UMEM Research Studies

COMPARE-VOE

Sponsor: Duke University - NHLBI/NIH | Status: Recruiting

Start Date: 04/01/2019 | End Date: -

Principal Investigator(s)
Gentry Wilkerson

Secondary Investigator(s)
Sarah Dubbs

Description:

Title: A Comparison of Individualized vs. Weight Based Protocols to Treat Vaso-occlusive episodes in Sickle Cell Disease (COMPARE-VOE)

Study chairs:  

Paula Tanabe, Ph.D, CCC PI

Huiman Barnhart, Ph.D., DCC PI

Site Principal Investigator: R. Gentry Wilkerson, MD, FACEP, FAAEM

Research Team: 

Dana Beach (dbeach3@som.umaryland.edu)

Kyra Lasko (kyra.lasko@som.umaryland.edu)

Youssef Annous (yannous@som.umaryland.edu)

Sponsor: Duke University - NHLBI/NIH

Objectives: To compare the two analgesic protocols recommended by the NHLBI for treating VOE in the Emergency Department

Study design: A Phase III single-blinded randomized study of approximately 460 participants to capture data on 230 participants with one ED visit in the study population. There will be a 1:1 treatment allocation to receive opioid analgesic management for Vaso-occlusive crisis either via a weight-based analgesic protocol, or a patient-specific analgesic protocol developed by their primary Sickle Cell Disease outpatient provider.

Primary Endpoint: Change in pain scores in the ED from the time of placement in the treatment area to the time of disposition (hospital admission, discharged home or assigned to observation status) or a maximum treatment duration of 6 hours, whichever comes first.

Secondary Endpoints:

1- ED length of stay 

2- Hospitalization for pain control

3- Return ED visits, hospitalizations, or day hospital visits within seven days of index ED visit

Keywords: Sickle Cell Disease, Vaso-occlusive episodes, Acute pain crisis, Opioid, Analgesia