Clinical Research Office (CRO)

At the University of Colorado Department of Surgery, our mission is to empower clinical investigators with the tools, support, and infrastructure needed to successfully achieve their research goals. We are committed to advancing high-quality, patient-centered research that drives innovation and improves outcomes.

Our dedicated research team brings extensive experience and a deep commitment to patient safety, scientific integrity, and excellence in clinical investigation. We actively participate in a wide range of clinical trials, offering patients access to cutting-edge treatments that may not be available elsewhere.

As a leading academic medical center, we believe that research is essential to delivering the best possible care. By integrating research into our clinical practice, we provide our patients with more options, more hope, and the highest standard of care.

GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis Post-Approval Study (AAA 24-01)

Donald L Jacobs, MD, MS, DFSVS | Division of Vascular Surgery

This prospective, single-arm, multicenter post-market study evaluates the real-world safety and performance of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) in patients undergoing endovascular repair of thoracoabdominal and pararenal aortic aneurysms. Sponsored by W. L. Gore & Associates, Inc., the study aims to confirm the benefit-risk profile of the TAMBE Device and assess the effectiveness of its training program. A total of 300 subjects will be enrolled across up to 60 U.S. sites, with follow-up extending to 10 years.

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of siRNA Gene Silencing for the Treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH) in Participants with Genetic Risk Factors

Amanda Wieland, MD |Division of Transplant Surgery

The ALN-HSD-NASH-2130 trial is a randomized, double-blind, placebo-controlled Phase 2 study evaluating the efficacy and safety of ALN-HSD, a precision medicine approach using gene silencing to treat a chronic liver disease called metabolic dysfunction-associated steatohepatitis (MASH) in individuals at increased genetic risk for this condition. The study aims to assess whether ALN-HSD can reduce liver fibrosis and improve histological features of MASH. Approximately 90 participants will be enrolled and randomized 1:1 to receive either 400 mg ALN-HSD or placebo via subcutaneous injection every four weeks for 52 weeks, followed by a 32-week safety follow-up.

Randomized Comparison of the Clinical Outcome of Single Versus Multiple Arterial Grafts: The ROMA Trial

Jessica Rove, MD | Division of Cardiothoracic Surgery

The ROMA trial is a large, international, multicenter, event-driven randomized controlled trial designed to evaluate whether using multiple arterial grafts (MAG) during coronary artery bypass grafting (CABG) improves long-term outcomes compared to a single arterial graft (SAG). Enrolling over 4,300 patients across at least 25 centers, the study’s primary composite endpoint includes all-cause mortality, stroke, myocardial infarction beyond 72 hours post-surgery, and repeat revascularization. ROMA also includes a dedicated sub-study, ROMA Women, to address sex-specific outcomes in CABG, aiming to enroll 2,000 women and assess both clinical and quality-of-life endpoints over long-term follow-up of up to 12 years.

Antithrombin to Improve Thromboprophylaxis and Reduce the Incidence of Trauma-Related Venous Thromboembolism (TRAIT)

Michael Cripps, MD, MSCS, FACS | Division of GI, Trauma, and Endocrine Surgery

The TRAIT trial is a multicenter, randomized, double-blind, placebo-controlled Phase 2 study evaluating the efficacy of early intravenous antithrombin (Thrombate) supplementation in trauma patients at high risk for venous thromboembolism (VTE). Although patients usually receive a medication called enoxaparin to prevent clots, many still develop them. This study compares two groups of patients: one receiving Thrombate and the other receiving a placebo, both alongside standard treatment. A total of 314 patients will be enrolled, with pharmacokinetic and biomarker sampling over the first 7 days.