In Collaboration with Duke Nursing, Faculty Huiman Barnhart will lead a Data Coordinating Center

Recent Updates

Dec. 6, 2018

The National Heart, Lung, and Blood Institute National Institutes of Health (NHLBI) recently awarded B&B faculty Dr. Huiman Barnhart a four year study to lead the Data Coordinating Center (DCC) for a new phase III randomized clinical trial, A Comparison of Individualized vs. Weight Based Protocols to Treat Vaso-Occlusive Episodes in Sickle Cell Disease (COMPARE-VOE). The award for first year is just over $1.3 million, and is expected to reach more than $5.7 million over the next four-year period. 

The NHLBI also awarded Dr. Paula Tanabe separately in Duke School of Nursing to lead the clinical coordinating center for this trial. These two awards are the fruit of collaboration between Duke Clinical Research Institute in School of Medicine and Duke School of Nursing. Dr. Tanabe led a pilot study on pain management approaches for sickle cell disease patients that laid the foundation for this new Phase III trial. This phase III study includes a total of 6 clinical sites. 

Sickle cell disease is a group of inherited red blood cell disorders in which patients have an abnormal protein in their red blood cells that can cause a range of serious symptoms and complications. It is a lifelong illness, although its severity varies widely from person to person. When patients with sickle cell disease arrive at a hospital emergency department (ED), they are often in significant pain from an acute vaso-occlusive episode (VOE), a common complication of sickle cell disease. With no standard treatment approach in most EDs, patients are likely to receive doses of pain medication that are highly variable. This results in pain treatment that patient surveys frequently describe as inadequate. The new phase III randomized clinical trial is aimed to determine whether an individual patient-based analgesic protocol would provide greater relief than a protocol based on the patient’s weight. The primary goal of this study is to improve patient-reported pain scores between their arrival and departure from the ED.

A major challenge in conducting such a trial is the ED setting – most patients are in too much pain to provide informed consent. Because of this logistical difficulty, this trial use an innovative study design where potential patients will be randomized beforehand during a routine clinic visit and not all randomized patients will be enrolled in the phase III trial.  If the randomized patients later visit the ED for a VOE, they will be enrolled in the trial immediately where the randomized pain management protocol (that has been uploaded in the health care system upon randomization)  is available for immediate use by the ED healthcare providers.  While patients will be told what pain medication they are taking, they will not know their assigned pain management protocol.

Additional information about this Duke Clinical Research Institute study can be found on dcri.org.

Photo: Hongqiu Yang (Statistics Operation), Sheri Ussery (Lead Clinical Research Associate), Huiman Barnhart (DCC PI), Paula Tanabe (CCC PI), Coleen Crespo (Data management), Beth Martinez (DCC Project Leader), Jackie Brown (CCC Project Leader).