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.

STROKE HYPERGLYCEMIA INSULIN NETWORK EFFORT (SHINE) TRIAL

Status: open and enrolling

Approval Date: 3/7/2012

The Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial is a multicenter, randomized, controlled clinical trial of 1400 patients that will include approximately 60 enrolling sites. The study hypotheses are that treatment of hyperglycemic acute ischemic stroke patients with targeted glucose concentration (80mg/dL - 130 mg/dL) will be safe and result in improved 3 month outcome after stroke.


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.


EFFICACY OF FASCIA ILIACA BLOCK VERSUS INTRAOPERATIVE NERVE INFILTRATION DURING ANTERIOR HIP REPLACEMENT SURGERY

Status: open and enrolling

Approval Date: 3/2/2012

More information can be found at http://clinicaltrials.gov/show/NCT01693900.

Surgical trauma causes nerve sensitization leading to amplification and prolongation of postoperative pain. In experimental studies, pre-injury neural blockade using local anesthetics has been shown to reduce post-injury sensitization of the central nervous system, while similar techniques applied after the injury had less or no effect (FILOS). Investigators have therefore designed this study to examine the timing of FICB (pre-operatively versus intra-operatively) on postoperative pain in patients undergoing anterior hip replacement surgery.


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.