Trial design of comparing patient-specific versus weight-based protocols to treat vaso-occlusive episodes in sickle cell disease (COMPARE-VOE)
| Autor: | Caroline E Freiermuth, Stephanie O Ibemere, Sarah B. Dubbs, Huiman X. Barnhart, Paula Tanabe, John J. Strouse, R. Gentry Wilkerson, Jacqueline L Brown, Judith A. Paice, Patricia L. Kavanagh, Compare-Voe study investigators |
|---|---|
| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
Population Pain Anemia Sickle Cell Disease Article law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial law medicine Clinical endpoint Humans Pain Management Pharmacology (medical) 030212 general & internal medicine education Pain Measurement Randomized Controlled Trials as Topic Analgesics education.field_of_study 030505 public health business.industry General Medicine Emergency department medicine.disease Clinical trial Emergency medicine Population study 0305 other medical science business Vaso-occlusive crisis |
| Zdroj: | Contemp Clin Trials |
| ISSN: | 1551-7144 |
| Popis: | Objectives Painful vaso-occlusive episodes (VOE) are the most common reason for emergency department (ED) visits experienced by patients with sickle cell disease (SCD). The National Heart, Lung and Blood Institute (NHLBI) evidence-based recommendations for VOE treatment are based primarily on expert opinion. In this randomized controlled trial (RCT), we will compare changes in pain scores between patients randomized to a patient-specific analgesic protocol versus those randomized to a weight-based analgesic protocol, as recommended by the NHLBI guidelines. Methods We report the rationale and design of a multi-site, phase III, single-blinded, RCT to be conducted in six EDs in the United States. Eligible participants will be randomized after providing consent, anticipating 50% of those randomized would have an ED visit during the enrollment period. A total of 230 participants with one VOE ED visit provides sufficient power to detect a clinically significant difference in pain score reductions of 14 between groups with 0.05 type I error. Uniquely, this trial randomizes participants in a larger population than the study population, given the impossibility of consenting and randomizing participants during emergencies. The primary endpoint is the change in pain scores in the ED from time of placement in treatment area to time of disposition (hospitalization, discharged home, or assigned to observation status) or a maximum treatment duration of 6 hours. Additional outcomes include hospitalizations and ED visits seven days post enrollment, side effects, and safety assessments. Conclusions The COMPARE-VOE study design will provide high-level evidence to support the NHLBI VOE treatment guidelines. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
Full Text from ScienceDirect