traditionally performed using a heart-lung machine on an arrested heart (on-pump). Over the past decade, an increasing number CABG-only procedures were performed on a beating heart (off-pump). Advocates of the off-pump approach expect to reduce many of the adverse side effects related to using the heart-lung machine, while advocates for the on-pump procedure raise concerns related to graft patency rates and long-term event-free survival for the off-pump technique.<\/jats:p>\n                  <jats:p>Purpose The U.S. Department of Veteran Affairs (VA) Cooperative Studies Program funded a randomized, multicenter clinical trial comparing the clinical and resourcerelated outcomes following on-pump versus off-pump techniques for veterans undergoing a non-emergent CABG-only procedure. The planning committee was faced with several critically important challenges to assure feasibility of study costs and required sample size; generalizability to non-VA surgical practices; and comparability of clinically meaningful results. These challenges are discussed.<\/jats:p>\n                  <jats:p>Methods This study is a prospective, randomized, multicenter, single blinded (patient) clinical trial that compares on-pump and off-pump techniques for veterans requiring non-emergent CABG-only procedures. There will be 2200 patients randomized at 17 VA Medical Centers when the five-year recruitment period ends on 15 April 2007. There are two primary objectives: a short-term objective to assess the immediate impact of the two techniques on 30-day mortality\/morbidity and a long-term objective to assess one-year mortality\/morbidity. Major secondary outcomes are one-year graft patency rates and change in neuropsychological assessments from baseline to one year. All patients are assessed at 30 days post-surgery or discharge from the hospital, whichever is latest, and at one-year post-surgery.<\/jats:p>\n                  <jats:p>Results During planning, several key issues had to be decided. These included 1) choosing primary objectives: a short-term (30-day) and a long-term (one-year) objective were chosen; 2) choosing primary outcome measures: composite measures were selected to ensure sufficient end-points; 3) standardization of surgical techniques: minimal standardization required but guidelines and continuing discussions on both techniques provided; 4) establishing criteria for surgeons and residents for participation: surgeons required to have completed 20 off-pump procedures prior to doing study procedures and residents, in presence of study surgeon, capable of doing either procedure; 5) identifying metrics of cognitive dysfunction sensitive to treatment: a neuropshychologist hired who centrally monitors cognitive functioning testing; and 6) blinding participants of surgical procedure: attempt to blind participants.<\/jats:p>\n                  <jats:p>Limitations Areas of concern are whether all surgeons sufficiently experienced on the off-pump procedure, should residents have been allowed to do study surgeries, should techniques have been standardized more and were the best neurocognitive tests selected.<\/jats:p>\n                  <jats:p>Conclusion The study design presented allows for a balanced and fair assessment of the on-pump and off-pump CABG procedures across a diversity of clinical outcomes and resource use metrics. Its results have the potential to influence clinical cardiac surgical practice in the future.<\/jats:p>","DOI":"10.1177\/1740774506075859","type":"journal-article","created":{"date-parts":[[2007,2,27]],"date-time":"2007-02-27T08:28:57Z","timestamp":1172564937000},"page":"81-91","source":"Crossref","is-referenced-by-count":32,"title":["A study design to assess the safety and efficacy of on-pump versus off-pump                 coronary bypass grafting: the ROOBY trial"],"prefix":"10.1177","volume":"4","author":[{"given":"Dimitri","family":"Novitzky","sequence":"first","affiliation":[{"name":"Department of Veterans Affairs, Tampa, Florida"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"A Laurie","family":"Shroyer","sequence":"additional","affiliation":[{"name":"Department of Veterans Affairs, Denver, Colorado"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joseph F","family":"Collins","sequence":"additional","affiliation":[{"name":"Cooperative Studies Program Coordinating Center, VA Medical Center, Perry                         Point, Maryland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gerald O","family":"McDonald","sequence":"additional","affiliation":[{"name":"Department of Veterans Affairs, Washington, DC"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"John","family":"Lucke","sequence":"additional","affiliation":[{"name":"Department of Veterans Affairs, Asheville, North Carolina"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Brack","family":"Hattler","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Elizabeth","family":"Kozora","sequence":"additional","affiliation":[{"name":"Department of Veterans Affairs, Denver, Colorado"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Douglas D","family":"Bradham","sequence":"additional","affiliation":[{"name":"Cooperative Studies Program Coordinating Center, VA Medical Center, Perry                         Point, Maryland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Janet","family":"Baltz","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Frederick L","family":"Grover","sequence":"additional","affiliation":[{"name":"Department of Veterans Affairs, Denver, Colorado"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"name":"for the VA #517 Randomized On\/Off Bypass (ROOBY) Study Group","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2007,2,1]]},"reference":[{"key":"atypb1","unstructured":"American Heart Association. 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