Comparing Individualized vs. Weight Based Protocols to Treat Vaso-Occlusive Episodes in Sickle Cell Disease

Stopped early · Phase 3

Conditions studied: Sickle Cell Disease

In brief

The purpose of this research study is to compare two different ways to give opioid pain medicine to treat sickle cell disease pain that is bad enough to go to the emergency department for treatment. One way uses your weight to decide how much pain medicine to give you while in the emergency department. This is called weight based treatment. The other way uses how much pain medicine you take at home and how much medicine you needed during past emergency department visits to decide how much medicine to give you. This is called patient specific treatment.

Key facts

Study ID

NCT03933397

Run by

Duke University

People needed

328

Starts

2019-08-13

Expected to finish

2022-05-20

Last updated by the study team

2023-07-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All adult (18 years or older);
• Sickle Cell Disease patients with the following genotypes: Hgb SS (sickle cell anemia), SC(Sickle hemoglobin-c) , and SB+(sickle Beta-Plus thalassemia) and SB-(sickle Beta zero thalassemia)

You may not qualify if…

• determined to not benefit from opioids and therefore won't receive opioids in any future Emergency Department visit.

Where it is running

• University of Maryland — Baltimore, Maryland, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Wayne State University — Detroit, Michigan, United States
• Atrium Health — Charlotte, North Carolina, United States
• Case Western University — Cleveland, Ohio, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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