Clinical Trials

Beaumont Health System, with three hospitals in the northern Detroit suburbs serving southern Michigan and beyond, is a highly productive contributor to clinical trials across the nation. The Beaumont Research Institute, established by the hospital’s Board of Trustees in 1966, strengthens Beaumont's ability to conduct medical research and to provide a research training experience for the medical staff and participants in graduate medical education programs.

PLATELET-ORIENTED INHIBITION IN NEW TIA AND MINOR ISCHEMIC STROKE (POINT) TRIAL

Status: open and enrolling

Approval Date: 3/2/2012

A transient ischemic attack (TIA) is a transient episode of neurological dysfunction caused by focal brain, spinal cord, or retinal ischemia, without acute infarction. An ischemic stroke is a cerebral infarction. In POINT, eligibility is limited to brain TIAs and to minor ischemic strokes (with an NIH Stroke Scale [NIHSS] score less than or equal to 3).  TIAs are common, and are often harbingers of disabling strokes. Approximately 250,000-350,000 TIAs are diagnosed each year in the US. Given median survival of more than 8 years [32], there are approximately 2.4 million TIA survivors. In a national survey, one in fifteen of those over 65 years old reported a history of TIA [33], which is equivalent to a prevalence of 2.3 million in older Americans. Based on the prevalence of undiagnosed transient neurological events, the true incidence of TIA may be twice as high as the rates of diagnosis. Based on our review of the National Inpatient Sample for 1997-2003, there were an average of 200,000 hospital admissions for TIA each year, with annual charges climbing quickly in the period to $2.6 billion in 2003.  This study will evaluate differences in outcomes of patients randomized to treatment with Plavix+aspirin OR placebo+aspirin.


NSABP/NCIC CTG MA.32.F: BIOBEHAVIORAL MECHANISMS OF FATIGUE IN PATIENTS TREATED ON NCIC CTG MA.32: A PHASE III RANDOMIZED TRIAL OF METFORMIN VERSUS PLACEBO ON RECURRENCE AND SURVIVAL IN EARLY STAGE BREAST CANCER

Study of Biomarkers Associated With Fatigue in Patients With Early-Stage Breast Cancer Treated With Metformin or Placebo on NCIC-CTG-MA.32

Status: open and enrolling

Approval Date: 2/29/2012

RATIONALE: Studying samples of blood in the laboratory from patients with breast cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to fatigue.  PURPOSE: This research study is studying biomarkers associated with fatigue in patients with early-stage breast cancer treated with metformin or placebo on NCIC-CTG-MA.32.


THE EFFICACY OF TRANSVERSE ABDOMINIS PLANE (TAP) BLOCK IN CHILDREN UNDERGOING HYDROCELECTOMY OR HERNIA REPAIR

Status: open and enrolling

Approval Date: 2/24/2012

More information can be found at  http://clinicaltrials.gov/show/NCT01698268.

This single-center, prospective, single blind, randomized study will enroll 50 subjects who are scheduled for elective hydrocelectomy and/or hernia repair. At Beaumont Health System, post-operative pain management in children is managed either via oral/parenteral opiates and opiate adjuncts, surgeon-administered field blocks (instillation of local anesthetics in the general area of incision), or via regional techniques (spinal, epidural, or peripheral nerve blocks). We have designed this study to determine if there is improved qualitative and quantitative post-operative pain control in patients receiving TAP block versus intraoperative peri-incisional, surgeon administered field block. Once informed consent has been given, each patient will be randomized (like flip of the coin) to either Transverse Abdominis Plane Block (TAP Block)or surgeon administered anesthesia.


[PROTOCOL 25-3002] PIVOTAL CLINICAL STUDY OF THE CARDIOFOCUS ENDOSCOPIC ABLATION SYSTEM - ADAPTIVE CONTACT (EAS-AC) OR HEARTLIGHT FOR THE TREATMENT OF SYMPTOMATIC ATRIAL FIBRILLATION

Status: open and enrolling

Approval Date: 2/14/2012

The purpose of this study is to demonstrate the safety and effectiveness of the CardioFocus Endoscopic Ablation System with Adaptive Contact (HeartLight) in the treatment of atrial fibrillation by creating electrical isolation of the pulmonary veins.


EVALUATION OF AN ORAL NUTRITIONAL SUPPLEMENT CONTAINING AN777 IN OLDER HOSPITALIZED PATIENTS (PROTOCOL NUMBER BK33)

Status: open and enrolling

Approval Date: 2/1/2012

To evaluate the effect of an experimental oral nutritional supplement containing AN777 compared to another oral nutritional supplement in a malnourished, elderly population.